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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02617784
Registration number
NCT02617784
Ethics application status
Date submitted
27/11/2015
Date registered
1/12/2015
Date last updated
15/02/2016
Titles & IDs
Public title
A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)
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Scientific title
A Single Center, Open Label, Multiple-Dose Oral Oseltamivir Suspension Study in End-Stage-Renal Disease (ESRD) Patients on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)
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Secondary ID [1]
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NP16472
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
End Stage Renal Disease
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Oseltamivir
Experimental: Regimen A: Oseltamivir with HD - Participants will receive 30 milligrams (mg) of oseltamivir via oral suspension approximately 1 hour after alternating HD sessions. Sessions will occur three times per week within the 6.5-week study period, and participants will receive a total of 9 doses of oseltamivir.
Experimental: Regimen B: Oseltamivir with CAPD - Participants will receive 30 mg of oseltamivir via oral suspension once weekly after dialysis exchange. CAPD sessions will occur four times every 24 hours, and participants will receive a total of 6 doses of oseltamivir within the 6-week study period.
Treatment: Drugs: Oseltamivir
Oseltamivir will be given as marketed oral suspension, 30 mg after HD or CAPD treatment.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Maximum Plasma Concentration (Cmax) of Oseltamivir in HD Participants During Days 1 to 5
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Assessment method [1]
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Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in nanograms per milliliter (ng/mL).
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Timepoint [1]
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Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 1 (D1) dose
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Primary outcome [2]
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Cmax of Oseltamivir in HD Participants During Days 38 to 43
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Assessment method [2]
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Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
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Timepoint [2]
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Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 38 (D38) dose
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Primary outcome [3]
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Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5
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Assessment method [3]
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Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
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Timepoint [3]
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Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose
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Primary outcome [4]
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Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43
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Assessment method [4]
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Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
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Timepoint [4]
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Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose
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Primary outcome [5]
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Area Under the Concentration-Time Curve (AUC) of Oseltamivir in HD Participants During Days 1 to 5
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Assessment method [5]
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Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 12 hours (AUC12) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in nanograms by hours per milliliter (ng*h/mL).
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Timepoint [5]
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Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose
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Primary outcome [6]
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AUC of Oseltamivir in HD Participants During Days 38 to 43
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Assessment method [6]
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Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.
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Timepoint [6]
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Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose
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Primary outcome [7]
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AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5
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Assessment method [7]
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Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 42 hours (AUC42) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL.
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Timepoint [7]
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Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose
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Primary outcome [8]
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AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43
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Assessment method [8]
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Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC42 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.
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Timepoint [8]
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Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose
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Primary outcome [9]
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Cmax of Oseltamivir in CAPD Participants During Days 1 to 6
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Assessment method [9]
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Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
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Timepoint [9]
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Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose
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Primary outcome [10]
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Cmax of Oseltamivir in CAPD Participants During Days 36 to 43
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Assessment method [10]
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Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
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Timepoint [10]
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Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from Day 36 (D36) dose
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Primary outcome [11]
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Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6
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Assessment method [11]
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Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
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Timepoint [11]
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Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose
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Primary outcome [12]
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Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43
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Assessment method [12]
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Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.
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Timepoint [12]
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Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose
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Primary outcome [13]
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AUC of Oseltamivir in CAPD Participants During Days 1 to 6
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Assessment method [13]
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Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.
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Timepoint [13]
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Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose
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Primary outcome [14]
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AUC of Oseltamivir in CAPD Participants During Days 36 to 43
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Assessment method [14]
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Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.
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Timepoint [14]
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Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose
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Primary outcome [15]
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AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6
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Assessment method [15]
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Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC was determined from 0 to 48 hours (AUC48) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL.
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Timepoint [15]
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Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose
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Primary outcome [16]
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AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43
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Assessment method [16]
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Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC48 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.
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Timepoint [16]
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Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose
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Secondary outcome [1]
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Plasma Concentration of Oseltamivir by Timepoint in HD Participants
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Assessment method [1]
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Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.
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Timepoint [1]
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Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose
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Secondary outcome [2]
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Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
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Assessment method [2]
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Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.
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Timepoint [2]
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Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose
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Secondary outcome [3]
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Time to Maximum Plasma Concentration (Tmax) of Oseltamivir in HD Participants
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Assessment method [3]
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Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.
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Timepoint [3]
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Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose
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Secondary outcome [4]
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Tmax of Metabolite Oseltamivir Carboxylate in HD Participants
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Assessment method [4]
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Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.
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Timepoint [4]
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Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose
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Secondary outcome [5]
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Oral Plasma Clearance (CL/F) of Oseltamivir in HD Participants
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Assessment method [5]
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Plasma samples up to 12 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in liters per hour (L/h).
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Timepoint [5]
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Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D38 dose
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Secondary outcome [6]
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CL/F of Metabolite Oseltamivir Carboxylate in HD Participants
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Assessment method [6]
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Plasma samples up to 42 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.
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Timepoint [6]
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Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 and D38 dose
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Secondary outcome [7]
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Renal Clearance (CLr) of Oseltamivir in HD Participants
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Assessment method [7]
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Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h.
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Timepoint [7]
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Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose
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Secondary outcome [8]
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CLr of Metabolite Oseltamivir Carboxylate in HD Participants
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Assessment method [8]
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Plasma and urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC42]. The CLr was averaged among all participants and expressed in L/h.
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Timepoint [8]
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Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 dose; urine samples 0 to 42 hours from D1 dose
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Secondary outcome [9]
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Dialysis Clearance (CLd) of Metabolite Oseltamivir Carboxylate in HD Participants
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Assessment method [9]
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Plasma samples up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, in addition to dialyzer samples obtained on Days 3 and 40, were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd with each dose was averaged among all participants and expressed in L/h.
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Timepoint [9]
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Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from from D1 and D38 dose; dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40
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Secondary outcome [10]
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Percentage of Oseltamivir Dose Excreted as Unchanged Drug in HD Participants
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Assessment method [10]
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Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate drug excretion, computed as [amount of drug excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
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Timepoint [10]
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Urine samples 0 to 42 hours from D1 dose
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Secondary outcome [11]
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Percentage of Oseltamivir Dose Excreted as Metabolite Oseltamivir Carboxylate in HD Participants
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Assessment method [11]
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Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate metabolite excretion, computed as [amount of metabolite excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
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Timepoint [11]
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Urine samples 0 to 42 hours from D1 dose
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Secondary outcome [12]
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Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
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Assessment method [12]
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Dialyzer samples were obtained up to 5 hours from the start of dialysis on Days 3 and 40 (corresponding to HD sessions 2 and 18). Arterial concentrations were estimated using the inflow to the dialyzer, and venous concentrations were estimated using the outflow from the dialyzer. The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.
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Timepoint [12]
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Dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40
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Secondary outcome [13]
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Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
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Assessment method [13]
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0
Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.
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Timepoint [13]
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0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose
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Secondary outcome [14]
0
0
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
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Assessment method [14]
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0
Plasma samples were obtained up to 120 post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.
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Timepoint [14]
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0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose
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Secondary outcome [15]
0
0
Tmax of Oseltamivir in CAPD Participants
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Assessment method [15]
0
0
Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.
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Timepoint [15]
0
0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose
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Secondary outcome [16]
0
0
Tmax of Metabolite Oseltamivir Carboxylate in CAPD Participants
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Assessment method [16]
0
0
Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.
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Timepoint [16]
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0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose
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Secondary outcome [17]
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Elimination Rate Constant of Metabolite Oseltamivir Carboxylate in CAPD Participants
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Assessment method [17]
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0
Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The elimination rate constant was calculated as [natural log (ln)(2) divided by the half-life] and expressed as inverse hours (1/h).
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Timepoint [17]
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Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose
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Secondary outcome [18]
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Terminal Elimination Half-Life of Metabolite Oseltamivir Carboxylate in CAPD Participants
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Assessment method [18]
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0
Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The time required for the concentration to decrease by one-half was recorded and averaged among all participants and expressed in hours.
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Timepoint [18]
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Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose
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Secondary outcome [19]
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0
CL/F of Oseltamivir in CAPD Participants
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Assessment method [19]
0
0
Plasma samples up to 12 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.
Query!
Timepoint [19]
0
0
Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D36 dose
Query!
Secondary outcome [20]
0
0
CL/F of Metabolite Oseltamivir Carboxylate in CAPD Participants
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Assessment method [20]
0
0
Plasma samples up to 48 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.
Query!
Timepoint [20]
0
0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 and D36 dose
Query!
Secondary outcome [21]
0
0
CLr of Oseltamivir in CAPD Participants
Query!
Assessment method [21]
0
0
Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h.
Query!
Timepoint [21]
0
0
Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose
Query!
Secondary outcome [22]
0
0
CLr of Metabolite Oseltamivir Carboxylate in CAPD Participants
Query!
Assessment method [22]
0
0
Plasma and urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC48]. The CLr was averaged among all participants and expressed in L/h.
Query!
Timepoint [22]
0
0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 dose; urine samples 0 to 48 hours from D1 dose
Query!
Secondary outcome [23]
0
0
CLd of Metabolite Oseltamivir Carboxylate in CAPD Participants
Query!
Assessment method [23]
0
0
Plasma samples up to 120 hours and dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd was averaged among all participants and expressed in L/h.
Query!
Timepoint [23]
0
0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose
Query!
Secondary outcome [24]
0
0
Percentage of Oseltamivir Dose Renally Excreted as Unchanged Drug in CAPD Participants
Query!
Assessment method [24]
0
0
Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of drug in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
Query!
Timepoint [24]
0
0
Urine samples 0 to 48 hours from D1 dose
Query!
Secondary outcome [25]
0
0
Percentage of Oseltamivir Dose Renally Excreted as Metabolite Oseltamivir Carboxylate in CAPD Participants
Query!
Assessment method [25]
0
0
Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of metabolite in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
Query!
Timepoint [25]
0
0
Urine samples 0 to 48 hours from D1 dose
Query!
Secondary outcome [26]
0
0
Percentage of Oseltamivir Dose Eliminated by Dialysis as Unchanged Drug in CAPD Participants
Query!
Assessment method [26]
0
0
Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of drug in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
Query!
Timepoint [26]
0
0
Dialysate samples 0 to 48 hours from D1 dose
Query!
Secondary outcome [27]
0
0
Percentage of Oseltamivir Dose Eliminated by Dialysis as Metabolite Oseltamivir Carboxylate in CAPD Participants
Query!
Assessment method [27]
0
0
Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of metabolite in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.
Query!
Timepoint [27]
0
0
Dialysate samples 0 to 48 hours from D1 dose
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Eligibility
Key inclusion criteria
- Adults greater than or equal to (>/=) 18 years of age
- ESRD defined as no residual renal function or a creatinine clearance (CrCl) less than
(<) 10 milliliters per minute (mL/min)
- Well established HD or CAPD therapy over a period of 3 months with stable CrCl < 10
mL/min
- Body mass index (BMI) 18 to 34 kilograms per meter-squared (kg/m^2)
- Use of contraception among women of childbearing potential
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Clinical significant comorbid disease or terminal illness
- Known human immunodeficiency virus (HIV) or hepatitis B or C
- History of drug or alcohol abuse within the prior year
- Donation or loss of >/= 400 milliliters (mL) of blood in the 3 months prior to
Screening
- Participation in a clinical study with an investigational drug in the 3 months prior
to study drug
- Pregnant or lactating women
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2001
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2002
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Sample size
Target
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
0
0
New Zealand
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State/province [1]
0
0
Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its
metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for
end-stage renal disease (ESRD). Participants will receive 6.5 and 6 weeks of the marketed
oral oseltamivir suspension dosed according to the HD or CAPD schedule, respectively.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02617784
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Clinical Trials
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Address
0
0
Hoffmann-La Roche
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02617784
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