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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/NCT00559273
Registration number
NCT00559273
Ethics application status
Date submitted
15/11/2007
Date registered
16/11/2007
Date last updated
1/11/2016
Titles & IDs
Public title
A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
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Scientific title
An Open-label, Randomized, Multicenter, Parallel-group Study to Demonstrate Correction of Anemia Using Once Every 4 Weeks Subcutaneous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are Not on Dialysis
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Secondary ID [1]
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NH20052
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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:
Renal Anemia, Chronic
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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Other renal and urogenital disorders
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Blood
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Anaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Methoxy polyethylene glycol-epoetin beta
Treatment: Drugs - Darbepoetin alfa
Experimental: Mircera - Participants will receive Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
Active Comparator: Darbepoetin Alfa - Participants will receive darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
Treatment: Drugs: Methoxy polyethylene glycol-epoetin beta
1.2 mcg/kg SC monthly, starting dose
Treatment: Drugs: Darbepoetin alfa
0.45 mcg/kg SC weekly or 0.75 mcg/kg every 2 weeks, starting dose
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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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Percentage of Participants With Hemoglobin (Hb) Response
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Assessment method [1]
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Hb response was an observed increase in Hb greater than or equal to (>=) 1.0 gram per deciliter (g/dL) from baseline and an Hb concentration >= 10.0 g/dL before the end of the study without red blood cells (RBC) transfusion before response.
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Timepoint [1]
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Baseline up to Week 28
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Primary outcome [2]
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Change in Hemoglobin (Hb) Concentration Between Baseline and Evaluation Period
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Assessment method [2]
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A time adjusted average baseline Hb concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the 2 month evaluation period (Week 21 to 28). The change in Hb concentration between the baseline and evaluation period was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.
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Timepoint [2]
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Baseline (measurements at Week -2, Week -1 and Day 1) and Evaluation Period (Week 22, Week 24, Week 26, Week 28)
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Secondary outcome [1]
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Hemoglobin (Hb) Concentration Over the Time
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Assessment method [1]
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The hemoglobin concentration was measured in g/dL every 2 weeks and at final visit.
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Timepoint [1]
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Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and final visit (Week 29)
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Secondary outcome [2]
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Time to Hemoglobin Response
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Assessment method [2]
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Time to Hb response is defined as the number of study days until the first occurrence of an Hb response. Participants without events were censored at the time of evaluation. Median and 95 percent (%) confidence interval (CI) were estimated using Kaplan-Meier Survival Analysis. Hb response was an observed increase in Hb >=1.0 g/dL from baseline and an Hb concentration >= 10.0 g/dL before the end of the study without RBC transfusion before response.
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Timepoint [2]
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Baseline up to Week 28
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Secondary outcome [3]
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Percentage of Participants With Red Blood Cell (RBC) Transfusions
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Assessment method [3]
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The percentage of participants who received RBC transfusions during the titration and evaluation periods were reported.
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Timepoint [3]
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Baseline up to Week 28
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Secondary outcome [4]
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Percentage of Participants Who Had at Least 1 Hemoglobin Value Exceeding 12.0 g/dL
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Assessment method [4]
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Percentage of participants having at least one Hb value greater than (>) 12 g/dL during the first 8 weeks of the study was reported.
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Timepoint [4]
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Baseline to Week 8
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Secondary outcome [5]
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Percentage of Participants With Stable Hemoglobin Response
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Assessment method [5]
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A participant was defined as having achieved a stable Hb response, if at least 75 percent (%) of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and >=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were >=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2). There were at least 3 recorded Hb values within the time window.
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Timepoint [5]
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Baseline to Week 28
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Secondary outcome [6]
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Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response
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Assessment method [6]
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The total number of dose adjustments needed to achieve stabilized response was calculated from Day 1 until the first 8-week time window in which response was achieved. A participant was defined as having achieved a stable Hb response, if at least 75% of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and >=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were >=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2) There were at least 3 recorded Hb values within the time window.
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Timepoint [6]
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Baseline to Week 28
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Eligibility
Key inclusion criteria
- Participants with chronic kidney disease (CKD) stage 3 (creatinine clearance [CrCl]/
glomerular filtration rate [GFR] 30 to 59 milliliter per minutes per 1.73 meter square
[mL/min/1.73m^2]) or Stage 4 (CrCl/GFR 15-29 mL/min/1.73m^2) who did not require
dialysis. CrCl/GFR was estimated with the Cockcroft-Gault equation or the abbreviated
Modification of Diet in Renal Disease (MDRD) equation
- Anemia defined as baseline Hb concentration less than (<) 10.5 gram per deciliter
(g/dL)
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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
- Previous therapy with any ESA within 12 weeks prior to screening
- Renal allograft in place
- Immunosuppressive therapy in the 12 weeks prior to screening
- Overt gastrointestinal bleeding and red blood cells (RBC) transfusions within 8 weeks
before screening
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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 3
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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
1/12/2007
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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
1/10/2009
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Sample size
Target
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Accrual to date
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Final
307
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Adelaide
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Recruitment hospital [2]
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- Clayton
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Recruitment hospital [3]
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- Gosford
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Recruitment hospital [4]
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- Parkville
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Recruitment hospital [5]
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- Reservoir
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Recruitment postcode(s) [1]
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5011 - Adelaide
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Recruitment postcode(s) [2]
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3186 - Clayton
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Recruitment postcode(s) [3]
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2250 - Gosford
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Recruitment postcode(s) [4]
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3052 - Parkville
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Recruitment postcode(s) [5]
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3073 - Reservoir
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Recruitment outside Australia
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Belgium
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Aalst
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Belgium
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Roeselare
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Alberta
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Ontario
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France
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France
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Lyon
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Nice
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France
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Berlin
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Germany
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Bonn
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Germany
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Heilbronn
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Germany
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Alexandroupolis
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Larissa
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Israel
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Haifa
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Israel
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Kfar Saba
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Israel
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Petach Tikva
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Como
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Lodi
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Madrid
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Palma de Mallorca
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Valencia
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Thailand
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Nakhon Ratchasima
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Thailand
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Pathumthani
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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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Ethics approval
Ethics application status
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Summary
Brief summary
This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous
darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who
are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants
will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2
micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45
mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is
3-12 months.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00559273
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00559273
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