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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02160145
Registration number
NCT02160145
Ethics application status
Date submitted
6/06/2014
Date registered
10/06/2014
Date last updated
8/08/2018
Titles & IDs
Public title
Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
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Scientific title
A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
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Secondary ID [1]
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156-13-210
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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:
Chronic Kidney Disease
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0
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Autosomal Dominant Polycystic Kidney Disease
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Condition category
Condition code
Musculoskeletal
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0
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Other muscular and skeletal disorders
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Renal and Urogenital
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0
0
0
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Kidney disease
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Renal and Urogenital
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0
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Other renal and urogenital disorders
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Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tolvaptan (OPC-41061)
Treatment: Drugs - Placebo
Experimental: Tolvaptan - Tolvaptan (OPC-41061)
Placebo comparator: Placebo - Placebo
Treatment: Drugs: Tolvaptan (OPC-41061)
Tolvaptan tablets (15 or 30 mg) will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later.
Treatment: Drugs: Placebo
Matching placebo tablets will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later
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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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The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up.
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Assessment method [1]
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The mean annualized change in eGFR was calculated using the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula from pretreatment baseline to post-treatment follow-up, annualized (divided) by each subject's trial duration.
The baseline for the primary endpoint was defined as the average of up to 3 eGFR values observed during the screening and placebo run-in periods.
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Timepoint [1]
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Pretreatment baseline to post-treatment follow-up (up to 61 weeks).
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Secondary outcome [1]
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Mean Annualized Slope of eGFR Change
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Assessment method [1]
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To compare the efficacy of tolvaptan treatment in reducing the decline of annualized eGFR slope, as compared with placebo, in subjects with late-stage CKD due to ADPKD who tolerated tolvaptan during an initial run-in period, the annualized rate of eGFR change was derived from each individual subject's eGFR slope using the CKD-EPI formula.
The annualized eGFR change slope was derived from all eGFR observations from placebo-run-in, tolvaptan run-in, double-blind treatment and post-treatment follow-up periods using the linear mixed model of analysis. The mean annualized slope of eGFR change is presented.
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Timepoint [1]
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Pretreatment baseline to post-treatment follow-up (up to 61 weeks).
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Eligibility
Key inclusion criteria
* Male and female subjects with eGFR between 25-65 mL/min/1.73m2 (if aged 18 to55) or eGFR between 25-44 mL/min/1.73m2 (if aged 56 to <66)
* Tolvaptan naïve
* Diagnosis of ADPKD by modified pei-Ravine criteria 1) 3 cysts per kidney by sonography or 5 cysts by CT or MRI with family history of ADPKD or 2) 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history
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Minimum age
18
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Maximum age
65
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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
* Women of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of Investigational medicinal product (IMP)
* Women who are breast-feeding and/or who have a positive pregnancy test prior to receiving IMP
* Need for chronic diuretic use
* Hepatic impairment or liver function abnormalities other than that expected for ADPKD with typical cystic liver disease
* Advanced diabetes, evidence of additional significant renal disease, renal cancer, single kidney, recent renal surgery or acute kidney injury
* Contraindications to required trial assessments
* Medical history or medical findings inconsistent with safety or compliance with trial assessments
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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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
1/05/2014
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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
18/04/2017
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Sample size
Target
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Accrual to date
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Final
1370
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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- Camperdown
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- Concord
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2050 - Camperdown
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2139 - Concord
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2305 - New Lambton Heights
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2065 - St. Leonards
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2145 - Westmead
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4102 - Woolloongabba
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5000 - Adelaide
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7250 - Launceston
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3050 - Parkville
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3073 - Reservoir
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3121 - Richmond
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6000 - Perth
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Recruitment outside Australia
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Sweden
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Stockholm
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Sweden
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Uppsala
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Örebro
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Devon
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East Riding Of Yorkshire
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East Sussex
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Greater London
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Greater Manchester
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Hertfordshire
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Highland Region
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Leicestershire
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Lothian Region
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Merseyside
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North Yorkshire
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Warwickshire
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Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Otsuka Pharmaceutical Development & Commercialization, Inc.
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Summary
Brief summary
The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD)
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Trial website
https://clinicaltrials.gov/study/NCT02160145
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Trial related presentations / publications
Bennett H, McEwan P, Hamilton K, O'Reilly K. Modelling the long-term benefits of tolvaptan therapy on renal function decline in autosomal dominant polycystic kidney disease: an exploratory analysis using the ADPKD outcomes model. BMC Nephrol. 2019 Apr 23;20(1):136. doi: 10.1186/s12882-019-1290-5. Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Perrone RD, Koch G, Ouyang J, McQuade RD, Blais JD, Czerwiec FS, Sergeyeva O; REPRISE Trial Investigators. Tolvaptan in Later-Stage Autosomal Dominant Polycystic Kidney Disease. N Engl J Med. 2017 Nov 16;377(20):1930-1942. doi: 10.1056/NEJMoa1710030. Epub 2017 Nov 4.
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Public notes
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Contacts
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/45/NCT02160145/SAP_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/45/NCT02160145/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02160145
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