Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) - ND

• Register: EUCTR
• Last refreshed on: 2 May 2016
• Main ID: EUCTR2010-018401-10-IT
• Date of registration: 10/09/2010
• Prospective Registration: Yes
• Primary sponsor: OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALISATION INC
• Public title: Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) - ND
• Scientific title: Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) - ND
• Date of first enrolment: 24/11/2010
• Target sample size: 1500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018401-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: In Aperto non randomizzato. Regimi di Trattamento: 45/15, 60/30 e 90/30 mg di tolvaptan If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

France, Germany, Italy, Netherlands, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1) Successful completion (protocol defined completer without early termination) of a Phase 1, 2, or 3 tolvaptan ADPKD or renal impairment trial, with a confirmed diagnosis of ADPKD. 2) Estimated GFR =30 ml/min/1.73m2 within 30 days prior to enrollment (calculated using the IDMS-traceable modification of diet in renal disease [4 parameter MDRD] equation with correction for gender and race). Subjects with lower estimated GFR (eGFR) may be permitted with documented medical monitor approval prior to enrollment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Safety contraindications including: non-compliance with therapies, reproductive precautions, unawareness of thirst, severe allergic reactions to compounds with similar chemical structure as tolvaptan • Contraindications to or interference with MRI assessments • Concurrent conditions or taking therapies likely to confound endpoint assessments or prevent completion of the trial (Efficacy Analysis Exclusion Only)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 9.1 Level: LLT Classification code 10036046

Intervention(s)

Pharmaceutical Form: Tablet
Current Sponsor code: OPC-41061
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-

Pharmaceutical Form: Tablet
Current Sponsor code: OPC-41061
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-

Primary Outcome(s)

Secondary Objective: To determine whether, for placebo-treated subjects from trial 156-04-251, the annual rate of change (slope) in TKV and renal function changes during the crossover from placebo to tolvaptan treatment. To explore exposure response relationship among all subjects enrolled in this trial for changes in TKV, renal function and hypertension.

Main Objective: To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from baseline (from trial 156-04-251) in total kidney volume (TKV) and renal function.

Primary end point(s): The two primary efficacy endpoints analyzed will be in subjects continuing from protocol 156-04-251 comparing those previously treated with tolvaptan (combining all doses) to those subjects previously treated with placebo, disease modification as measured by: Percent change from 156-04-251 baseline in Total kidney volume (TKV) at Month 24 in trial 156-08-271 as compared to the percent change in TKV at 156-04-251 Month 36 measured by magnetic resonance imaging (MRI) then Change in renal function (100x1/Serum Creatinine mg/dl) at Month 24 in trial 156-08-27) as compared to change in renal function at Month 36 in protocol 156-08-251, both relative to 156-04-251 end of titration baseline.

Secondary ID(s)

156-08-271

2010-018401-10-DE