A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease
- Conditions
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)MedDRA version: 8.1Level: LLTClassification code 10036046Term: Polycystic kidney, autosomal dominant
- Registration Number
- EUCTR2006-002768-24-FR
- Lead Sponsor
- Otsuka Maryland Research Institute, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1500
1. Adult subjects providing informed consent:
[Defined as men or women = 18 years and = regional legal age of maturity to age 50 years, inclusive who are able to provide informed consent and/or give assent. In the US and Europe, this is generally 18 years, while in Japan it is 20 years, inclusive.]
2. Adult subjects with a diagnosis of ADPKD:
[Diagnosis of ADPKD (age 18 or 20-50) requires several cysts in each kidney (3 if by
sonography, 5 if by computed tomography (CT) or MRI) in those with a family history of ADPKD and 10 cysts (by any radiologic method) in each kidney and exclusion of other cystic kidney diseases if there is no family history. Conditions to be excluded include: multiple simple renal cysts, renal tubular acidosis, cystic dysplasia of the kidney, multicystic kidney, multilocular cysts of the kidney, medullary cystic kidney and acquired cystic disease of the kidney.]
3. Willing to comply with required reproductive precautions:
[Limited to women who are capable of becoming pregnant (ie, not abstinent, not surgically sterile by hysterectomy, bilateral oophorectomy nor those who have been postmenopausal for at least 12 consecutive months). These individuals must be willing to remain abstinent or comply with approved birth control (Protocol Section 5.4) from two-weeks prior to, and for 60 days, after taking investigational product. Further, breast-feeding is not permitted while taking tolvaptan in this trial.]
4. Estimated GFR = 60 mL/min/1.73m2 within -31 days of randomization.
[Established using Cockfroft-Gault with correction for gender and race where possible]
5. Rapid estimated rate of renal volume increase based on total renal size =750 cc by MRI at randomization.
[Excluding, as possible, those clearly meeting criteria solely due to six or fewer predominant cysts.]
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
1. Subjects who in the opinion of the trial investigator and/or sponsor present a safety risk.
[For example: Subjects having disorders in thirst recognition or inability to access fluids. Subjects who have clinically significant allergic reactions to tolvaptan or chemically related structures such as benzazepines (benzazapril or mirtazapine), those with critical electrolyte imbalances, those with clinically significant anemia, pregnant or breast-feeding women.]
2. Subjects who are unlikely to adequately comply with the trial’s procedures.
[For example: Subjects having medical conditions likely to require an extended interruption or discontinuation during the first year of trial, with recurrent recent substance abuse (illicit drugs or alcohol), with a history of persistent non-compliance with anti-hypertensive or other important medical therapy.]
3. Subjects having contraindications to, or interference with MRI assessments
[For example: ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, gadolinium reactions, large abdominal/back tattoos, etc.]
4. Subjects having concomitant illnesses likely to confound endpoint assessments
[For example: advanced diabetes (ie, fasting glucose >126 and glycosuria by dipstick), evidence of significant renal disease (ie, currently active glomerular nephritidies), renal cancer, single kidney, recent (within last 3 years) renal surgery etc.]
5. Subjects taking other experimental therapies, with previous exposure to tolvaptan, or taking approved therapies for the purpose of affecting PKD cysts
[For example: tolvaptan, anti-sense RNA therapies, rapamycin, somatostatin analogs, recent (within 3 years) or anticipated cyst decompression, etc.]
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method