Status:
COMPLETED
Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Polycystic Kidney, Autosomal Dominant
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the trial was to evaluate and describe the long term safety of tolvaptan in participants with autosomal dominant polycystic kidney disease (ADPKD).
Detailed Description
This was a Phase 3b trial to evaluate and describe the long term safety of tolvaptan treatment in ADPKD participants with chronic kidney disease (CKD). Eligible participants could enroll into Trial 15...
Eligibility Criteria
Inclusion
- Male and female participants ≥ 18 years with confirmed diagnosis of ADPKD (during participation in prior tolvaptan trials) who have completed and transferred from the double-blind Trial 156-13-210 (12-month period including post treatment follow-up, regardless of whether this was on-treatment or off-treatment), or completed Trial 156-08-271 or a prior tolvaptan trial, or interrupted or discontinued treatment in a prior tolvaptan ADPKD trial other than Trial 156-13-210. Participants may be enrolled with the medical monitor approval, and additional close monitoring may be required at the beginning of the trial.
- eGFR ≥ 20 milliliter (mL)/minute (min)/1.73 meter squared (m\^2) within 3 months prior to the baseline visit. Participants who have an eGFR ≤ 20 mL/min/1.73 m\^2 may be enrolled with medical monitor approval.
Exclusion
- Need for chronic diuretic use
- Hepatic impairment based on liver function abnormalities other than that expected for ADPKD with cystic liver disease
- 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 result prior to receiving IMP.
- Participants with contraindications to required trial assessments (contraindications to optional assessments, for example, magnetic resonance imaging \[MRI\] are not a limitation).
- Participants who in the opinion of the investigator or the medical monitor, have a medical history or medical finding inconsistent with safety or trial compliance
Key Trial Info
Start Date :
October 17 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2018
Estimated Enrollment :
1803 Patients enrolled
Trial Details
Trial ID
NCT02251275
Start Date
October 17 2014
End Date
November 9 2018
Last Update
November 27 2019
Active Locations (210)
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1
Birmingham, Alabama, United States, 35233
2
Huntsville, Alabama, United States, 35805
3
Mobile, Alabama, United States, 36617
4
Phoenix, Arizona, United States, 85381