Tolvaptan Extension Study in Participants With ADPKD

• Status: Completed
• Trial end date: 2016-02-29
• Target enrollment: 0
• Participant gender: All

Summary

To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Tolvaptan

Criteria

Inclusion Criteria:

• Participants who had successfully completed a Phase 1, 2, or 3 tolvaptan ADPKD or renal impairment study, with a confirmed diagnosis of ADPKD from prior studies [either 156-04-251 (NCT00428948) or 156-04-250 (NCT00413777), 156-06-260, 156-09-284 (NCT01336972), 156-09-285 (NCT01210560), and 156-09-290 (NCT01451827)].

Exclusion Criteria:

• Participants unable to provide written informed consent.

• Participants (men or women) would not adhere to the reproductive precautions as outlined in the Informed Consent Form.

• Participants (women only) with a positive urine pregnancy test.

• Participants who were pregnant or breast-feeding.

• Participants unable to take oral medications.

• Participants who had allergic reactions to tolvaptan or chemically related structures such as benzazepines (benzazepril, conivaptan, fenoldopam mesylate, or mirtazapine).

• Participants with disorders in thirst recognition or an inability to access fluids.

• Participants with critical electrolyte imbalances, as determined by the investigator

• Participants with or at risk of significant hypovolemia, as determined by investigator.

• Participants with significant anemia, as determined by investigator.

• Participants with a history of substance abuse (within the last 3 years).

• Participants who were taking other experimental (that is, non-marketed) therapies or were participating in another clinical drug or device study; participating in the off-drug follow-up period of another ADPKD trial with tolvaptan was permitted.

• Participants unable to complete magnetic resonance imaging (MRI) assessments (for example, participants with ferro-magnetic prostheses, aneurysm clips, severe claustrophobia).

• Participants who had taken a vasopressin antagonist (outside of previous participation in a tolvaptan study).

• Participants unable to comply with anti-hypertensive or other important medical therapy.

• Participants with advanced diabetes.

• Participants who were taking medications or had an illness that could confound endpoint assessments (including taking approved therapies for the purpose of affecting polycystic kidney disease [PKD] cysts).