Tolvaptan Extension Study in Participants With ADPKD (TEMPO 4/4)
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
About this trial
This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease (ADPKD) focused on measuring Kidney Disease, ADPKD, Autosomal Dominant Polycystic Kidney Disease, Adult Polycystic Kidney Disease
Eligibility 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).
Sites / Locations
- Otsuka Investigational Site
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Arms of the Study
Arm 1
Experimental
Tolvaptan
Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 milligrams (mg) in the morning [AM]/15 mg in the evening [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily until the last participant originating from prior studies (either 156-04-251 or 156-04-250, 156-06-260, 156-09-284, 156-09-285, and 156-09-290) who was eligible for efficacy analysis completed the Month 24.