Phase 3
N=1,083
Tolvaptan Extension Study in Participants With ADPKD
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Bottom Line
View on ClinicalTrials.gov: NCT01214421 ↗Enrolled (actual)
1,083
Serious AEs
24.1%
Results posted
Oct 2021
Primary outcome: Primary: Percent Change From the Baseline in Total Kidney Volume (TKV) for Study 156-04-251 Participants Enrolled in This Study (156-08-271) — 28.66; 30.58 percent change — p=0.358
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tolvaptan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From the Baseline in Total Kidney Volume (TKV) for Study 156-04-251 Participants Enrolled in This Study (156-08-271) |
28.66; 30.58 | 0.358 |
| SECONDARY Change From the Baseline in Estimated Glomerular Filtration Rate (eGFR) as Assessed by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) for Study 156-04-251 Participants Enrolled in This Study (156-08-271) |
-16.77; -19.92 | 0.0003 sig |
| SECONDARY Annualized Slope of Total Kidney Volume (TKV) for Study 156-04-251 Participants Enrolled in Study 156-08-271 |
6.164; 4.960 | 0.0462 sig |
| SECONDARY Annualized Slope of eGFR (CKD-EPI) for Study 156-04-251 Participants Enrolled in Study 156-08-271 |
-3.255; -3.142 | 0.7259 |
| SECONDARY Annualized TKV Slope for Study 156-04-251 Placebo Participants Enrolled in Study 156-08-271 |
4.779; 5.627 | 0.1080 |
| SECONDARY Annualized Slope of Renal Function (eGFRCKD-EPI) for Study 156-04-251 Placebo Participants Enrolled in Study 156-08-271 |
-3.211; -3.572 | 0.2265 |
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.
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).
Data sourced from ClinicalTrials.gov (NCT01214421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.