18 and older, any sex, with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Change From the Baseline in Total Kidney Volume (TKV) for Study 156-04-251 Participants Enrolled in This Study (156-08-271)Primary· Study Baseline (Prior to Day 1 in Study 156-04-251) to Month 24 in this study (Study 156-08-271)
Total kidney volume is a measure of disease progression in the ADPKD participants. Kidney volume was assessed in T1-weighted magnetic resonance images collected at each study site and sent to a central reviewing facility. At the central reviewing facility, radiologists used proprietary software to measure the volume of both kidneys in participants continuing from previous study (156-04-251) at Month 24 of this study (156-08-271) comparing change in TKV for the early-treated (those previously treated with tolvaptan) to delayed-treated (those previously treated with placebo). The percent change
Group
Value
95% CI
Tolvaptan, Early Treated (From Study 156-04-251: Tolvaptan)
28.66
± 26.14
Tolvaptan, Delayed Treated (From Study 156-04-251: Placebo)
30.58
± 27.21
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)Secondary· Study Baseline (Prior to Day 1 in Study 156-04-251) to Month 24 in this study (Study 156-08-271)
Estimated Glomerular Filtration Rate (eGFR) according to CKD-EPI is calculated using the CKD-EPI equation, expressed as a single equation, is GFR = 141 × min (serum creatinine \[Scr\]/κ, 1)α × max(Scr/κ, 1)\^-1.209 × 0.993 Age × 1.018 (if female) × 1.159 (if black), where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/ĸ or 1, and max indicates the maximum of Scr/κ or 1 in participants continuing from previous study (156-04-251) at Month 24 of this study (156-08-271) comparing change in eGFR for the
Group
Value
95% CI
Tolvaptan, Early Treated (From Study 156-04-251: Tolvaptan)
-16.77
± 13.16
Tolvaptan, Delayed Treated (From Study 156-04-251: Placebo)
-19.92
± 16.40
Annualized Slope of Total Kidney Volume (TKV) for Study 156-04-251 Participants Enrolled in Study 156-08-271Secondary· Study Baseline (Prior to Day 1 in Study 156-08-271) to Month 24 in this study (Study 156-08-271)
Annualized slope of TKV is a measure of renal function and disease progression in ADPKD participants. The annualized slope is calculated as percentage of growth in TKV (measured in mL by MRI) divided by each participant's years of participation for all participants was calculated using MMRM analysis in participants continuing from previous study (156-04-251) at Month 24 of this study (156-08-271) comparing annualized slope of TKV for the early-treated (those previously treated with tolvaptan) to delayed-treated (those previously treated with placebo). This outcome measure was analyzed only in
Group
Value
95% CI
Tolvaptan, Early Treated (From Study 156-04-251: Tolvaptan)
6.164
Tolvaptan, Delayed Treated (From Study 156-04-251: Placebo)
4.960
Annualized Slope of eGFR (CKD-EPI) for Study 156-04-251 Participants Enrolled in Study 156-08-271Secondary· Study Baseline (Prior to Day 1 in Study 156-08-271) to Month 24 (Study 156-08-271)
Annualized slope of eGFR (CKD-EPI) is a measure of renal function and disease progression in ADPKD participants. The annualized slope of eGFR (CKD-EPI) (divided by each participant's years of participation) for all participants was calculated using MMRM analysis in participants continuing from previous study (156-04-251) at Month 24 of this study (156-08-271) comparing change in TKV for the early-treated (those previously treated with tolvaptan) to delayed-treated (those previously treated with placebo). eGFR was calculated using the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula. This
Group
Value
95% CI
Tolvaptan, Early Treated (From Study 156-04-251: Tolvaptan)
-3.255
Tolvaptan, Delayed Treated (From Study 156-04-251: Placebo)
-3.142
Annualized TKV Slope for Study 156-04-251 Placebo Participants Enrolled in Study 156-08-271Secondary· Tolvaptan, Delayed Treated: Baseline to Month 24 in Study 156-08-271; Placebo: Baseline to Month 36 in Study 156-04-251
Annualized slope of TKV is a measure of renal function and disease progression in ADPKD participants. The annualized slope is calculated as percentage of growth in TKV (measured in mL by MRI) divided by each participant's years of participation, using MMRM analysis to compare annualized slope of TKV for the participants who received placebo in previous study (156-04-251) to annualized slope of TKV for the same participants who received tolvaptan in this study (156-08-271). This outcome measure was analyzed only in the participants enrolled from the previous study - 156-04-251 and who received
Group
Value
95% CI
Tolvaptan, Delayed Treated (In Study 156-08-271)
4.779
Placebo (In Study 156-04-251)
5.627
Annualized Slope of Renal Function (eGFRCKD-EPI) for Study 156-04-251 Placebo Participants Enrolled in Study 156-08-271Secondary· Tolvaptan, Delayed Treated: Baseline to Month 24 in Study 156-08-271; Placebo: Baseline to Month 36 in Study 156-04-251
Annualized slope of eGFR (CKD-EPI) is a measure of renal function and disease progression in ADPKD participants. The annualized slope of eGFR (calculated using CKD-EPI formula) divided by each participant's years of participation, using MMRM analysis to compare annualized slope of eGFR (CKD-EPI) for the participants who received placebo in previous study (156-04-251) to the annualized slope of eGFR (CKD-EPI) for the same participants who received tolvaptan in this study (156-08-271). This outcome measure was analyzed only in the participants enrolled from the previous study - 156-04-251 who re
Group
Value
95% CI
Tolvaptan, Delayed Treated (In Study 156-08-271)
-3.211
Placebo (In Study 156-04-251)
-3.572
Adverse events — posted to ClinicalTrials.gov
Time frame: From the signing of the informed consent form until the end of the study regardless of whether the participants were on or off active study medication (Up to approximately 5 years).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Tolvaptan (From Study 156-04-251: Tolvaptan, Early Treated)
Serious: 143/557 (26%)
Deaths: 5/557
Tolvaptan (From Study 156-04-251: Placebo, Delayed Treated)
Serious: 79/314 (25%)
Deaths: 0/314
Tolvaptan (From Other Studies: Tolvaptan, Early Treated)
Serious: 34/181 (19%)
Deaths: 0/181
Tolvaptan (From Other Studies: Placebo, Delayed Treated)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06506994 — A Study of HRS-9057 in Patients With Heart Failure and Volume Overload
· Phase 1
· completed
NCT06171100 — Low-dose Tolvaptan for Inpatient Hyponatraemia.
· unknown
NCT05569655 — Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With RHF Caused by PAH
· NA
· unknown
NCT03949894 — Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domI
· Phase 4
· completed
NCT03764605 — Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease
· Phase 3
· unknown
Other recruiting trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Currently open trials in the same condition.
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· recruiting
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NCT07355114 — Robotic vs Open Nephrectomy for ADPKD
· active not recruiting
NCT07535385 — RADIOLOGICAL AND CLINICAL EVALUATION OF RENAL EMBOLIZATION USING EVOH IN DIALYSIS PATIENTS WITH AUTOSOMAL DOMINANT POLYC
· recruiting
Other Otsuka Pharmaceutical Development & Commercialization, Inc. trials
Trials by the same sponsor.
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NCT07314333 — A Trial to Assess How Centanafadine Interacts With Stimulants in the Body
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc.
Last refreshed: 25 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01214421.