18 and older, any sex, with Polycystic Kidney, Autosomal Dominant. 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.
Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)Primary· Baseline through end of treatment (up to 42 months) and follow-up 7 days posttreatment(+ 7 days)
An adverse event (AE) was as any untoward medical occurrence associated with the use of an investigational medicinal product (IMP), whether or not considered IMP related. A TEAE was an AE that started after trial drug treatment; or if the event was continuous from baseline and was serious, related to IMP, or resulted in death, discontinuation, interruption or reduction of trial therapy. A serious TEAE included any event that resulted in: death, life-threatening, persistent or significant incapacity, substantial disruption of ability to conduct normal life functions, required inpatient hospital
Participants with TEAEs
Group
Value
95% CI
Tolvaptan (From 156-13-210: Tolvaptan)
473
Tolvaptan (From 156-13-210: Placebo)
531
Tolvaptan (From 156-08-271: Tolvaptan)
640
Tolvaptan (From Other: Tolvaptan)
6
Tolvaptan (From Other: Placebo)
3
Participants with serious TEAEs
Group
Value
95% CI
Tolvaptan (From 156-13-210: Tolvaptan)
87
Tolvaptan (From 156-13-210: Placebo)
96
Tolvaptan (From 156-08-271: Tolvaptan)
103
Tolvaptan (From Other: Tolvaptan)
1
Tolvaptan (From Other: Placebo)
2
Participants with severe TEAEs
Group
Value
95% CI
Tolvaptan (From 156-13-210: Tolvaptan)
74
Tolvaptan (From 156-13-210: Placebo)
78
Tolvaptan (From 156-08-271: Tolvaptan)
83
Tolvaptan (From Other: Tolvaptan)
2
Tolvaptan (From Other: Placebo)
1
Discontinued due to TEAEs
Group
Value
95% CI
Tolvaptan (From 156-13-210: Tolvaptan)
33
Tolvaptan (From 156-13-210: Placebo)
65
Tolvaptan (From 156-08-271: Tolvaptan)
38
Tolvaptan (From Other: Tolvaptan)
0
Tolvaptan (From Other: Placebo)
1
Deaths
Group
Value
95% CI
Tolvaptan (From 156-13-210: Tolvaptan)
1
Tolvaptan (From 156-13-210: Placebo)
5
Tolvaptan (From 156-08-271: Tolvaptan)
3
Tolvaptan (From Other: Tolvaptan)
0
Tolvaptan (From Other: Placebo)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline through end of treatment (up to 42 months) and follow-up 7 days posttreatment (+ 7 days).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
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 Polycystic Kidney, Autosomal Dominant
Currently open trials in the same condition.
NCT07280585 — STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease
· Phase 3
· recruiting
NCT05510115 — Feasibility of Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease
· Phase 2
· active not recruiting
Other Otsuka Pharmaceutical Development & Commercialization, Inc. trials
Trials by the same sponsor.
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· Phase 1
· not yet recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva
· Phase 1
· recruiting
NCT07455084 — A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
· Phase 1
· not yet recruiting
NCT07314333 — A Trial to Assess How Centanafadine Interacts With Stimulants in the Body
· Phase 1
· recruiting
NCT07329621 — A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy Male Adults
· Phase 1
· recruiting
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: 27 November 2019
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/NCT02251275.