Who is sponsoring NCT03949894?

NCT03949894 is sponsored by Korea Otsuka Pharmaceutical Co., Ltd..

What drugs are being tested in NCT03949894?

Interventions in NCT03949894: Tolvaptan.

What condition does NCT03949894 study?

NCT03949894 studies Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Is NCT03949894 still recruiting?

NCT03949894 is currently completed. Last updated 16 June 2022.

Last reviewed 2022-06-16 · How we verify

NCT03949894: ESSENTIAL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease

Completed Phase 4 Last updated 16 June 2022

What this trial tests

Phase 4 trial testing Tolvaptan in Autosomal Dominant Polycystic Kidney Disease (ADPKD) in 118 participants. Completed in 25 May 2022.

Timeline

1 July 2019

Primary endpoint
25 May 2022

25 May 2022

Quick facts

Lead sponsor	Korea Otsuka Pharmaceutical Co., Ltd.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	118
Start date	1 July 2019
Primary completion	25 May 2022
Estimated completion	25 May 2022
Sites	18 locations across South Korea

Drugs / interventions tested

Tolvaptan (TOLVAPTAN) — full drug profile →

Conditions studied

Autosomal Dominant Polycystic Kidney Disease (ADPKD) — all drugs for Autosomal Dominant Polycystic Kidney Disease (ADPKD) →

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 19 to 50, any sex, with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the safety and therapeutic effectiveness of tolvaptan when administered to slow the progression of cyst development and renal function insufficiency in adult Korean patients diagnosed with rapidly progressive ADPKD who have chronic kidney disease (CKD) stages 1-3 at initiation of treatment.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Experimental Models of Polycystic Kidney Disease: Applications and Therapeutic Testing.
Sieben CJ, Harris PC. · · 2023 · cited 23× · PMID 37418622 · DOI 10.34067/kid.0000000000000209
Clinical and genetic characteristics of Korean autosomal dominant polycystic kidney disease patients.
Oh YK, Park HC, Ryu H, Kim YC, et al · · 2021 · cited 12× · PMID 34237823 · DOI 10.3904/kjim.2021.176
Evaluating the Safety and effectivenesS in adult KorEaN patients treated with Tolvaptan for management of autosomal domInAnt poLycystic kidney disease (ESSENTIAL): short-term outcomes during the titration period.
Huh H, Kim YS, Chung W, Kim YL, et al · · 2023 · cited 2× · PMID 36634967 · DOI 10.23876/j.krcp.22.024

Verify or expand the search:

Other trials of Tolvaptan

Trials testing the same drug.

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
NCT03764605 — Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease · Phase 3 · unknown
NCT03541447 — Tolvaptan-Octreotide LAR Combination in ADPKD · Phase 2 · completed

Other recruiting trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Currently open trials in the same condition.

NCT07161037 — Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW) · Phase 2 · recruiting
NCT06747572 — Polycystic Kidney Disease 1 (PKD1) Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease · active not recruiting
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 Korea Otsuka Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT06674291 — Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive M · not yet recruiting
NCT05048069 — Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab. · unknown
NCT04189705 — A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis · Phase 3 · completed
NCT04150146 — To Evaluate Food Effect on the Pharmacokinetics of Rebamipide in Healthy Volunteers · Phase 1 · completed
NCT04150172 — To Evaluate Pharmacokinetics and Safety of Two Different Formulation of Rebamipide in Healthy Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03949894 (US National Library of Medicine, public domain)
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 Korea Otsuka Pharmaceutical Co., Ltd.
Last refreshed: 16 June 2022

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/NCT03949894.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing