Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment.

Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment. - ADPKD confirmatory study to establish the determinants of disease progression and response to tolvaptan treatment.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015245

Enrollment

100

Registered

2014-09-25

Start date

2014-09-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autosomal dominant polycystic kidney disease (ADPKD)

Interventions

tolvaptan 60~120mg/day tolvaptan less than 60mg/day (in case of minimize dose recommended, for example

kidney dysfunction) tolvaptan less than 60mg/day (in case of minimize dose recommended, for example

kidney dysfunction) no medication tolvaptan less than 60mg/day of start dose (in case of minimize start dose recommended, for example

less than 20 years old or more than 65 years old)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. ADPKD patient 2. total kidney volume is more than 750ml by CT or MRI, and also increased speed of total kidney volume is more than almost 5% per year. 3. The patient who was agreed informed consent.

Exclusion criteria

Exclusion criteria: (1) contraindicated patient of tolvaptan 1. patient who has past history of hypersensitivity to tolvaptan or similar compound (mozavaptan) 2. patient who is not able to feel thirst or is difficult to water intake. 3. hypernatremia 4. severe kidney dysfunction (eGFR less than 15mL/min/1.73m2) 5. present or past history of liver dysfunction by chronic hepatitis, or drug-induced liver dysfunction, excluding liver cyst in ADPKD 6. The pregnancy or the woman who may be pregnant. (2) The patient judged inappropriate by study responsibility doctor.

Design outcomes

Primary

Measure	Time frame
change of kidney function (eGFR)	—

Secondary

Measure	Time frame
total kidney volume urine concentration plasma AVP concentration urine cAMP incidence and severity of symptom related with ADPKD (urine concentration ability, hypertension, kidney pain, kidney function, hematuria, kidney stone, kidney infection)	—

Countries

Japan

Contacts

Public ContactToshio Mochizuki

Tokyo Women's Medical University Department of Nephrology

mtoshi@twmu.ac.jp0333538111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026