Study of Tamibarotene in Patients With ADPKD

NCT06289998 | Active Not Recruiting Phase 2

• 1 other identifier: RP014-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 8

Brief Summary

Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Keywords

Autosomal dominant polycystic kidney disease

Outcome Measures

Primary Outcomes (1)

• Changes in TKV from baseline

  TKV

  52 Week after administration of Investigational Product

Secondary Outcomes (3)

• Changes in TLV from baseline

  52 Week after administration of Investigational Product

• Changes in eGFR from baseline

  52 Week after administration of Investigational Product

• Incidence of adverse events

  1 year

Study Arms (2)

Tamibarotene Group

ACTIVE COMPARATOR

Drug: Tamibarotene

Placebo Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tamibarotene DRUG

Subjects are administrated to tamibarotene 4 mg in daily for 52 weeks.

Tamibarotene Group

Placebo DRUG

Subjects are administrated to placebo in daily for 52 weeks.

Placebo Group

Eligibility Criteria

• Age: 26 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed as ADPKD by modified Pei-Ravine
• eGFR(CKD-EPI) is equal to or greater than 60 mL/min/1.73m\^2
• Patients who are judged to be hard to treat with tolvaptan or who do not wish to be treated with tolvaptan, at the time of obtaining consent
• Patients with systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg. For patients receiving angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists, the dose must be constant for at least 6 weeks before obtaining informed consent

You may not qualify if:

• Women who are pregnant or may be pregnant
• Nursing mother
• Females with childbearing potential or male subjects with a fertile partner who is unable to use contraception for the following periods:
• Female: From informed consent to 2 years after the last administration of the study drug
• Male: From informed consent to 6 months after the last administration of the study drug
• Patients within 12 weeks from the last dose of a drug that affects renal cysts, such as tolvaptan, to the first dose of the study drug
• Patients with complications of intracranial aneurysm, malignant tumor, uncontrolled diabetes, osteoporosis, uncontrolled dyslipidemia, or abnormal liver function

Sponsors & Collaborators

• Rege Nephro Co., Ltd.: lead

Study Sites (8)

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, 247-8533, Japan

Location

Toranomon Hospital Kajigaya

Kawasaki, Kanagawa, 213-8587, Japan

Location

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

Juntendo University School of Medicine Juntendo Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Toranomon Hospital

Minato-ku, Tokyo, 105-8470, Japan

Location

Tokyo Women's Medical University Hospital

Shinjukuku, Tokyo, 162-8666, Japan

Location

Related Publications (1)

• St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

  PMID: 39356039 DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Interventions

tamibarotene

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 4, 2024
• Study Start: December 22, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (8)