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Active, Not Recruiting

NCT Number: NCT06289998

Study of Tamibarotene in Patients With ADPKD

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD) Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

26 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kurume University Hospital, Kurume, Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Tamibarotene

Drug

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

Placebo

Drug

Subjects are administrated to placebo in daily for 52 weeks.

Primary outcomes

  1. Changes in TKV from baseline

    Time frame: 52 Week after administration of Investigational Product

    TKV

Secondary outcomes

  1. Changes in TLV from baseline

    Time frame: 52 Week after administration of Investigational Product

    TLV

  2. Changes in eGFR from baseline

    Time frame: 52 Week after administration of Investigational Product

    eGFR

  3. Incidence of adverse events

    Time frame: 1 year

    Safety

Sponsors and collaborators

Lead sponsor

Rege Nephro Co., Ltd.

Industry

Registry information

Official study title

Phase IIa Clinical Trial of Tamibarotene in Patients With Autosomal Dominant Polycystic Kidney Disease

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2024
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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