Study of Tamibarotene in Patients With ADPKD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-22

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Tamibarotene Group

Group Type ACTIVE_COMPARATOR

Tamibarotene

Intervention Type DRUG

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

Placebo Group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects are administrated to placebo in daily for 52 weeks.

Interventions

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Tamibarotene

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

Intervention Type DRUG

Placebo

Subjects are administrated to placebo in daily for 52 weeks.

Intervention Type DRUG

Eligibility Criteria

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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:

1. Female: From informed consent to 2 years after the last administration of the study drug
2. 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

Minimum Eligible Age

26 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No