Study of Tamibarotene in Patients With ADPKD

Rege Nephro

Status and phase

Active, not recruiting

Phase 2

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Treatments

Drug: Tamibarotene

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

RP014-01

Details and patient eligibility

About

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

Enrollment

70 estimated patients

Sex

All

Ages

26 to 55 years old

Volunteers

No Healthy Volunteers

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