Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Conditions
Keywords
Autosomal dominant polycystic kidney disease
Brief summary
Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease
Interventions
DRUGTamibarotene
Subjects are administrated to tamibarotene 4 mg in daily for 52 weeks.
DRUGPlacebo
Subjects are administrated to placebo in daily for 52 weeks.
Sponsors
Rege Nephro Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
26 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in TKV from baseline | 52 Week after administration of Investigational Product | TKV |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in TLV from baseline | 52 Week after administration of Investigational Product | TLV |
| Changes in eGFR from baseline | 52 Week after administration of Investigational Product | eGFR |
| Incidence of adverse events | 1 year | Safety |
Countries
Japan
Outcome results
None listed