Clinical trial NCT06289998: Study of Tamibarotene in Patients With ADPKD
Official title: Phase IIa Clinical Trial of Tamibarotene in Patients With Autosomal Dominant Polycystic Kidney Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Keywords: Autosomal dominant polycystic kidney disease
Lead sponsor: Rege Nephro Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-04
Enrollment: 70
Sex: ALL
Minimum age (years): 26
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Changes in TKV from baseline
timeFrame: 52 Week after administration of Investigational Product
Secondary outcomes:
measure: Changes in TLV from baseline
timeFrame: 52 Week after administration of Investigational Product
measure: Changes in eGFR from baseline
timeFrame: 52 Week after administration of Investigational Product
measure: Incidence of adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Kawasaki
country: Japan
facility: Toranomon Hospital Kajigaya
state: Kanagawa
city: Bunkyo-ku
country: Japan
facility: Juntendo University School of Medicine Juntendo Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Shinjukuku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Kyoto
country: Japan
facility: Kyoto University Hospital
Study officials:
References: