Phase IIa Clinical Trial of Tamibarotene in Patients With Autosomal Dominant Polycystic Kidney Disease
Tamibarotene
+ Placebo
Congenital Abnormalities+11
+ Abnormalities, Multiple
+ Ciliopathies
Treatment Study
Summary
Study start date: December 22, 2023
Actual date on which the first participant was enrolled.This clinical trial is focused on testing the safety and effectiveness of a drug called tamibarotene for individuals with Autosomal Dominant Polycystic Kidney Disease (ADPKD). ADPKD is a genetic disorder that causes numerous cysts to grow in the kidneys, potentially leading to kidney failure. The study aims to determine if tamibarotene can be a beneficial treatment option for managing this condition. Finding effective treatments is crucial for improving the quality of life for those affected by ADPKD and potentially slowing the progression of kidney damage. Participants in the trial will receive tamibarotene, though the specific method of administration is not detailed. The study is designed to observe how well the drug works and if it is safe for patients with ADPKD. Researchers will monitor patients for any changes in their condition and side effects to assess the overall impact of the treatment. Through these observations, the study seeks to gather valuable data on the therapeutic potential of tamibarotene for managing ADPKD.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.70 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 26 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 8 locations
Hokkaido University Hospital
Sapporo, JapanShonan Kamakura General Hospital
Kamakura, JapanToranomon Hospital Kajigaya
Kawasaki, Japan