PIOPKD Clinical Trial
Clinical trial to test the safety and efficacy of low dose (15 mg/day) pioglitazone (Actos) on ADPKD progression. Pioglitazone is currently used in clinical practice to treat diabetes. This is double-bind, 2 year cross-over study. Each volunteer will be on placebo for one year and pioglitazone for one year. Volunteers will be randomized as to whether the first year will be drug or placebo. Primary efficacy end point will be kidney volume by MRI.
Currently enrolling volunteers with ADPKD.
Indiana University School of Medicine, Indianapolis
- Male or female ADPKD patients aged 18-45
- eGFR (kidney function)_at or above 60 ml/min
- Normal liver enzyme (function) on blood tests
- Fasting blood sugar levels between 70 and 120
- For female patients, a willingness to use double contraception to avoid pregnancy while in study
- Able to give informed consent
- Abdominal discomfort or enlarged kidneys on previous tests
- Uncontrolled hypertension, defined as systolic > 150, diastolic > 90 despite an attempt by physician to titrate medications
- History of impaired heart function or heart disease
- Systemic illness requiring immunosuppressive or anti-inflammatory agents
- Congenital absence of a kidney or history of a total nephrectomy
- History of cyst reduction or partial nephrectomy
- History of renal cyst aspiration within the previous year
- History of bladder cancer, or blood in the urine
- Inability to undergo MRI due to implantable devices (for example, hip replacement) or foreign objects that preclude MRI
- Active renal transplant
- Allergy or sensitivity to any of the components of the test materials
- In nursing home or prison
- Currently pregnant or plans to become pregnant during the study
Visits will be at least every 3 months over two years with a possibility of additional checkups if abnormal blood tests are found.
You will be compensated $10 at each completed visit for parking and your time.
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