Indiana University Health
Indianapolis, Indiana, 46202, United States
NCT Number: NCT02697617
Funding Source - FDA OOPD
Pioglitazone is currently used in clinical practice to treat diabetes and this study will examine the potential use of a low dose of the same drug for the treatment of polycystic kidney disease. The purpose of this study is to determine whether the diabetes drug pioglitazone (Actos) is a safe and effective treatment of autosomal dominant polycystic kidney disease when treated in its early stages. Pioglitazone is approved by the FDA for the treatment of diabetes. Pre-clinical models of polycystic kidney disease have shown that low dose treatment with pioglitazone decreases the growth of the cysts. The studies also suggest that effective pioglitazone dosing for polycystic kidney disease may be lower than that used to treat diabetes. The purpose of this study is to see if pioglitazone might slow cyst disease in humans.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 2
Indianapolis, Indiana, 46202, United States
Patients will be randomize to placebo or 15 mg pioglitazone for 12 months, and then be crossed over to the other arm. Patients will undergo MRI of the liver and kidney and MRspectroscopy of the lumbar spine (if they choose as this is ancillary study) three times during the study. Assessments will be every 3 months and include blood work, blood pressure, and body water assessments.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pioglitazone
Other names: Actos
Placebo
Time frame: average of 4 measures in each 12 month arm
Bioimpedance analysis (BIA)(Ohms); Increase in BIA in Ohms indicates a decrease in total body water
Time frame: Baseline, end of year 1, and end of year 2
Change in total kidney volume by Magnetic Resonance Imaging (MRI) from beginning to end of the 12 months
Time frame: measured quarterly for 12 months in pioglitazone and same in placebo
number of patients with blood sugar < 70 mg/dl
Time frame: measured quarterly over 12 months for each arm
Number of patients with elevated liver test (ALT or AST) > 2 times upper limit of normal
Time frame: average of 4 values over 12 months
average estimated glomerular filtration rate by chronic kidney disease (CKD) epidemiologic (epi) formula measured quarterly
Time frame: average of 4 measures over 12 months
mean systolic and diastolic blood pressure
Time frame: Baseline, end of year 1, and end of year 2
We will assess change in bone marrow fat by MR spectroscopy as an ancillary study to be done at the same time as MRI; will not be done due to person leaving institution.
Indiana University
Other
Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney
Acronym: PIOPKD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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