Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney Disease (PIOPKD)
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|ClinicalTrials.gov Identifier: NCT02697617|
Recruitment Status : Active, not recruiting
First Posted : March 3, 2016
Last Update Posted : February 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Kidney Disease||Drug: Pioglitazone Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney|
|Actual Study Start Date :||January 26, 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2020|
Placebo Comparator: Placebo Arm
Subject will be on placebo
Active Comparator: Pioglitazone Arm
Subject will be on pioglitazone
Other Name: Actos
- To provide information on the safety of pioglitazone therapy in human ADPKD patients over a one year period assessed by edema, tolerance of drug, hematuria, and blood sugar levels. [ Time Frame: Quarterly (every 4 months) until the end of the study (predicted study end date is 12/31/2019) ]Assessment of edema, tolerance of drug, hematuria, and blood sugar levels.
- To provide information on the efficacy of pioglitazone therapy in human ADPKD patients over a one year period using MRI monitoring of total kidney volume. [ Time Frame: Baseline, end of year 1, and end of year 2 ]We will assess change in kidney volume by MRI, change in liver volume by MRI.
- To provide information on bone marrow fat content [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697617
|United States, Indiana|
|Indiana University Health|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Sharon Moe, 317-944-7580||Indiana University|