NCT02697617

Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney Disease

Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Polycystic Kidney Disease

Interventions

Type	Name	Description
DRUG	Pioglitazone	Pioglitazone
DRUG	Placebo	Placebo

Timeline

• Start date: 2016-01-26
• Primary completion: 2019-10-01
• Completion: 2020-01-01
• First posted: 2016-03-03
• Last updated: 2021-01-15
• Results posted: 2021-01-15

Locations

1 site across 1 country: United States