CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Pioglitazone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02697617
NCT02697617Phase 2Completed

Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney

Indiana University·interventional·Posted Mar 3, 2016·Updated Jan 15, 2021

In Brief

A Phase 2 clinical trial evaluating Pioglitazone and Placebo for Polycystic Kidney Disease. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 3, 2016
Enrollment StartJan 26, 2016
Primary CompletionOct 1, 2019
Study CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 10.3 years ago

Interventions

Pioglitazonedrug

Pioglitazone

Placebodrug

Placebo