Pathophysiology of Uric Acid Nephrolithiasis (IUAN)
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|ClinicalTrials.gov Identifier: NCT00904046|
Recruitment Status : Recruiting
First Posted : May 19, 2009
Last Update Posted : May 19, 2020
This study has two aims:
Aim 1: To determine the presence of accumulation of fat within cells and the functional consequences of this in the kidney by correlating kidney fat content with urine test results.
Aim 2: The investigators will evaluate the effect of thiazolidinedione (pioglitazone) on excess fatty acid accumulation in kidney tissue and its correlation with uric acid stone formation in subjects with uric acid stones.
Pioglitazone is already U.S. Food & Drug Administration (FDA)-approved for the treatment of type 2 diabetes, but is not approved by the FDA for treating or preventing or diagnosing stone risk.
|Condition or disease||Intervention/treatment||Phase|
|Uric Acid Kidney Stone Disease||Drug: Pioglitazone Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Pathophysiology of Uric Acid Nephrolithiasis|
|Actual Study Start Date :||September 5, 2019|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||December 2022|
For 60 Aim 2 Subjects Only - Pioglitazone (Actos)
30 mg orally daily for 6 months
Other Name: Thiazolidinedione
Placebo Comparator: Placebo
For 60 Subjects in Aim 2 Only - Placebo for Pioglitazone
Placebo taken orally once a day for 6 months.
- Reversal of renal lipotoxicity will occur with pioglitazone. [ Time Frame: 6 months ]
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): NCT00904046
|Contact: Ann Heard-Sakhaee, RN||214-648-4893||Ann.Heard-Sakhaee@UTSouthwestern.edu|
|Contact: Marsha Roberts, RN||214-648-0399||marsha.roberts@UTSouthwestern.edu|
|United States, Texas|
|UT Southwestern Medical Center - Center for Mineral Metabolism||Recruiting|
|Dallas, Texas, United States, 75390-8885|
|Principal Investigator:||Khashayar Sakhaee, MD||UT Southwestern|