Status:
COMPLETED
Pathogenesis of Uric Acid Nephrolithiasis: Role of Pioglitazone/Weight Loss
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Nephrolithiasis, Uric Acid
Eligibility:
All Genders
21-99 years
Phase:
PHASE4
Brief Summary
The investigators will randomize overweight and obese iuan patients to Pio (45 mg/day, highest approved dose or placebo), WL (10% of body weight, following the established program used in the Diabetes...
Detailed Description
In IUAN patients, the investigator will compare 1. PPAR activation; 2. weight loss; or 3. combination; on urine acid-base parameters relevant to UA stone risk. The investigator will assess the effect ...
Eligibility Criteria
Inclusion
- Idiopathic uric acid nephrolithiasis, with last stone analysis showing that stone has \>90% uric acid in composition Age \>21 years Any gender, race/ethnicity (from weight loss), but weight \<165 Kg (to fit into MR instrument); eGFR\>60ml/min/1.73 m2
Exclusion
- Bariatric surgery, chronic diarrhea, recurrent UTIs current insulin use use of a thiazolidinedione in past 2 years contraindication to thiazolidinedione use (liver dz, pedal edema, CHF NYHA class III/IV, no contraception) Bladder cancer Use of SGLT2-i, GLP-1 analogs, gemfibrozil, topiramate, rifampin Hba1c \> 8.5%
Key Trial Info
Start Date :
October 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2025
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04370093
Start Date
October 17 2019
End Date
May 28 2025
Last Update
September 9 2025
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9107