drugset / Trial / NCT04370093

Pathogenesis of Uric Acid Nephrolithiasis: Role of Pioglitazone/Weight Loss

NCT04370093

Phase 4 Completed 29 enrolled University of Texas Southwestern Medical Center
RandomizedParallel-groupTriple-blindBasic science

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 Prevention Program), or Pio+WL. Participants will be evaluated at baseline and after 24 weeks of intervention while on a fixed metabolic diet to exclude the confounding effects of diet and perspiration. The primary endpoint will be change in upH, and multiple additional endpoints (serum, urine, imaging) will be assessed.

Timeline

Start
2019-10-17
Primary completion
2025-05-28
Completion
2025-05-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Pioglitazone Small molecule 45 mg

Indications