Pathophysiology of Uric Acid Nephrolithiasis

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Takeda Pharmaceuticals North America, Inc.
• Treatments: 2,4-thiazolidinedione; Pioglitazone; Uric Acid

Criteria

Inclusion Criteria:

• Subjects with uric acid kidney stone disease

• Age > 21 years

Exclusion Criteria:

• Body weight> 350 lb

• Chronic alcohol use

• Chronic liver disease

• Chronic renal disease

• Anemia

• Contraindication to pioglitazone use:

• history of congestive heart failure NYHA class III or IV

• significant pedal edema

• liver failure

• not willing to practice an effective contraception for the duration of the study

• Thiazolidinedione use in the preceding 18 months