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

NCT04370093 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: STU-2019-0907
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Nephrolithiasis, Uric Acid

Keywords

Biomedical Sciences

Outcome Measures

Primary Outcomes (1)

• Urine pH

  24-hour urine pH is the main determinant of uric acid stone formation and recurrence.

  24 weeks

Secondary Outcomes (3)

• Urine Ammonium/Net Acid Excretion

  24 weeks

• Urine Net Acid Excretion/Sulphate

  24 weeks

• Supersaturation Index of Uric Acid

  24 weeks

Study Arms (3)

Pioglitazone Drug (including Placebo)

EXPERIMENTAL

45 mg/day- one pioglitazone tablet once daily throughout the 24 weeks of the study

Drug: Pioglitazone 45 mg

Weight Loss, Behavioral

EXPERIMENTAL

Weight loss following the Group Lifestyle Balance Program based on the Diabetes Prevention Program that utilizes cognitive behavioral strategies (goal setting, problem solving, self-monitoring, stimulus control),and provides written education materials to support health and nutrition behavior changes for weight management and disease prevention.

Behavioral: Weight Loss

Pioglitazone + Weight Loss

OTHER

Pioglitazone 45 mg/day + Weight Loss following the Group Lifestyle Balance Program based on the Diabetes Prevention Program that utilizes cognitive behavioral strategies (goal setting, problem solving, self-monitoring, stimulus control),and provides written education materials to support health and nutrition behavior changes for weight management and disease prevention.

Other: Pioglitazone + Weight Loss

Interventions

Pioglitazone 45 mg DRUG

45 mg/day- one pioglitazone tablet once daily throughout the 24 weeks of the study

Pioglitazone Drug (including Placebo)

Weight Loss BEHAVIORAL

Weight loss following the Group Lifestyle Balance Program based on the Diabetes Prevention Program that utilizes cognitive behavioral strategies (goal setting, problem solving, self-monitoring, stimulus control),and provides written education materials to support health and nutrition behavior changes for weight management and disease prevention.

Weight Loss, Behavioral

Pioglitazone + Weight Loss OTHER

Pioglitazone + Weight loss following the Group Lifestyle Balance Program based on the Diabetes Prevention Program that utilizes cognitive behavioral strategies (goal setting, problem solving, self-monitoring, stimulus control),and provides written education materials to support health and nutrition behavior changes for weight management and disease prevention.

Pioglitazone + Weight Loss

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9107, United States

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Khashayar Sakhaee, MD

  UTSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 30, 2020
• Study Start: October 17, 2019
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

US (1)