Pathophysiology of Uric Acid Nephrolithiasis

NCT00904046 | Completed DMC

• 2 other identifiers: Study000001251R01DK081423
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uric Acid Kidney Stone Disease

Keywords

Uric acid; Nephrolithiasis

Outcome Measures

Primary Outcomes (1)

• Reversal of renal lipotoxicity will occur with pioglitazone.

  6 months

Study Arms (2)

Pioglitazone

EXPERIMENTAL

For 60 Aim 2 Subjects Only - Pioglitazone (Actos)

Drug: Pioglitazone

Placebo

PLACEBO COMPARATOR

For 60 Subjects in Aim 2 Only - Placebo for Pioglitazone

Drug: Placebo

Interventions

Pioglitazone DRUG

30 mg orally daily for 6 months

Also known as: Thiazolidinedione

Pioglitazone

Placebo DRUG

Placebo taken orally once a day for 6 months.

Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects with uric acid kidney stone disease
• Age \> 21 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

UT Southwestern Medical Center - Center for Mineral Metabolism

Dallas, Texas, 75390-8885, United States

Location

Related Links

• Center for Mineral Metabolism Website

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Pioglitazone; 2,4-thiazolidinedione

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

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 19, 2009
• Study Start: January 15, 2010
• Primary Completion: November 16, 2017
• Study Completion: November 16, 2017
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)