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Study of the Biological and Physical Manifestations of Spontaneous Uric Acid Kidney Stone Disease (IUAN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by University of Texas Southwestern Medical Center
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Khashayar Sakhaee, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00904046
First received: May 15, 2009
Last updated: February 4, 2015
Last verified: February 2015
History of Changes
  Purpose

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.


Condition Intervention
Uric Acid Kidney Stone Disease
 Drug: Pioglitazone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Pathophysiology of Uric Acid Nephrolithiasis

Resource links provided by NLM:

MedlinePlus related topics: Kidney Stones
U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Reversal of renal lipotoxicity will occur with pioglitazone. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 60
Study Start Date: May 2009
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pioglitazone Drug: Pioglitazone
30 mg orally daily for 6 months
Other Name: Thiazolidinedione
Placebo Comparator: Placebo Drug: Placebo
Placebo taken orally once a day for 6 months.

  Eligibility
Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904046

Contacts
Contact: Ann Heard-Sakhaee, RN 214-648-4893 Ann.Heard-Sakhaee@UTSouthwestern.edu
Contact: Marsha Roberts, RN 214-648-0399 marsha.roberts@UTSouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center - Center for Mineral Metabolism Recruiting
Dallas, Texas, United States, 75390-8885
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Takeda Pharmaceuticals North America, Inc.
  More Information

Additional Information:
Center for Mineral Metabolism Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Khashayar Sakhaee, Professor of Internal Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00904046     History of Changes
Other Study ID Numbers: 1R01DK081423
Study First Received: May 15, 2009
Last Updated: February 4, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Uric acid
Nephrolithiasis

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Calculi
Kidney Diseases
 Pathological Conditions, Anatomical
Urinary Calculi
Urolithiasis
Urologic Diseases

ClinicalTrials.gov processed this record on March 02, 2015