Pathophysiology of Uric Acid Nephrolithiasis (IUAN)
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ClinicalTrials.gov Identifier: NCT00904046 |
Recruitment Status
:
Recruiting
First Posted
: May 19, 2009
Last Update Posted
: October 31, 2016
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Uric Acid Kidney Stone Disease | Drug: Pioglitazone Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | Pathophysiology of Uric Acid Nephrolithiasis |
Study Start Date : | May 2009 |
Estimated Primary Completion Date : | April 2019 |
Estimated Study Completion Date : | December 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Pioglitazone
For 60 Aim 2 Subjects Only - Pioglitazone (Actos)
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Drug: Pioglitazone
30 mg orally daily for 6 months
Other Name: Thiazolidinedione
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Placebo Comparator: Placebo
For 60 Subjects in Aim 2 Only - Placebo for Pioglitazone
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Drug: Placebo
Placebo taken orally once a day for 6 months.
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- Reversal of renal lipotoxicity will occur with pioglitazone. [ Time Frame: 6 months ]

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Ages Eligible for Study: | 21 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904046
Contact: Ann Heard-Sakhaee, RN | 214-648-4893 | Ann.Heard-Sakhaee@UTSouthwestern.edu | |
Contact: Marsha Roberts, RN | 214-648-0399 | marsha.roberts@UTSouthwestern.edu |
United States, Texas | |
UT Southwestern Medical Center - Center for Mineral Metabolism | Recruiting |
Dallas, Texas, United States, 75390-8885 |
Principal Investigator: | Khashayar Sakhaee, MD | UT Southwestern |
Additional Information:
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: |
00000125 - 856 1R01DK081423 ( U.S. NIH Grant/Contract ) |
First Posted: | May 19, 2009 Key Record Dates |
Last Update Posted: | October 31, 2016 |
Last Verified: | October 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Khashayar Sakhaee, University of Texas Southwestern Medical Center:
Uric acid Nephrolithiasis |
Additional relevant MeSH terms:
Kidney Calculi Nephrolithiasis Kidney Diseases Urologic Diseases Urolithiasis Urinary Calculi Calculi Pathological Conditions, Anatomical |
Pioglitazone Uric Acid Hypoglycemic Agents Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |