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 December 2015 by University of Texas Southwestern Medical Center
Sponsor:
University of Texas Southwestern Medical Center
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: December 11, 2015
Last verified: December 2015
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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:
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 to 99 Years (Adult, Senior) |
| 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
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
| 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: | December 11, 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 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 |
ClinicalTrials.gov processed this record on September 30, 2016