Status:
TERMINATED
Metabolic Effects of Thiazolidinediones in Chronic Kidney Disease
Lead Sponsor:
Vanderbilt University
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The substantially increased cardiovascular morbidity and mortality rates in chronic kidney disease (CKD) patients cannot be sufficiently explained by traditional coronary risk factors. It is apparent ...
Eligibility Criteria
Inclusion
- Patients with Stage 3 or 4 chronic kidney disease as measured by a Modification in Diet in Renal Disease Study (MDRD) estimate of between 15 ml/min and 59 ml/min.
- Age between 18 and 75 years old.
- Patients without hospitalization for cardiac or infection related morbidity over the previous four weeks (due to the potential confounding effects on baseline study variables).
- Patients who are able to provide consent to participate in the study.
Exclusion
- Patients with prior documented diagnosis of diabetes mellitus.
- Patients with fasting blood glucose \> 110mg/dL.
- Prisoners, patients will significant mental illness, pregnant women, and other vulnerable populations.
- Patients with active hepatic disease and/or ALT \> 2.5 times upper limit of normal.
- Patients with history of congestive heart failure and NYHA Class III-IV symptoms at any time.
- Patients for whom living donor renal transplantation is already scheduled or in the process of being evaluated, as these patients will be unlikely to complete study protocols before transplantation.
- Patients with severe co-morbid conditions (eg, symptomatic hepatic cirrhosis, metastatic cancer, HIV infection with AIDS).
- Patient with active inflammatory process (eg., SLE, rheumatoid arthritis, gout) for which they are currently receiving immune modulating medications.
- Patients who are on corticosteroid therapy.
- Patients who do not consent to participate in the study.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00368017
Start Date
April 1 2006
End Date
September 1 2007
Last Update
November 3 2010
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232