Status:
TERMINATED
Rosiglitazone and Insulin Resistance in Renally Impaired Patients
Lead Sponsor:
Leiden University Medical Center
Conditions:
Chronic Kidney Disease
Insulin Resistance
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
30 non-diabetic, non-obese patients with stage 4 chronic kidney disease will be asked to participate in this metabolic study. The primary aim of this study is to determine the effect of rosiglitazone...
Detailed Description
This part of the study will be performed in 30 non-diabetic non-obese patients. In this study patients will receive single-dose oral placebo and rosiglitazone once daily to be taken in the morning. Du...
Eligibility Criteria
Inclusion
- CKD stage 4
- BMI ≤ 30
- Fasting glucose \< 7 mmol/l
Exclusion
- Exclusion of patients will take place in case of:
- A diagnosis of diabetes mellitus for which the patient uses insulin
- Significant co-morbidities which, according to the treating nephrologists, makes it unlikely that the patient will be able to complete the foreseen study period
- Significant cardiovascular co-morbidities which are likely to interfere with the objectives of the study (morbid obesity, family history of dyslipidemia, etc.); at the discretion of the treating nephrologists or the principal investigator
- Allergy for PPAR's
- Cardiac disease with marked limitation of functional capacity (New York Heart Association III or IV clinical status)
- Use of immunosuppressant agents
- History of renal transplant
- Hepatic insufficiency (defined as transaminase concentrations above \> 2.5 times the upper limit of normal for the laboratories)
- A history of alcohol abuse or excessive alcohol use defined as more than 21 consumptions per week
- For female patients: pregnancy, the intention to become pregnant within the study period, or lactating patients
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00452166
Start Date
April 1 2007
End Date
May 1 2008
Last Update
October 2 2008
Active Locations (1)
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1
LUMC
Leiden, Netherlands