Status:
COMPLETED
Metabolic and Renal Effects of Rosiglitazone in Kidney Transplant
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Kidney Transplant
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Abnormalities in glucidic and lipidic metabolism are common features in renal transplant patients on chronic immunossupression with steroids and calcineurin inhibitors. In kidney transplant patients w...
Detailed Description
INTRODUCTION Decreased insulin sensitivity, impaired glucose tolerance and dyslipidemia are common features in renal transplant patients on chronic immunosuppression with steroids and calcineurine inh...
Eligibility Criteria
Inclusion
- age: 18-70 years old
- kidney transplant since at least six months
- serum creatinine ≤ 3mg/dl without dialysis requirement
- serum creatinine changes ≤ + 30 % over the last three months
- overnight urinary albumin excretion rate ≥20µg/min
- well controlled hypertension (systolic/diastolic blood pressure \<150/90 mmHg)
- concomitant treatment with inhibitors of the renin angiotensin system (RAS) since at least six months
- effective contraception
- written informed consent
- legal capacity
Exclusion
- acute graft rejection over the last six months
- immunosuppressive therapy with FK506
- evidence of previous or concomitant liver disease and abnormal liver transaminases over the last six months
- evidence of heart failure (NYHA class II or more) or fluid overload
- overt diabetes or concomitant treatment with oral antidiabetic agents and/or insulin
- specific contraindication to the study drug
- legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00309309
Start Date
April 1 2005
End Date
July 1 2007
Last Update
July 3 2007
Active Locations (1)
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1
Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020