Renal Transplantation Clinical Trial
Official title:
Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months Posttransplant - Randomised Withdrawal of Mycophenolate Mofetil (CellCept®) or Cyclosporine A (Sandimmun Neoral®)
To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy
To compare the change in renal function between CsA or MMF withdrawal from before to 12
months after drug withdrawal in renal transplant recipients on triple immunosuppressive
therapy.
Secondly to examine safety following withdrawal of CsA or MMF, respectively, by the
following parameters:
- Biopsy verified acute rejection episodes, time to first rejection and number of steroid
resistant rejection episodes within 12 months.
- Hematology (Hb, WBC, platelets) abnormalities within 12 months.
- Graft and patient survival at 12 months and 5 years. Absolute difference in renal
function between withdrawal groups at 12 months. Three monthly changes in renal
function from drug withdrawal to 12 months. Change in dyslipidemia frequency from drug
withdrawal to 12 months. Change in hypertension frequency from drug withdrawal to 12
months. Change in glucose tolerance from drug withdrawal to 12 months. Cumulative
incidence of clinical infections resulting in hospitalization within 12 months.
Sub protocols will also examine the following aspects:
Cardiovascular: Homocysteine. Lipid peroxidation. Microvascular function and vasoactive
parameters Quality of life (QoL): ESRD SCL-TM, SF-36 (short version) and EQ-5D (GI-checklist
extended) questionnaires will be used.
Pharmacoeconomical evaluation.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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