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Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months Posttransplant

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®)

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00148252
Study type Interventional
Source University of Oslo School of Pharmacy
Contact
Status Terminated
Phase Phase 4
Start date February 2003
Completion date February 2007
View Details
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