Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months Posttransplant
|Renal Transplantation||Drug: Mycophenolate mofetil withdrawal Drug: Cyclosporione A withdrawal||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|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®)|
- The primary efficacy endpoint is the absolute change in renal function from inclusion to 12 months post drug withdrawal, evaluated as GFR estimated from Nankivell's formula B and normalised for 1.73 m2 body-surface.
- Graft and patient survival at 12 months and 5 years posttransplant.
- Proportion of patients with biopsy-proven acute rejection or acute rejection (biopsy proven + presumptive) episodes within 12 months.
- Incidence of HB, WBC, platelet abnormal values requiring clinical intervention within 12 months.
- Incidence of need for additional immunosuppressive therapy at 12 months.
- Absolute difference in renal function between treatment groups at 12 months, evaluated by Nankivell`s formula (B).
- Renal function (Nankivell`s formula B) development over time (3 monthly) between treatment groups within 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.
|Study Start Date:||February 2003|
|Study Completion Date:||February 2007|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148252
|Bergen, Norway, 5021|
|Lillehammer, Norway, 2609|
|Nordbyhagen, Norway, 1474|
|Rikshospitalet, Section of Nephrology|
|Oslo, Norway, 0027|
|Oslo, Norway, 0450|
|Skien, Norway, 3710|
|Sentralsykehuset i Rogaland|
|Stavanger, Norway, 4068|
|Tromsø, Norway, 9038|
|St. Olavs hospital|
|Trondheim, Norway, 7030|
|Study Director:||Anders Åsberg, MSc||University of Oslo|