NCT00148252

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

Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months Posttransplant - Randomised Withdrawal of Mycophenolate Mofetil (CellCept®) or Cyclosporine A (Sandimmun Neoral®)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 298 (planned)
• Sponsor: University of Oslo School of Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Mycophenolate mofetil withdrawal
DRUG	Cyclosporione A withdrawal

Timeline

• Start date: 2003-02-01
• Primary completion: 2005-11-01
• Completion: 2007-02-01
• First posted: 2005-09-07
• Last updated: 2012-06-07

Locations

9 sites across 1 country: Norway