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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
Details
| Lead sponsor | University of Oslo School of Pharmacy |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 298 |
| Start date | 2003-02 |
| Completion | 2007-02 |
Conditions
- Renal Transplantation
Interventions
- Mycophenolate mofetil withdrawal
- Cyclosporione A withdrawal
Primary outcomes
- 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.
Countries
Norway