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A Controlled Randomized Open-label Multicenter Study Evaluating if Early Conversion to Everolimus (Certican) From Cyclosporine (Neoral) in de Novo Renal Transplant Recipients Can Improve Long-term Renal Function and Slow Down the Progression of Chronic Allograft Nephropathy
This study is designed to evaluate if early conversion to everolimus from cyclosporine in de novo renal transplant recipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy
Details
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 204 |
| Start date | 2008-03 |
| Completion | 2013-05 |
Conditions
- Renal Function
Interventions
- everolimus
- cyclosporine A
- Enteric Coated Mycophenolate Sodium (EC-MPS)
- corticosteroids
- Basiliximab
Primary outcomes
- Measured Glomerular Filtration Rate — Month 12
To compare the efficacy between treatment regimens by assessing the difference in renal function evaluated by mean measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX). The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice.
Countries
Denmark, Norway, Sweden