Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program
Phase 4
Terminated
- Conditions
- Renal Transplantation
- Interventions
- Drug: Enteric Coated Mycophenolic Acid (MPA)Drug: Corticosteroids
- Registration Number
- NCT00956293
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study wants to address whether a calcineurin-inhibitor (CNI)-free regimen six weeks after transplantation for Eurotransplant Senior Program (ESP) patients is as safe and well tolerated as standard treatment but optimizing immunosuppressive therapy with benefits in renal function, new-onset diabetes mellitus, cardiovascular risk, cancer and allograft nephropathy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 207
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Basiliximab During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA. Control group Enteric Coated Mycophenolic Acid (MPA) During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA. Control group Corticosteroids During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA. Everolimus group Enteric Coated Mycophenolic Acid (MPA) During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA. Everolimus group RAD001 During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA. Everolimus group Corticosteroids During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA. Everolimus group Cyclosporin A (CsA) During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA. Control group Cyclosporin A (CsA) During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA. Everolimus group Basiliximab During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
- Primary Outcome Measures
Name Time Method Renal Function by Glomerular Filtration Rate (GFR) Via Cockcroft-Gault Method Month 6 The study was terminated prematurely and not powered for efficacy.
- Secondary Outcome Measures
Name Time Method Renal Function by GFR Via Modification of Diet in Renal Diseases (MDRD) and Nankivell Method Month 6 The study was terminated prematurely and not powered for efficacy.
Renal Function by Serum Creatinine Months 6, 12, 24, 36, 48 and 60 The study was terminated prematurely and not powered for efficacy.
Biopsy Proven Acute Rejection (BPAR), Graft Loss and Death Months 6, 12, 24, 36, 48 and 60 The study was terminated prematurely and not powered for efficacy.
Occurrence of Treatment Failures Month 6 The study was terminated prematurely and not powered for efficacy.
Evolution of Renal Function (Creatinine Slope) Week 7, Month 6 The study was terminated prematurely and not powered for efficacy.
CD25 Saturation on Lymphocytes Month 6 Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death Months 6, 12, 24, 36, 48 and 60 Participants with adverse events (serious plus non-serious), serious adverse events and death were reported.
Renal Function by GFR Over Time Months 12, 24, 36, 48 and 60 Renal Function by Proteinuria Months12, 24, 36, 48 and 60
Trial Locations
- Locations (1)
Novartis Investigative Site
🇩🇪München, Germany