Phase 3
Completed N=222
Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients
Renal Transplantation
Source: ClinicalTrials.gov NCT00413920 ↗
Enrolled (actual)
222
Serious AEs
63.5%
Results posted
Feb 2011
Primary outcomePrimary: Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation — 20; 16 Number of participants
Summary
This study will investigate the efficacy and safety of a steroid avoidance regimen in comparison with steroid treatment in combination with an initially higher dose of enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal transplant recipients. Patients will be randomly allocated to receive either EC-MPS or steroids in combination with EC-MPS. Patients of both treatment groups will receive monoclonal antibody induction therapy and a perioperative bolus of steroids and cyclosporine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation |
20; 16 | — |
| SECONDARY The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months |
13; 8; 5; 3; 2; 5 | — |
| SECONDARY Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months |
17; 8; 10; 5; 5; 1 | — |
| SECONDARY Number of Participants With Subclinical Histological Rejections |
7; 6; 12; 17; 2; 5 | — |
| SECONDARY Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status |
8; 4; 6; 1; 3; 3 | — |
| SECONDARY Number of Participants Requiring Steroids in Non-steroid Treatment Group |
25; 20 | — |
Eligibility Criteria
Inclusion Criteria
- Primary donor kidney transplant
- Panel reactive antibody (PRA) ≤ 20%
Exclusion Criteria
- Multi-organ transplantation including dual kidneys or previous transplant with any other organ different from kidney
- Non-heart beating donor or kidney from a non-compatible donor
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00413920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.