Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal Function (Nankivell Formula) at Month 12 Post Transplantation. |
71.84; 61.24 | — |
| SECONDARY Number of Participants With Occurrence of Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death |
15; 5; 139; 141; 0; 0 | — |
| SECONDARY Number of Participants With Occurrence of Treatment Failures |
29; 23; 125; 123 | — |
| SECONDARY Changes in Cardiovascular Risk From Month 4.5 to Final Assessment at Month 12 |
0.5; 0.1; 0.0; 0.8; 0.4; 0.4 | — |
| SECONDARY Number of Participants Who Experienced an Adverse Event or Serious Adverse Event |
155; 145; 95; 86 | — |
Eligibility Criteria
Inclusion Criteria
The following inclusion criteria had to be present at BL 1 (Screening visit prior to transplantation):
- Males or females, aged 18 - 65 years
- Recipients of de novo cadaveric, living unrelated or living related kidney transplants
- Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at BL 1, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility
- Patients who are willing and able to participate in the study and from whom written informed consent has been obtained
Of all patients included into the study at BL 1 (prior to transplantation), those who continued into the randomized study period had to meet the following condition at BL 2, prior to randomization:
- Patients had to be on an immunosuppressive regimen with EC-MPS (target dose; 1440 mg/day, if tolerated; minimal dose: 720 mg/day), cyclosporine and corticosteroids
- Patients with an actual serum creatinine = 25%
- Patients with already existing antibodies against the HLA-type of the receiving transplant
- Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
Of all patients included into the study at BL 1 (prior to transplantation), those who met one or more of the following criteria at BL 2, prior to randomization, should not continue into the randomized study period:
- Graft loss or death
- Changes to the immunosuppressive regimen prior to randomization due to immunologic reasons
- Patients who suffered from severe rejection (>= BANFF II acute rejection), recurrent acute rejection, or steroid resistant acute rejection
- Proteinuria > 1g/day
Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00154310). 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.