Phase 4
N=36
Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients
Chronic Renal Failure
Bottom Line
View on ClinicalTrials.gov: NCT00965094 ↗Enrolled (actual)
36
Serious AEs
38.9%
Results posted
Aug 2014
Primary outcome: Primary: Renal Function Assessed as Glomerula Filtration Rate (GFR) - Nankivell Method - 9 Months After Renal Transplantation (LOCF) — 15.0; 16.6 mL/min/1.73m^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Everolimus (Drug); Tacrolimus (FK506) (Drug); Basiliximab (Drug); Enteric Coated Mycophenolate Sodium (EC-MPS) (Drug); Corticosteroids (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal Function Assessed as Glomerula Filtration Rate (GFR) - Nankivell Method - 9 Months After Renal Transplantation (LOCF) |
15.0; 16.6 | — |
| SECONDARY Assessment of GFR by the Cockcroft-Gault Method (LOCF) |
72.6; 72.7 | — |
| SECONDARY Participants Who Had Occurrence of Biopsy Proven Acute Rejection, Graft Loss or Death. |
14; 14; 1; 1 | — |
| SECONDARY Participants Who Had Occurrence of Treatment Failure. |
10; 14; 5; 1 | — |
| SECONDARY Change in Renal Function (Creatinine Slope) |
0.7; 0.7; 0.7; 0.8; 0.8; 0.9 | — |
Summary
The primary objective of this trial is to show non-inferiority of a CNI-free regimen with respect to the renal function at Month 9 post Tx assessed by glomerular filtration rate - Nankivell method - as compared to the standard CNI-based regimen in de novo renal transplant patients.
Eligibility Criteria
Inclusion criteria
- 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 screening, 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.
Exclusion criteria
- More than one previous renal transplantation
- Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
- Donor age: 65 years
- Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
- Patients who had received an investigational drug within 4 weeks of the baseline period
- Patients who are recipients of A-B-O incompatible transplants or T cell cross-match positive transplants
- Patients with already existing antibodies against the HLA-type of the receiving transplant
- Patients with any known hypersensitivity to Simulect®, Certican®, mycophenolic acid, Prograf®, other drugs similar to Certican® (e.g., macrolides), or other components of the formulations.
- Patients who have received an investigational immunosuppressive drug within four weeks prior to study entry (Baseline visit 1)
- Patients with thrombocytopenia (platelets 3 times UNL)
- Females of childbearing potential who are planning to become pregnant, who are pregnant or lactating, and/or who are unwilling to use effective means of contraception (see also section 8.2)
- Presence of a clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that in the opinion of the investigator would interfere with the appropriate conduct of the study
- Evidence of drug or alcohol abuse
- Patients receiving drugs known to interact with Tacrolimus and/or everolimus according to the list provided in Appendix 3 to this protocol.
- Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00965094). 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.