Phase 3
Completed N=128
Intensified vs. Standard Dose Therapy With Mycophenolate Sodium Plus Cyclosporin Microemulsion and Corticosteroid Combination in Patients With de Novo Renal Transplant Patients
Renal Transplantation
Source: ClinicalTrials.gov NCT00369278 ↗
Enrolled (actual)
128
Serious AEs
65.6%
Results posted
Jan 2011
Primary outcomePrimary: Time to First Occurrence of a Mycophenolic Acid (MPA) Plasma Concentration of ≥ 40 mg*h/L — 7.00; 43.00 Days
Summary
This study will assess the association of an initially intensified dosing regimen of enteric-coated mycophenolate sodium (EC-MPS) during the first 6 weeks post renal transplantation with acute rejections relative to the rapid achievement of an MPA (mycophenolic acid) exposure of ≥ 40 mg*h/L compared to a standard dosing regimen of EC-MPS. Additionally, this study will assess safety and tolerability of the intensified dosing regimen of EC-MPS. This study will be conducted in 2 stages (Stage I and Stage II).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Occurrence of a Mycophenolic Acid (MPA) Plasma Concentration of ≥ 40 mg*h/L |
7.00; 43.00 | — |
| PRIMARY Time to First Occurrence of Any Treatment Failure During the First 6 Months Post-treatment or at Month 6 Post-treatment |
— | — |
| PRIMARY Number of Participants With Any Treatment Failure |
19; 24 | — |
| SECONDARY Number of Participants With Single Treatment Failures |
2; 11; 1; 2; 0; 0 | — |
| SECONDARY Rates of Events for Treated Acute Rejection, Death, Graft Loss, or Loss to Follow up on Day 28, Day 84, and Day 180 |
— | — |
| SECONDARY Time to "Event" for the Composite Endpoint as Well as All Individual Components of That Endpoint "Treatment Failure" Including Clinical Rejections |
— | — |
| SECONDARY Renal Function as Measured by Serum Creatinine |
8.0; 7.8; 2.2; 2.6 | — |
| SECONDARY Renal Function as Measured by Glomerular Filtration Rate (GFR) |
9.0; 9.4; 41.1; 40.6; 12.1; 12.0 | — |
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 baseline, 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
- Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
- Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
- Patients receiving a kidney from a non-heart beating donor
- Patients who are recipients of A-B-O incompatible transplants
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00369278). 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.