Phase 4
Completed N=313
Evaluation of the Therapeutic Benefit of an Initial Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Regimen in Renal Transplant Patients
Source: ClinicalTrials.gov NCT00419926 ↗Enrolled (actual)
313
Serious AEs
46.7%
Results posted
Jan 2011
Primary outcomePrimary: Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death — 33; 36 number of participants
Summary
The purpose of this study is to determine if an initial intensified enteric-coated mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post renal transplantation provides improved efficacy, with a similar safety profile, compared to a standard regimen of Myfortic.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death |
26; 35 | — |
| SECONDARY Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death |
14; 20; 26; 33 | — |
| SECONDARY Renal Function Assessed by Glomerular Filtration Rate (GFR)at Each Visit |
47.3; 46.8; 52.1; 51.8; 53.5; 51.3 | — |
| SECONDARY Renal Function Assessed by Serum Creatinine at Each Visits |
— | — |
Eligibility Criteria
Inclusion Criteria
- Males or females, 18 to 65 years old
- First or second time kidney transplant patients
- For females capable of becoming pregnant, negative pregnancy test prior to entry into trial and effective birth control during trial and 3 months after stopping trial medication
Exclusion Criteria
- Previous graft loss due to immunological reasons in the 1st year after the 1st transplant
- Multi-organ recipients or previous transplant of another organ, different from the kidney
- Recipients from a non-heart-beating donor
- Known hypersensitivity to mycophenolic acid or cyclosporine
- HIV positive or Hepatitis B surface antigen positive
- History of malignancy (past 5 years)
- Pregnancy or planned pregnancy, lactating, or unwillingness to use effective contraception.
- Evidence of severe liver disease
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00419926). 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.