A Randomized, Multicenter, Parallel-group, Open-label Study to Evaluate the Therapeutic Benefit of an Initially Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Dosing Regimen, in Combination With Cyclosporine and Corticosteroids in de Novo Renal Transplant Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 313
- Locations
- 1
- Primary Endpoint
- Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Intensified Mycophenolate Sodium (Myfortic) dosing regimen
In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
Intervention: Enteric-coated mycophenolate sodium (Myfortic) (Drug)
Intensified Mycophenolate Sodium (Myfortic) dosing regimen
In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
Intervention: Cyclosporine (Neoral) (Drug)
Intensified Mycophenolate Sodium (Myfortic) dosing regimen
In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
Intervention: Prednisone (Drug)
Standard Mycophenolate Sodium (Myfortic) dosing regimen
In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440 mg/day had to be maintained throughout the whole study.
Intervention: Enteric-coated mycophenolate sodium (Myfortic) (Drug)
Standard Mycophenolate Sodium (Myfortic) dosing regimen
In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440 mg/day had to be maintained throughout the whole study.
Intervention: Cyclosporine (Neoral) (Drug)
Standard Mycophenolate Sodium (Myfortic) dosing regimen
In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440 mg/day had to be maintained throughout the whole study.
Intervention: Prednisone (Drug)
Outcomes
Primary Outcomes
Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death
Time Frame: 6 months
To evaluate therapeutic benefit by comparing the efficacy defined as the number of participants with treatment failure (biopsy-proven acute rejection \[BPAR\], graft loss \[GFL\] or death) at 6 months post-transplant. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)
Secondary Outcomes
- Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death(21 and 84 days)
- Renal Function Assessed by Glomerular Filtration Rate (GFR)at Each Visit(at 21 days, 84 days and 180 days)
- Renal Function Assessed by Serum Creatinine at Each Visits(at 21 days, 84 days and 180 days)