Evaluation of the Therapeutic Benefit of an Initial Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Regimen in Renal Transplant Patients

Phase 4

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: Enteric-coated mycophenolate sodium (Myfortic); Drug: Cyclosporine (Neoral); Drug: Prednisone

• Registration Number: NCT00419926
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-01-08
• Study First Submitted QC: 2007-01-08
• Study First Posted: 2007-01-09
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2010-12-14
• Results First Submitted QC: 2010-12-14
• Results First Posted: 2011-01-11
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-25
• Last Update Posted: 2011-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensified Mycophenolate Sodium (Myfortic) dosing regimen	Cyclosporine (Neoral)	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.
Intensified Mycophenolate Sodium (Myfortic) dosing regimen	Enteric-coated mycophenolate sodium (Myfortic)	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.
Intensified Mycophenolate Sodium (Myfortic) dosing regimen	Prednisone	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.
Standard Mycophenolate Sodium (Myfortic) dosing regimen	Enteric-coated mycophenolate sodium (Myfortic)	In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440 mg/day had to be maintained throughout the whole study.
Standard Mycophenolate Sodium (Myfortic) dosing regimen	Cyclosporine (Neoral)	In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440 mg/day had to be maintained throughout the whole study.
Standard Mycophenolate Sodium (Myfortic) dosing regimen	Prednisone	In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440 mg/day had to be maintained throughout the whole study.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death	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 Outcome Measures

Name	Time	Method
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	The overall treatment differences of the number of participants with at least one occurrence of the composite event BPAR, GFL or death at study days 21 and 84 post-transplantation. 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.)
Renal Function Assessed by Glomerular Filtration Rate (GFR)at Each Visit	at 21 days, 84 days and 180 days	The Modification of Diet in Renal Disease (MDRD) formula was used to calculate the GFR. Serum creatinine levels, age, sex and race were used to estimate the GFR levels in mL/min/1.73m\^2.
Renal Function Assessed by Serum Creatinine at Each Visits	at 21 days, 84 days and 180 days

Trial Locations

Locations (1)

Novartis; 🇨🇭 Basel, Switzerland