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

NCT00419926 | Completed Phase 4 Results

• 1 other identifier: CERL080A2419
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation

Keywords

Renal, Kidney, Intensified, Enteric-coated mycophenolate sodium, Transplant

Outcome Measures

Primary Outcomes (1)

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

  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.)

  6 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Intensified Mycophenolate Sodium (Myfortic) dosing regimen

EXPERIMENTAL

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.

Drug: Enteric-coated mycophenolate sodium (Myfortic); Drug: Cyclosporine (Neoral); Drug: Prednisone

Standard Mycophenolate Sodium (Myfortic) dosing regimen

ACTIVE COMPARATOR

In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440 mg/day had to be maintained throughout the whole study.

Drug: Enteric-coated mycophenolate sodium (Myfortic); Drug: Cyclosporine (Neoral); Drug: Prednisone

Interventions

Enteric-coated mycophenolate sodium (Myfortic) DRUG

1440 mg/day for the standard dose. 2880 mg/day for the initial intensified dosage, 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; Standard Mycophenolate Sodium (Myfortic) dosing regimen

Cyclosporine (Neoral) DRUG

cyclosporine microemulsion in galenic form capsules starting at twice a day for a dose of 8-10 mg/kg/day adjusted if necessary to achieve protocol specific target levels

Intensified Mycophenolate Sodium (Myfortic) dosing regimen; Standard Mycophenolate Sodium (Myfortic) dosing regimen

Prednisone DRUG

20 mg orally per day reduced according to center practice for a minimum dose of 5 mg/day.

Intensified Mycophenolate Sodium (Myfortic) dosing regimen; Standard Mycophenolate Sodium (Myfortic) dosing regimen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis

Basel, Switzerland

Location

MeSH Terms

Interventions

Mycophenolic Acid; Cyclosporine; Prednisone

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 8, 2007
• First Posted: January 9, 2007
• Study Start: December 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 1, 2011
• Results First Posted: January 11, 2011

Record last verified: 2011-02

Locations

CH (1)