Skip to main content
OpenTrials
Completed

NCT Number: NCT00419926

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Transplantation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis

Basel, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Prednisone

Drug

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

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

    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

  1. Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death

    Time frame: 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.)

  2. Renal Function Assessed by Glomerular Filtration Rate (GFR)at Each Visit

    Time frame: 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.

  3. Renal Function Assessed by Serum Creatinine at Each Visits

    Time frame: at 21 days, 84 days and 180 days

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 9, 2007
Registry last updated
Mar 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.