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Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00229138
First received: September 27, 2005
Last updated: January 28, 2011
Last verified: January 2011
History of Changes
  Purpose

This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.


Condition Intervention Phase
Kidney Transplantation
 Drug: EC-MPS, Tacrolimus
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Six-month, Prospective, Multicenter, Open Label, Parallel, Randomized Study of the Safety, Tolerability and Efficacy of EC-MPS With Basiliximab, Corticosteroids and Two Different Levels of Tacrolimus in de Novo Renal Transplant Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • renal function at 6 months posttransplant as measured by glomerular filtration rate [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Efficacy as measured by combined incidence of biopsyproven acute rejection episodes, graft loss, and death at 6 months
  • Renal function as measured by calculated creatinine clearance
  • Cockcroft-Gaultand serum creatinine at 6 months
  • Gastrointestinal tolerability as measured by gastrointestinal
  • symptom rating scale (GSRS) at various time points
  • Safety as measured by incidence of adverse events
  • Effects on glucose metabolism at months 3 and 6 after transplantation.

Enrollment: 291
Study Start Date: September 2005
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: reduced Tacrolimus Drug: EC-MPS, Tacrolimus
Active Comparator: Reference Tacrolimus Drug: EC-MPS, Tacrolimus

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Male or female kidney transplantation patients, 18 to 70 years of age, receiving a primary cadaveric, living unrelated, or non-HLA identical living related donor kidney.
  • The renal cold ischemic time (CIT) must be <30 hours
  • The age of the donor must be between 10 and 65 years

Exclusion Criteria

  • Patients who have previously received an organ transplant
  • Patients who are recipients of a multiple organ transplants
  • Recipients of non heart-beating donor organs
  • ABO incompatibility against the donor

Other protocol-defined exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00229138

Locations
United States, New Jersey
Novartis
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00229138     History of Changes
Other Study ID Numbers: CERL080A2409
Study First Received: September 27, 2005
Last Updated: January 28, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
United States: Food and Drug Administration

Keywords provided by Novartis:
De novo kidney recipients,
EC-MPS,
tacrolimus,
efficacy,
 safety,
glomerular filtration rate
Treatment in de novo kidney recipients

Additional relevant MeSH terms:
Mycophenolate mofetil
Tacrolimus
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013