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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00229138
First Posted: September 29, 2005
Last Update Posted: February 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 biopsy proven 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00229138     History of Changes
Other Study ID Numbers: CERL080A2409
First Submitted: September 27, 2005
First Posted: September 29, 2005
Last Update Posted: February 7, 2017
Last Verified: February 2017

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:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action