This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: September 27, 2005
Last updated: February 3, 2017
Last verified: February 2017
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: No masking
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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00229138

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

Additional Information:
Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00229138     History of Changes
Other Study ID Numbers: CERL080A2409
Study First Received: September 27, 2005
Last Updated: February 3, 2017

Keywords provided by Novartis:
De novo kidney recipients,
glomerular filtration rate
Treatment in de novo kidney recipients

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on June 23, 2017