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Completed

NCT Number: NCT00229138

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

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.

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Key information

Conditions

Kidney Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

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

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.

Treatment and study plan

EC-MPS, Tacrolimus

Drug

Primary outcomes

  1. renal function at 6 months posttransplant as measured by glomerular filtration rate

    Time frame: 6 months

Secondary outcomes

  1. Efficacy as measured by combined incidence of biopsy proven acute rejection episodes, graft loss, and death at 6 months

  2. Renal function as measured by calculated creatinine clearance

  3. Cockcroft-Gaultand serum creatinine at 6 months

  4. Gastrointestinal tolerability as measured by gastrointestinal

  5. symptom rating scale (GSRS) at various time points

  6. Safety as measured by incidence of adverse events

  7. Effects on glucose metabolism at months 3 and 6 after transplantation.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 29, 2005
Registry last updated
Feb 7, 2017

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.

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