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

Completed · Phase 4

Conditions studied: Kidney Transplantation

In brief

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.

Key facts

Study ID

NCT00229138

Run by

Novartis Pharmaceuticals

People needed

291

Starts

2005-09-01

Expected to finish

2007-03-01

Last updated by the study team

2017-02-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Novartis — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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