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

Novartis

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: EC-MPS, Tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00229138

CERL080A2409

Details and patient eligibility

About

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.

Enrollment: 291 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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291 participants in 2 patient groups

reduced Tacrolimus

Experimental group

Treatment:

Drug: EC-MPS, Tacrolimus

Reference Tacrolimus

Active Comparator group

Treatment:

Drug: EC-MPS, Tacrolimus