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

Novartis Pharmaceuticals291 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

291

Conditions

Kidney Transplantation

Interventions

EC-MPS, TacrolimusDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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