Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants

Novartis55 enrolled

Overview

This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Renal Transplantation

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion/ Exclusion criteria \- All patients who completed study CERL080A2405-DE01 and who are willing to continue treatment with EC-MPS. Other protocol-defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation.

Secondary Outcomes

Efficacy based on the level of serum creatinine and calculated creatinine clearance 12 months post transplantation.

Safety and tolerability of enteric-coated mycophenolate sodium at 6 and 12 months post transplantation

Pharmacokinetics enteric coated mycophenolate sodium in a randomized subgroup

Efficacy based on the incidence of biopsy-proven acute rejection, graft loss or death 6 and 12 months post transplantation.

Efficacy based on the incidence of biopsy-proven acute rejection at 6 and 12 months post transplantation.

Data from ClinicalTrials.gov

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