Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients

Novartis144 enrolled

Overview

The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405FR01) to continue on the same treatment and to assess the long-term safety of EC-MPS

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

144

Conditions

De Novo Kidney 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-FR01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium. Other protocol-defined inclusion / exclusion criteria may apply

Outcomes

Primary Outcomes

To assess glomerular filtration rate at month 3 post transplantation

Secondary Outcomes

Renal function of patients requiring post transplantation dialysis, experiencing slow graft function (defined as S. Creat level>264 μmol/l at D5) or with immediate graft function.

Incidence of patients requiring post transplantation dialysis, experience slow graft function (defined as S. Creat level>264 μmol/l at D5 or with immediate graft function.

Incidence of biopsy proven acute rejection, any treated acute rejection, and any treated acute rejection requiring antibody therapy, recurrent acute rejection and the severity of acute rejection episodes within 6 and 12 months

Incidence of graft and patient survival within 6 and 12 months

Safety and tolerability based on adverse event (AE) reporting.

Data from ClinicalTrials.gov

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