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

Novartis

Status and phase: Completed; Phase 3

Conditions: Renal Transplantation

Treatments: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00238940

CERL080A2405DE01E1

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)