Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients

Novartis

Status and phase: Completed; Phase 4

Conditions: Renal Transplantation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00241059

CERL080A2405LA01E1

Details and patient eligibility

About

The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to assess the long-term safety of EC-MPS.

Enrollment: 183 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who completed study CERL080A2405-LA01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

Exclusion criteria

• 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)

---

183 participants in 1 patient group

EC-MPS arm

Experimental group

Treatment:

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