Extension Study of Enteric-coated Mycophenolate Sodium With Short-term or no Steroid Use Compared With Enteric-coated Mycophenolate Sodium With Standard Steroid Therapy in de Novo Kidney 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

NCT00240955

CERL080A2404E1

Details and patient eligibility

About

The objective of this study is to assess the long-term safety and tolerability of EC-MPS on the patients who completed the core study and wish to continue treatment on EC-MPS.

Enrollment: 79 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria/ Exclusion Criteria

• All patients who completed the core study and who are still receiving the EC-MPS and wish continue treatment with EC-MPS and from whom written informed consent has been obtained

Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)