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

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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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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