Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A0107

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Novartis

Status and phase

Completed
Phase 3

Conditions

Renal Transplant

Treatments

Drug: Mycophenolate sodium (enteric coated)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00149916
CERL080A107E

Details and patient eligibility

About

Aim of study is to provide safety and tolerability data on enteric-coated mycophenolate sodium in regard to adverse events, serious adverse events and patient and graft survival. After successful completion of the study CERL080A0107 study, patients could continue to receive enteric-coated mycophenolate sodium.

Enrollment

139 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Cadaveric or living donor kidney transplant recipients who completed the study CERL080A0107

Exclusion criteria

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

139 participants in 1 patient group

Mycophenolate sodium (enteric coated)
Experimental group
Treatment:
Drug: Mycophenolate sodium (enteric coated)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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