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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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