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Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants

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Novartis

Status and phase

Completed
Phase 3

Conditions

Renal Transplantation

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00238940
CERL080A2405DE01E1

Details and patient eligibility

About

This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.

Enrollment

55 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion/ Exclusion criteria

  • All patients who completed study CERL080A2405-DE01 and who are willing to continue treatment with EC-MPS.

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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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