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Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.

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Novartis

Status and phase

Completed
Phase 3

Conditions

Kidney de Novo Transplant

Treatments

Drug: Enteric-coated Mycophenolate sodium (EC-MPS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00238992
CERL080A2405ES01

Details and patient eligibility

About

All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.

The purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo kidney allograft recipients.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • Male or female patients undergoing first kidney transplant.
  • Patients aged 18 -70 years.
  • Patients receiving an ABO identical or compatible graft. Exclusion Criteria
  • Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.
  • Positive HBsAg test
  • Pre-Transplant PRA >50% or historical PRA >75% Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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