Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients

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Novartis

Status and phase

Completed
Phase 4

Conditions

Kidney Transplantation

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00154206
CERL080AFR03

Details and patient eligibility

About

The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated.

Sex

All

Ages

5 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Recipients of a primary renal transplantation
  • Recipients of a renal transplantation only

Exclusion criteria

  • Recipients of a multi-organ transplantation
  • Unable to take an oral medication
  • Requiring an induction therapy with polyclonal, monoclonal antibodies (OKT3, ATG, ALG).

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

1

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Data sourced from clinicaltrials.gov

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