Status:

COMPLETED

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

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Kidney Transplantation

Eligibility:

All Genders

5-16 years

Phase:

PHASE4

Brief Summary

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 vari...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2004

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT00154206

Start Date

September 1 2004

Last Update

February 24 2017

Active Locations (1)

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1

Novartis

Basel, Switzerland