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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 variations are also evaluated.

• Phase: Phase 4

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Cyclosporine; Cyclosporins; Mycophenolate mofetil; Mycophenolic Acid

Criteria

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