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

Novartis Pharmaceuticals15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Kidney Transplantation

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS)DRUG

Eligibility

Sex: ALLMin age: 5 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis

Basel, Switzerland

Outcomes

Primary Outcomes

Incidence of biopsy-proven-acute-rejection and treatment failure (defined by graft loss and/or biopsy-proven-acute-rejection and/or death and/or lost to follow-up and/or study discontinuation) within the 6 and 12 months post transplantation

Secondary Outcomes

Within the 6 and 12 months post transplantation

Incidence of acute rejection resistant to steroids

Incidence of graft loss and death

Renal function by creatinine and creatinine clearance (Schwartz formula)

Incidence of premature study drug discontinuation due to safety reason

Pharmacokinetic profile of Myfortic.

Frequency of adverse events, incidence of clinically notable laboratory abnormalities, and change on vital signs.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.