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

A Multicenter, Open, Single Arm, Pilot Study to Evaluate Efficacy, Tolerability and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00154206

Enrollment

Registered

2005-09-12

Start date

2004-09-30

Completion date

Unknown

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Enteric-coated mycophenolate sodium,, de novo,, renal transplantation,, pediatric, De novo pediatric renal transplantation

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 variations are also evaluated.

Interventions

DRUGEnteric-Coated Mycophenolate Sodium (EC-MPS)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 16 Years

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 /

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Incidence of acute rejection resistant to steroids	—
Incidence of graft loss and death	—
Renal function by creatinine and creatinine clearance (Schwartz formula)	—
Within the 6 and 12 months post transplantation	—
Pharmacokinetic profile of Myfortic.	—
Frequency of adverse events, incidence of clinically notable laboratory abnormalities, and change on vital signs.	—
Incidence of premature study drug discontinuation due to safety reason	—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026