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Completed

NCT Number: NCT00154206

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

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.

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Key information

Conditions

Kidney Transplantation

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis

Basel, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enteric-Coated Mycophenolate Sodium (EC-MPS)

Drug

Primary outcomes

  1. 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

  1. Within the 6 and 12 months post transplantation

  2. Incidence of acute rejection resistant to steroids

  3. Incidence of graft loss and death

  4. Renal function by creatinine and creatinine clearance (Schwartz formula)

  5. Incidence of premature study drug discontinuation due to safety reason

  6. Pharmacokinetic profile of Myfortic.

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
First posted
Sep 12, 2005
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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