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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00154206

First received: September 8, 2005

Last updated: November 1, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

November 1, 2011

Start Date ^ICMJE

September 2004

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00154206 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Kidney Transplantation

Intervention ^ICMJE

Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

5 Years to 16 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00154206

Other Study ID Numbers ^ICMJE

CERL080AFR03

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis

Information Provided By

Novartis

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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