Nafcillin Sodium Injection

Nallpen; Unipen Injection

Clinical Trial: Efficacy, Tolerability and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) with Cyclosporine Microemulsion and Steroids in Pediatric De Novo Renal Transplant Patients

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Purpose
Eligibility
Location and Contact Information
More Information

This study is currently recruiting patients.
Verified by Novartis September 2005

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00154206

Purpose

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.

Condition	Intervention	Phase
De novo pediatric renal transplantation	Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)	Phase III

MedlinePlus consumer health information

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official 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

Further Study Details:

Study start: September 2004

Eligibility

Ages Eligible for Study: 5 Years - 16 Years, Genders Eligible for Study: Both

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00154206

Novartis 41 61 324 1111

Switzerland
Novartis, Basel, Switzerland; Recruiting

Novartis 41 61 324 1111

Study chairs or principal investigators

Novartis, Study Director, Novartis

More Information

Study ID Numbers: CERL080AFR03
Last Updated: September 9, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00154206
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13

Source: ClinicalTrials.gov
Cache Date: September 14, 2005

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Efficacy, Tolerability and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) with Cyclosporine Microemulsion and Steroids in Pediatric De Novo Renal Transplant Patients - Article

General Topics A-Z

Nafcillin Sodium Injection

Nallpen; Unipen Injection

Clinical Trial: Efficacy, Tolerability and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) with Cyclosporine Microemulsion and Steroids in Pediatric De Novo Renal Transplant Patients

Jump to Section

Purpose

Eligibility

Location and Contact Information

More Information

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Efficacy, Tolerability and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) with Cyclosporine Microemulsion and Steroids in Pediatric De Novo Renal Transplant Patients - Article

General Topics A-Z

Nafcillin Sodium Injection

Nallpen; Unipen Injection

Clinical Trial: Efficacy, Tolerability and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) with Cyclosporine Microemulsion and Steroids in Pediatric De Novo Renal Transplant Patients

Jump to Section

Purpose

Eligibility

Location and Contact Information

More Information

Take control over your directory listings...INSTANTLY

Limited Time Offer!!!

Popular Treatments

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