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

NCT ID: NCT00154206

Last Updated: 2017-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Brief Summary

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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

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Enteric-Coated Mycophenolate Sodium (EC-MPS)

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

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Novartis

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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Niaudet P, Charbit M, Loirat C, Lapeyraque AL, Tsimaratos M, Cailliez M, Foulard M, Dehennault M, Marquet P, Chaouche-Teyara K, Lemay D. Enteric-coated mycophenolate sodium in de novo pediatric renal transplant patients. Pediatr Nephrol. 2009 Feb;24(2):395-402. doi: 10.1007/s00467-008-1031-7. Epub 2008 Nov 5.

Reference Type BACKGROUND
PMID: 18985393 (View on PubMed)

Other Identifiers

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CERL080AFR03

Identifier Type: -

Identifier Source: org_study_id

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