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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
This study is currently recruiting patients.
Verified by Novartis September 2005
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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
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
Resources
- NIH Pediatric Rheumatology Clinic (National Institute of Arthritis and Musculoskeletal and Skin Diseases)
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