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NCT00154206 Clinical Trial

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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00154206
Other study ID # CERL080AFR03
Secondary ID
Status Completed
Phase Phase 4
First received September 8, 2005
Last updated February 22, 2017
Start date September 2004

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date
Est. primary completion date January 2007
Accepts healthy volunteers
Gender All
Age group 5 Years to 16 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Switzerland Novartis Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Within the 6 and 12 months post transplantation
Secondary Incidence of acute rejection resistant to steroids
Secondary Incidence of graft loss and death
Secondary Renal function by creatinine and creatinine clearance (Schwartz formula)
Secondary Incidence of premature study drug discontinuation due to safety reason
Secondary Pharmacokinetic profile of Myfortic.
Secondary Frequency of adverse events, incidence of clinically notable laboratory abnormalities, and change on vital signs.
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