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
Verified date | February 2017 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Novartis | Basel |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Switzerland,
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
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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