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

Keywords

• Enteric-coated mycophenolate sodium,
• de novo,
• renal transplantation,
• pediatric
• De novo pediatric renal transplantation

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Interventions

• DrugEnteric-Coated Mycophenolate Sodium (EC-MPS)

Primary outcomes

1. 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 outcomes

1. Within the 6 and 12 months post transplantation

2. Incidence of acute rejection resistant to steroids

3. Incidence of graft loss and death

4. Renal function by creatinine and creatinine clearance (Schwartz formula)

5. Incidence of premature study drug discontinuation due to safety reason

6. Pharmacokinetic profile of Myfortic.

7. Frequency of adverse events, incidence of clinically notable laboratory abnormalities, and change on vital signs.

Publications

• 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. PubMed 18985393 ↗