Product Name: CellCept [mycophenolate mofetil]
Date of Report: 11/1/2004
Phase: II
A pilot study of the pharmacokinetics, safety and efficacy of mycophenolate mofetil (CellCept) and sirolimus (Rapamune) in renal transplantation when used in conjunction with daclizumab (Zenapax) and corticosteroids.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
A Study of the Effect of CellCept (Mycophenolate Mofetil) on Renal Function After Withdrawal of Cyclosporine in Kidney Transplant Patients
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
Kidney Spare the Nephron (STN) study A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
Multicenter, prospective, randomized, open-label trial comparing the efficacy and safety of CellCept® with delayed introduction of sirolimus and discontinuation of cyclosporine, to those of standard immunosuppression comprising Cellcept and long-term continuation of cyclosporine in renal transplant recipients receiving an induction by Zenepax® and treated with corticosteroids for 8 months
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: III
An open, prospective, randomized, controlled study comparing CellCept® (mycophenolate mofetil, MMF) administered as a component of tacrolimus based immunosuppression therapy, at a loading dose of 3 g daily during the initial post-transplant period versus CellCept® administered at a dose of 2 g daily, in recipients of renal allografts: a multicentre pilot study
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: III
OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: 5/1/2006
Phase: III
Multicentre, prospective, randomized, controlled, open-label trial evaluating the benefit on renal function of an introduction of CellCept combined with a half-dose of cyclosporine versus a group with usual doses of cyclosporine in renal transplant recipients with altered renal function.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
A Study of a Steroid Sparing Regimen in Combination With CellCept, Zenapax and Sirolimus in the Prevention of Acute Renal Allograft Rejection.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: II
A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: 10/2/2006
Phase: III
The use of daclizumab (Zenapax) and mycophenolate mofetil (CellCept) in combination with corticosteroids and Neoral (low dose versus low dose followed by complete withdrawal) to optimize renal function in recipients of renal allografts.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
A Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients Switched from EC-MPS.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: 5/1/2008
Phase: IV
An open-label, prospective, randomized, controlled, multi-center study assessing fixed dose vs. concentration controlled CellCept regimens for patients following a single organ renal transplantation in combination with full dose and reduced dose calcineurin inhibitors.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.
Product Name: Zenapax [daclizumab]
Date of Report: 1/1/2006
Phase: III
Multicenter, randomized, open trial, comparing the safety and efficacy of two administrations of Zenapax® versus Thymoglobulin®, both in combination with delayed introduction of Neoral®, CellCept® and steroids, in patients receiving their first renal transplantation
Product Name: Zenapax [daclizumab]
Date of Report: 6/4/2007
Phase: IV
Immune response to neoantigen and recall antigen in pediatric renal transplant recipients treated with the IL-2Rα monoclonal antibody, daclizumab (Zenapax).
