Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00138970
Status:
COMPLETED
Last Update Posted:
2005-12-01
First Post:
2005-08-29
Brief Title:
Calcineurin Inhibitor-Free Immunosuppression in Renal Transplant Recipients at Low Immunogenic Risk
Sponsor:
University of Oslo School of Pharmacy
Organization:
University of Oslo School of Pharmacy
Study Overview
Official Title:
Randomised Double-Arm Controlled Open-Label Study Comparing Calcineurin Inhibitor-Free Immunosuppression Zenapax CellCept and Prednisolone and Cyclosporine A Based Immunosuppression Sandimmun Neoral CellCept and Prednisolone on the Outcome of Renal Function and Acute Rejection in 0 DR Mis-Matched Renal Allograft Recipients
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare renal function 51Cr-EDTA clearance 12 months posttransplant in primary renal allograft recipients from cadaveric donor at low immunogenic risk 0 DR mis-match receiving immunosuppressive therapy with A Zenapax 5 doses CellCept 15 g bid aiming for TDM for total trough concentrations of 2-6 mgL and prednisolone or B Sandimmun Neoral full dose CellCept 10 g bid and prednisolone
Detailed Description:
Primary Objective To compare renal function 51Cr-EDTA clearance 12 months posttransplant in primary renal allograft recipients from cadaveric donor at low immunogenic risk 0 DR mis-match receiving immunosuppressive therapy with A Zenapax 5 doses CellCept 15 g bid aiming for TDM for total trough concentrations of 2-6 mgL and prednisolone or B Sandimmun Neoral full dose CellCept 10 g bid and prednisolone
Secondary Objectives To compare the two treatment groups with regard to patient and graft survival 12 months biopsy-proven and presumptive rejection episodes 3 and 12 months posttransplant 12 months incidence and severity of hypertension hyperlipidemia glucose intolerance incidence of infection and tolerability and success rate of TDM guided CellCept dosing in a calcineurin inhibitor-free immunosuppressive protocol over 12 months
Secondary Objectives To compare the two treatment groups with regard to patient and graft survival 12 months biopsy-proven and presumptive rejection episodes 3 and 12 months posttransplant 12 months incidence and severity of hypertension hyperlipidemia glucose intolerance incidence of infection and tolerability and success rate of TDM guided CellCept dosing in a calcineurin inhibitor-free immunosuppressive protocol over 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None