Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231764
Status:
COMPLETED
Last Update Posted:
2008-04-24
First Post:
2005-09-30
Brief Title:
MMF Daclizumab and Corticosteroids as Mainstay Immunosuppression in Renal Transplant Patients
Sponsor:
Ekberg Henrik MD
Organization:
Ekberg Henrik MD
Study Overview
Official Title:
Evaluating Safety and Efficacy of MMF Daclizumab and Corticosteroids as Mainstay Immunosuppression in Combination With Low-Dose CsA Tac or Sir in Comparison to Current Standard Immunosuppression MMF CsA and Corticosteroids in Renal Tx
Status:
COMPLETED
Status Verified Date:
2008-04
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 determine the renal function as expressed by the glomerular filtration rate at 12 months in renal transplant recipients receiving mycophenolate mofetil daclizumab and corticosteroids as mainstay immunosuppression in combination with low-dose cyclosporine tacrolimus or sirolimus and compare it to that of renal transplant recipients receiving standard immunosuppression with mycophenolate mofetil normal dose cyclosporine and corticosteroids
Detailed Description:
The purpose of the SYMPHONY study is to compare four different immunosuppressive regimens They are each given for one year The following four combinations are tested in four groups of patients
Group A Cyclosporine in a normal dosage mycophenolate mofetil MMF and corticosteroids
Group B Daclizumab in the first two months after transplantation cyclosporine in a lower dosage compared to group A mycophenolate mofetil MMF and corticosteroids
Group C Daclizumab in the first two months after transplantation tacrolimus in low dosage mycophenolate mofetil MMF and corticosteroids
Group D Daclizumab in the first two months after transplantation sirolimus in a low dosage mycophenolate mofetil MMF and corticosteroids
All drugs of the four immunosuppressive regimes are approved by the Health Authorities in the participating country for use in kidney transplantation The regimen administered to the patients in Group A represents a standard treatment currently given with success to many transplant patients in a number of countries in the world The treatments in Groups B C and D are experimental in the sense that either the doses administered are lower than the ones used before andor the combination of drugs is experimental Nevertheless there are results of scientific studies indicating that they are all effective alternatives and that they might have advantages compared to the standard immunosuppressive regimen in particular as far as their safety side effects long-term toxicity is concerned However from the previous clinical experience it is not yet clear which regimen offers the most advantages for the patients To find this out in SYMPHONY the four regimens are administered to the four groups of patients A-D and the results in the different groups will be compared
Group A Cyclosporine in a normal dosage mycophenolate mofetil MMF and corticosteroids
Group B Daclizumab in the first two months after transplantation cyclosporine in a lower dosage compared to group A mycophenolate mofetil MMF and corticosteroids
Group C Daclizumab in the first two months after transplantation tacrolimus in low dosage mycophenolate mofetil MMF and corticosteroids
Group D Daclizumab in the first two months after transplantation sirolimus in a low dosage mycophenolate mofetil MMF and corticosteroids
All drugs of the four immunosuppressive regimes are approved by the Health Authorities in the participating country for use in kidney transplantation The regimen administered to the patients in Group A represents a standard treatment currently given with success to many transplant patients in a number of countries in the world The treatments in Groups B C and D are experimental in the sense that either the doses administered are lower than the ones used before andor the combination of drugs is experimental Nevertheless there are results of scientific studies indicating that they are all effective alternatives and that they might have advantages compared to the standard immunosuppressive regimen in particular as far as their safety side effects long-term toxicity is concerned However from the previous clinical experience it is not yet clear which regimen offers the most advantages for the patients To find this out in SYMPHONY the four regimens are administered to the four groups of patients A-D and the results in the different groups will be compared
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