Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182559
Status:
COMPLETED
Last Update Posted:
2014-02-05
First Post:
2005-09-10
Brief Title:
The Vienna Prograf and Endothelial Progenitor Cell Study
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
The Vienna Prograf and Endothelial Progenitor Cell Study
Status:
COMPLETED
Status Verified Date:
2014-02
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:
The aim of the study is to determine if the conversion from the immunosuppressive agent cyclosporine to tacrolimus contributes to an improvement of the cardiovascular risk factors better kidney function and immune system
Detailed Description:
In addition to hypertension diabetes hyperlipidemia and smoking as well as other non-traditional risk factors such as elevated C-reactive protein homocysteine Lpa or reduced renal function depletion of endothelial progenitor cells EPC in the peripheral circulation may represent another important explanation for the excess cardiovascular morbidity of kidney transplant recipients In this context the potential association of immunosuppressive therapy with EPCs in kidney transplant recipients deserves special consideration The use of tacrolimus associated with a more favorable cardiovascular risk factors profile in terms of improved blood pressure and lipid levels in kidney transplant recipients compared to cyclosporine users Therefore one can speculate whether tacrolimus users might have greater EPC counts compared to patients treated with cyclosporine
In a pilot study we cross-sectionally studied EPC counts in 90 stable middle-aged kidney transplant recipients From multivariate analyses we found a independent inverse association between EPC counts and body mass index and systolic blood pressure Statin use was associated with greater EPC counts while patients receiving azathioprine had lower EPC counts These findings raised the hypothesis whether EPCs are responsible at least in part for the well-established association between these factors and cardiovascular outcomes
Cystatin C is superior to serum creatinine as a marker of kidney function since cystatin C is a more sensitive marker than serum creatine for small changes in glomerular filtration rate Until now there are no available data on the change of cystatin C as a measure of graft function after conversion of a cyclosporine based immunosuppressive regimen to tacrolimus
There is accumulating evidence for an important pathogenetic role of donor-reactive antibodies in kidney allograft rejection Recent studies suggest an anti-humoral activity of tacrolimus in the setting of chronic rejection Recent findings suggest that in patients who are on cyclosporine tacrolimus rescue therapy could efficiently inhibit antibody formation
Objective 1 To evaluate the change in endothelial progenitor cell EPC count in kidney graft recipients converted from cyclosporine to tacrolimus
Objective 2 To evaluate the change in cystatin C as a measure of renal function in kidney graft recipients converted from cyclosporine to tacrolimus
Objective 3 To determine the effect of tacrolimus on humoral alloreactivity in kidney graft recipients Study design A 21 randomized parallel group open-label prospective trial comparing two different immunosuppressive regimens in approximately 148 patients Group A Convert to tacrolimus in combination withwithout mycophenolate mofetil andor steroids Group B Maintain cyclosporine in combination withwithout mycophenolate mofetil andor steroids Patients will be followed up for 24 months after conversion
In an amendment August 2006 we registered pharmacogenetic analyses of the multi-drug resistance transporter 1 MDR1 gene gene symbol ABCB1 The patients DNA is extracted from peripheral venous blood manually with industrial extraction kits Two gene sections are amplified by polymerase chain reaction PCR Mutations are determined by restriction enzymes restriction fragment length polymorphisms RFLP
In a pilot study we cross-sectionally studied EPC counts in 90 stable middle-aged kidney transplant recipients From multivariate analyses we found a independent inverse association between EPC counts and body mass index and systolic blood pressure Statin use was associated with greater EPC counts while patients receiving azathioprine had lower EPC counts These findings raised the hypothesis whether EPCs are responsible at least in part for the well-established association between these factors and cardiovascular outcomes
Cystatin C is superior to serum creatinine as a marker of kidney function since cystatin C is a more sensitive marker than serum creatine for small changes in glomerular filtration rate Until now there are no available data on the change of cystatin C as a measure of graft function after conversion of a cyclosporine based immunosuppressive regimen to tacrolimus
There is accumulating evidence for an important pathogenetic role of donor-reactive antibodies in kidney allograft rejection Recent studies suggest an anti-humoral activity of tacrolimus in the setting of chronic rejection Recent findings suggest that in patients who are on cyclosporine tacrolimus rescue therapy could efficiently inhibit antibody formation
Objective 1 To evaluate the change in endothelial progenitor cell EPC count in kidney graft recipients converted from cyclosporine to tacrolimus
Objective 2 To evaluate the change in cystatin C as a measure of renal function in kidney graft recipients converted from cyclosporine to tacrolimus
Objective 3 To determine the effect of tacrolimus on humoral alloreactivity in kidney graft recipients Study design A 21 randomized parallel group open-label prospective trial comparing two different immunosuppressive regimens in approximately 148 patients Group A Convert to tacrolimus in combination withwithout mycophenolate mofetil andor steroids Group B Maintain cyclosporine in combination withwithout mycophenolate mofetil andor steroids Patients will be followed up for 24 months after conversion
In an amendment August 2006 we registered pharmacogenetic analyses of the multi-drug resistance transporter 1 MDR1 gene gene symbol ABCB1 The patients DNA is extracted from peripheral venous blood manually with industrial extraction kits Two gene sections are amplified by polymerase chain reaction PCR Mutations are determined by restriction enzymes restriction fragment length polymorphisms RFLP
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3932004 | OTHER | Ethics Committee Medical University of Vienna | None |