Ignite Creation Date:
2024-05-05 @ 10:02 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01014234
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2009-11-13
Brief Title:
Rapamycin and Regulatory T Cells in Kidney Transplantation
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
Official Title:
Rapamycin and Regulatory T Cells in Renal Transplant Patients a Two-year Randomized Prospective Study
Status:
COMPLETED
Status Verified Date:
2015-03
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 immune system response is mediated by the interaction between the antigen presenting cell APC CD4 T helper cells Th and CD4 CD25 regulatory T cells a subgroup of CD4 T cell which express IL-2 receptor CD25 and the transcriptional factor foxp3 Regulatory T cell may contribute to the maintenance of tolerance by suppressing the immune response to normal or tumor associated antigens
Regulatory T cell emerge from the thymus during ontogenesis and they represent about 10 of the peripheral Cd4 t cells
Rapamycin is one the most use treatment to prevent renal allograft failure Differently from calcineurin inhibitors cyclosporine and tacrolimus that inhibit T-cell activation through the inhibition of calcineurin activation rapamycin inhibits cellular proliferation by impairing the progression of the cellular cycle in particular by interaction with mTOR Recently Battaglia et al have demonstrated a Treg amplification in murine CD4 lymphocytes treated with rapamycin in vitro
Aim of the study is to evaluate the effect of different immunosuppressive regimens on regulatory T cell and to verify the hypothesis that rapamycin may induce tolerance in kidney transplanted patients more than cyclosporine treatment
Regulatory T cell emerge from the thymus during ontogenesis and they represent about 10 of the peripheral Cd4 t cells
Rapamycin is one the most use treatment to prevent renal allograft failure Differently from calcineurin inhibitors cyclosporine and tacrolimus that inhibit T-cell activation through the inhibition of calcineurin activation rapamycin inhibits cellular proliferation by impairing the progression of the cellular cycle in particular by interaction with mTOR Recently Battaglia et al have demonstrated a Treg amplification in murine CD4 lymphocytes treated with rapamycin in vitro
Aim of the study is to evaluate the effect of different immunosuppressive regimens on regulatory T cell and to verify the hypothesis that rapamycin may induce tolerance in kidney transplanted patients more than cyclosporine treatment
Detailed Description:
It is two years randomised controlled trial in parallel groups
It has been resolved to compare different immunosuppressive regimens
1 cyclosporine mycophenolateprednisone
2 rapamycin mycophenolate prednisone this treatment should be introduced after one month from renal transplantation
Patient should visited at month 1-6-12-24 from the transplant During the control we will reported the following data physical examination blood test blood count creatinin BUN immunosuppressive blood concentration histological response of surveillance renal biopsy blood pressure attendant change of current therapy pathological variation or any hospitalisation both ordinary or in DH regimen
Moreover in all control visit it will be collected a blood sample for evaluation of regulatory t cells
It has been resolved to compare different immunosuppressive regimens
1 cyclosporine mycophenolateprednisone
2 rapamycin mycophenolate prednisone this treatment should be introduced after one month from renal transplantation
Patient should visited at month 1-6-12-24 from the transplant During the control we will reported the following data physical examination blood test blood count creatinin BUN immunosuppressive blood concentration histological response of surveillance renal biopsy blood pressure attendant change of current therapy pathological variation or any hospitalisation both ordinary or in DH regimen
Moreover in all control visit it will be collected a blood sample for evaluation of regulatory t cells
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