Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170053
Status:
COMPLETED
Last Update Posted:
2012-07-31
First Post:
2005-09-12
Brief Title:
Comparison of Sirolimus to Tacrolimus for Long Term Therapy in Kidney Transplant With no Steroids
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Randomized Trial of Thymoglobulin Induction Initial Tacrolimus and Mycophenolate Mofetil Therapy With Steroid Avoidance in Primary Kidney Transplant Recipients Followed by Continued TacrolimusMycophenolate Mofetil Therapy vs Sirolimus Mycophenolate Mofetil Therapy
Status:
COMPLETED
Status Verified Date:
2012-07
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:
Kidney transplant patients will be treated with Thymoglobulin 5 days tacrolimus Prograf and mycophenolate mofetil Cellcept from the time of transplant They will only receive steroids for 4 days and no prednisone after that At 1 month they will have a kidney biopsy and if it is ok patients will be treated long term with either continued tacrolimusmycophenolate mofetil or be switched to sirolimus Rapamunemycophenolate mofetil This will be done randomly in a manner similar to flipping a coin The investigators are trying to determine if after the initial therapy patients can stay off steroids long term and get better kidney function if they are treated with sirolimus compared to tacrolimus Patients will be followed for 3 years and will repeat kidney biopsies at 1 and 2 years after transplant
Detailed Description:
Abstract
Corticosteroids have been a mainstay of immunosuppression for kidney transplantation but they are associated with significant toxicity after long-term use Recent studies have concluded that steroid avoidance is safe and effective when combined with modern immunosuppressive maintenance therapy in low risk kidney transplant recipients These studies have included antilymphocyte induction therapy with either an anti IL-2 receptor antibody or an antithymocyte globulin such as rabbit polyclonal antithymocyte globulin Thymoglobulin Mayo Clinic Scottsdale has adopted Thymoglobulin induction tacrolimus and mycophenolate mofetil with rapid steroid taper as their standard immunosuppressive therapy in low risk patients Mayo Clinic Jacksonville is also utilizing this protocol Together both sites have utilized this approach in 64 patients Recent improvements in immunosuppressive regimens have decreased acute rejection in kidney transplant recipients and increased one-year graft survival to nearly 90 However long-term graft survival has changed little with 30 of grafts being lost to chronic allograft nephropathy CAN in the first five years after transplantation A recent paper highlighted this dilemma and demonstrated that a major cause of late CAN was chronic exposure to the nephrotoxic effects of calcineurin inhibitors CNI tacrolimus and cyclosporine and possibly cytomegalovirus infection In this study we will focus on the role of CNI in CAN We propose a prospective randomized non-blinded trial of Thymoglobulin induction with rapid steroid elimination accompanied by tacrolimus TAC and mycophenolate mofetil MMF maintenance therapy Patients are to be randomized at 1 month post-operatively to either remain on TACMMF or switch to SRLMMF The primary endpoint will be renal function at 1-year post-transplant Secondary endpoints will include renal function at 2 years post-transplant histology seen on protocol biopsies at 1 and 2 years post-transplant incidence of biopsy proven rejection at 12 months patient survival graft survival proportion of patients steroid free at 12 months infectious complications bone mineral density analysis incidence of hyperlipidemia and the incidence of new onset post-transplant diabetes mellitus
Corticosteroids have been a mainstay of immunosuppression for kidney transplantation but they are associated with significant toxicity after long-term use Recent studies have concluded that steroid avoidance is safe and effective when combined with modern immunosuppressive maintenance therapy in low risk kidney transplant recipients These studies have included antilymphocyte induction therapy with either an anti IL-2 receptor antibody or an antithymocyte globulin such as rabbit polyclonal antithymocyte globulin Thymoglobulin Mayo Clinic Scottsdale has adopted Thymoglobulin induction tacrolimus and mycophenolate mofetil with rapid steroid taper as their standard immunosuppressive therapy in low risk patients Mayo Clinic Jacksonville is also utilizing this protocol Together both sites have utilized this approach in 64 patients Recent improvements in immunosuppressive regimens have decreased acute rejection in kidney transplant recipients and increased one-year graft survival to nearly 90 However long-term graft survival has changed little with 30 of grafts being lost to chronic allograft nephropathy CAN in the first five years after transplantation A recent paper highlighted this dilemma and demonstrated that a major cause of late CAN was chronic exposure to the nephrotoxic effects of calcineurin inhibitors CNI tacrolimus and cyclosporine and possibly cytomegalovirus infection In this study we will focus on the role of CNI in CAN We propose a prospective randomized non-blinded trial of Thymoglobulin induction with rapid steroid elimination accompanied by tacrolimus TAC and mycophenolate mofetil MMF maintenance therapy Patients are to be randomized at 1 month post-operatively to either remain on TACMMF or switch to SRLMMF The primary endpoint will be renal function at 1-year post-transplant Secondary endpoints will include renal function at 2 years post-transplant histology seen on protocol biopsies at 1 and 2 years post-transplant incidence of biopsy proven rejection at 12 months patient survival graft survival proportion of patients steroid free at 12 months infectious complications bone mineral density analysis incidence of hyperlipidemia and the incidence of new onset post-transplant diabetes mellitus
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 |
|---|---|---|---|
| Wyeth 0468H-101898 | None | None | None |