Ignite Creation Date:
2024-05-05 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00693446
Status:
UNKNOWN
Last Update Posted:
2015-05-12
First Post:
2008-06-05
Brief Title:
A Study To Compare Sirolimus Versus Tacrolimus In De Novo Simultaneous Pancreas- Kidney Allograft Recipients Receiving An Induction Therapy With Antithymocyte Globulin Plus Mycophenolate Mofetil Plus Corticosteroids
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
An Open-Label Comparative Randomized Prospective Study To Compare Sirolimus Versus Tacrolimus In De Novo Simultaneous Pancreas- Kidney Allograft Recipients Receiving An Induction Therapy With Antithymocyte Globulin Plus Mycophenolate Mofetil Plus Corticosteroids
Status:
UNKNOWN
Status Verified Date:
2015-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Experience with tacrolimus in pancreas transplantation has become a standard for immunosuppression in almost all pancreas centers over the world Several centers have shown very good results in simultaneous pancreas-kidney SPK transplant recipients receiving antithymocyte globulin induction and maintenance immunosuppression consisting of calcineurin inhibitor and mycophenolate mofetil with or without corticosteroids
The use of sirolimus in SPK transplant patients has for the moment only been studied with good results in association with tacrolimus or cyclospsorine CsA In renal transplantation there is also evidence that sirolimus Rapamune is a potent immunosuppressant that significantly reduces the incidence of acute rejection when given with CsA effective as base therapy in the post-induction period Because of Rapamunes effectiveness and different safety profile it might be advantageous in terms of reduced nephrotoxicity to avoid completely calcineurin inhibitors without increased incidence of acute rejection
To explore this further the following study is designed to assess the use of SRL versus TAC both treatment groups including rATG plus MMF and a 3-month course of steroids in de novo simultaneous pancreas-kidney transplant recipients
The use of sirolimus in SPK transplant patients has for the moment only been studied with good results in association with tacrolimus or cyclospsorine CsA In renal transplantation there is also evidence that sirolimus Rapamune is a potent immunosuppressant that significantly reduces the incidence of acute rejection when given with CsA effective as base therapy in the post-induction period Because of Rapamunes effectiveness and different safety profile it might be advantageous in terms of reduced nephrotoxicity to avoid completely calcineurin inhibitors without increased incidence of acute rejection
To explore this further the following study is designed to assess the use of SRL versus TAC both treatment groups including rATG plus MMF and a 3-month course of steroids in de novo simultaneous pancreas-kidney transplant recipients
Detailed Description:
The main objective is to compare renal and pancreas graft survivals at 12 months after simultaneous pancreas-kidney transplantation in patients receiving either a regimen combining sirolimus SRL plus mycophenolate mofetil MMF following an antibody induction rATG or a regimen combining tacrolimus TAC plus mycophenolate mofetil following an antibody induction rATG In both regimens corticosteroids CS will be withdrawn three months after transplantation
In addition the two treatment groups will be compared for acute rejection renal and pancreas functions and patient survival after transplantation at 12 months and for a total period of 5 years of follow-up
In addition the two treatment groups will be compared for acute rejection renal and pancreas functions and patient survival after transplantation at 12 months and for a total period of 5 years of follow-up
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