Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007787
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2001-01-04
Brief Title:
Antibody and Delayed Cyclosporine Versus Initial Cyclosporine Alone in Patients Receiving Kidney Transplants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of Antibody Plus Delayed CSA vs CSA in Determining Delayed Graft Function in Cadaver Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2013-01
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 purpose of this study is to see if kidney function can be improved during transplants by giving the drug Thymoglobulin with delayed cyclosporine treatment instead of initial cyclosporine treatment
There have been improvements for patients receiving kidney transplants yet acute rejection is still a problem This can lead to kidney failure over time Patients whose graft fails to function properly in the first week after transplant do not do as well after 5 years as compared to patients without early problems This study will see if Thymoglobulin a drug that suppresses the immune system will improve early graft function
There have been improvements for patients receiving kidney transplants yet acute rejection is still a problem This can lead to kidney failure over time Patients whose graft fails to function properly in the first week after transplant do not do as well after 5 years as compared to patients without early problems This study will see if Thymoglobulin a drug that suppresses the immune system will improve early graft function
Detailed Description:
While graft survival of post renal transplant has improved over the last decades acute rejection remains a problem that clinical research has sought to minimize through improved strategies Graft survival prognosis is significantly worsened in patients whose allografts exhibit delayed function and patients may require early dialysis Data shows that cadaveric organ recipients requiring dialysis use in the first transplant week have a 5-year post-graft survival rate of 51 percent compared to 70 percent for those free of this complication A recent evaluation of Thymoglobulin a rabbit-derived polyclonal antibody an immunosuppressant suggests it is an effective agent worthy of further evaluation as induction therapy This trial evaluates whether a decreased DGF is seen with an improved Day 90 graft function
Recipients of a first or second cadaver kidney transplant are randomized pre-transplant to 1 of 2 treatment groups One group receives antibody therapy Thymoglobulin at the time of transplant and delayed cyclosporine therapy The other group starts cyclosporine therapy at the time of transplant without Thymoglobulin DGF is diagnosed by a less than 20 percent decrease in the serum creatinine levels in the first 24 hours post-transplant andor the need for dialysis Patients on the antibody arm receive additional antibody if they experience DGF Biopsies are performed in all cases of suspected rejection and any patient with biopsy-confirmed acute cellular rejection receives treatment Patients have regular examinations including blood tests and are evaluated for kidney function and incidence of complications for 24 months after the transplant The trial endpoint of graft function encompasses graft survival and graft function as calculated by creatinine clearance
Recipients of a first or second cadaver kidney transplant are randomized pre-transplant to 1 of 2 treatment groups One group receives antibody therapy Thymoglobulin at the time of transplant and delayed cyclosporine therapy The other group starts cyclosporine therapy at the time of transplant without Thymoglobulin DGF is diagnosed by a less than 20 percent decrease in the serum creatinine levels in the first 24 hours post-transplant andor the need for dialysis Patients on the antibody arm receive additional antibody if they experience DGF Biopsies are performed in all cases of suspected rejection and any patient with biopsy-confirmed acute cellular rejection receives treatment Patients have regular examinations including blood tests and are evaluated for kidney function and incidence of complications for 24 months after the transplant The trial endpoint of graft function encompasses graft survival and graft function as calculated by creatinine clearance
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