Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005113
Status:
TERMINATED
Last Update Posted:
2012-03-13
First Post:
2000-04-14
Brief Title:
A Study to Compare Treatment With Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
An Open-Label Comparative Study of the Effect of Sirolimus Versus Standard Treatment on Clinical Outcomes and Histologic Progression of Allograft Nephropathy in High Risk Pediatric Renal Transplant Patients
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inability to meet the accrual target of 213
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 compare treatment with the new drug sirolimus SRL versus the standard treatment with cyclosporine CsA or tacrolimus in children who have received kidney transplants SRL is a new medication that may prevent the bodys immune system from rejecting organ transplants
After receiving a kidney transplant the body recognizes the donated kidney as a foreign invader and triggers the immune system to attack the kidney This can lead to rejection of the new kidney and a failed transplant To help reduce the risk of kidney rejection transplant patients are given immunosuppressant drugs which reduce the bodys normal immune response and allow the transplanted organ to function CsA or tacrolimus are two drugs that are often given to transplant patients However these are powerful drugs and it can cause serious side effects and put a patient at increased risk for infections SRL is a new drug that has been shown to reduce a transplant patients chance of rejecting a new kidney without serious side effects This study is necessary to test the safety and effectiveness of SRL in children
After receiving a kidney transplant the body recognizes the donated kidney as a foreign invader and triggers the immune system to attack the kidney This can lead to rejection of the new kidney and a failed transplant To help reduce the risk of kidney rejection transplant patients are given immunosuppressant drugs which reduce the bodys normal immune response and allow the transplanted organ to function CsA or tacrolimus are two drugs that are often given to transplant patients However these are powerful drugs and it can cause serious side effects and put a patient at increased risk for infections SRL is a new drug that has been shown to reduce a transplant patients chance of rejecting a new kidney without serious side effects This study is necessary to test the safety and effectiveness of SRL in children
Detailed Description:
Successful kidney transplantation has gradually improved over the years much of the improvement has resulted from the use of CsA However adequate and tolerable immunosuppression is difficult to achieve with CsA and rejection episodes are still frequent CsA is nephrotoxic with drug toxicity often masking rejection episodes Other immunosuppressant therapies can result in a range of complications including metabolic disturbances adrenocortical insufficiency and increased risk for infections Therefore more effective drugs with less toxicity are needed to prevent acute rejection especially in the pediatric population where the overall graft survival rate remains significantly lower when compared with that of adult transplant recipients SRL is an immunosuppressive agent being developed for the prophylaxis of acute renal allograft rejection SRL has a unique mechanism of action It inhibits T and B cell activity In Phase I and II trials in adults SRL was generally well tolerated and exhibited no apparent nephrotoxic properties and significantly lower rates of rejection were seen with SRL when compared to placebo
Patients receive extensive prestudy screening which includes a renal core biopsy chest x-ray bone density study blood tests and glomerular filtration rate GFR Patients are then randomly assigned to 1 of 2 study treatment groups in a 21 ratio 142 patients receive SRL CsAtacrolimus and corticosteroids and 71 patients receive standard CsA or tacrolimus-based double or triple drug therapy SRL is administered as an oral dose of 3 mgm2day Patients are followed for 3 years on therapy and then for 1 month of follow-up A renal core biopsy is performed at the time of study entry and at Months 6 18 and at early termination of patient in study Patients undergo physical examinations and various blood tests at specified time intervals during the 37-month study period Efficacy is assessed by comparing the composite endpoint of biopsy-proven acute rejection graft loss or death after 36 months of treatment Safety is assessed by comparing the composite endpoint of graft loss or death after 36 months of treatment
Patients receive extensive prestudy screening which includes a renal core biopsy chest x-ray bone density study blood tests and glomerular filtration rate GFR Patients are then randomly assigned to 1 of 2 study treatment groups in a 21 ratio 142 patients receive SRL CsAtacrolimus and corticosteroids and 71 patients receive standard CsA or tacrolimus-based double or triple drug therapy SRL is administered as an oral dose of 3 mgm2day Patients are followed for 3 years on therapy and then for 1 month of follow-up A renal core biopsy is performed at the time of study entry and at Months 6 18 and at early termination of patient in study Patients undergo physical examinations and various blood tests at specified time intervals during the 37-month study period Efficacy is assessed by comparing the composite endpoint of biopsy-proven acute rejection graft loss or death after 36 months of treatment Safety is assessed by comparing the composite endpoint of graft loss or death after 36 months of treatment
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 |
|---|---|---|---|
| DAIT 0468E1-217-US | None | None | None |