Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023244
Status:
TERMINATED
Last Update Posted:
2016-10-21
First Post:
2001-08-29
Brief Title:
Steroid Withdrawal in Pediatric Kidney Transplant Recipients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Double-Blind Randomized Trial of Steroid Withdrawal in Sirolimus- and Cyclosporine-Treated Primary Transplant Recipients
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Effective August 13 2004 Unanticipated high incidence of post-transplant lymphoproliferative disorder
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 examine the effects of withdrawing steroids on graft rejection and kidney functions in kidney transplant recipients between the ages of 0 and 20 years prior to their 21st birthday
Graft survival has improved in recent years in children with kidney transplants One bad side effect of steroid maintenance therapy has been growth retardation Doctors believe steroids might be safely withdrawn in patients that are receiving other maintenance therapies If steroids are removed children might catch up in their growth and also might have fewer side effects of other kinds This study evaluates whether steroid therapy can be withdrawn in a way that does not increase graft rejection
Graft survival has improved in recent years in children with kidney transplants One bad side effect of steroid maintenance therapy has been growth retardation Doctors believe steroids might be safely withdrawn in patients that are receiving other maintenance therapies If steroids are removed children might catch up in their growth and also might have fewer side effects of other kinds This study evaluates whether steroid therapy can be withdrawn in a way that does not increase graft rejection
Detailed Description:
Children receiving kidney renal transplantation face distressing issues in post-transplantation including but not limited to growth retardation directly attributable to corticosteroids steroids It is hypothesized that robust immunosuppression with sirolimus and calcineurin inhibitors cyclosporine or tacrolimus in conjunction with induction therapy should enable successful steroid withdrawal A steroid-free environment could lessen side effects by enabling a child to achieve catch-up growth reducing the need for anti-hypertensive therapy and reducing the risk of cardiovascular disease This trial tests the objective of providing a steroid-free state without incurring the risk of increased incidence of acute transplant rejections
Patients are enrolled prior to kidney transplantation and receive standard evaluations Patients receive induction therapy with basiliximab preoperatively and on Day 4 after surgery Immunosuppressive therapy begins with sirolimus and either cyclosporine or tacrolimus on Day 1 following surgery and with corticosteroids the day of surgery Infection prophylaxis with Bactrim is begun on Day 1 after surgery and center-specific anti-cytomegalovirus CMV therapy is given for all recipients of a CMV positive kidney At 6 months post-transplantation all patients who have not had an episode of acute rejection undergo a renal graft biopsy Patients who are confirmed to be free of subclinical rejection are randomized to either undergo complete steroid withdrawal or continue maintenance on daily steroids Patients receive either steroids or placebo while continuing other immunosuppressive medications Patients are segregated into weight groups for steroid withdrawal that occurs over months 7 to 13 Any acute rejection event during withdrawal is confirmed by renal biopsy and managed with methylprednisolone treatment Patients are followed for 3 years post-transplantation for analysis of growth rate blood pressure lipid profile and renal function as measured by serum creatinine and calculated creatinine clearances Post-transplantation clinic visits are weekly for the first 2 months every 2 weeks until 13 months weekly during Month 13 every 2 weeks through Month 18 and monthly until the study ends
Patients who exhibit evidence of acute or subclinical rejection do not continue the steroid withdrawal trial and care is managed by their pediatric renal transplant center physicians
Patients are enrolled prior to kidney transplantation and receive standard evaluations Patients receive induction therapy with basiliximab preoperatively and on Day 4 after surgery Immunosuppressive therapy begins with sirolimus and either cyclosporine or tacrolimus on Day 1 following surgery and with corticosteroids the day of surgery Infection prophylaxis with Bactrim is begun on Day 1 after surgery and center-specific anti-cytomegalovirus CMV therapy is given for all recipients of a CMV positive kidney At 6 months post-transplantation all patients who have not had an episode of acute rejection undergo a renal graft biopsy Patients who are confirmed to be free of subclinical rejection are randomized to either undergo complete steroid withdrawal or continue maintenance on daily steroids Patients receive either steroids or placebo while continuing other immunosuppressive medications Patients are segregated into weight groups for steroid withdrawal that occurs over months 7 to 13 Any acute rejection event during withdrawal is confirmed by renal biopsy and managed with methylprednisolone treatment Patients are followed for 3 years post-transplantation for analysis of growth rate blood pressure lipid profile and renal function as measured by serum creatinine and calculated creatinine clearances Post-transplantation clinic visits are weekly for the first 2 months every 2 weeks until 13 months weekly during Month 13 every 2 weeks through Month 18 and monthly until the study ends
Patients who exhibit evidence of acute or subclinical rejection do not continue the steroid withdrawal trial and care is managed by their pediatric renal transplant center physicians
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