Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000936
Status:
TERMINATED
Last Update Posted:
2017-01-11
First Post:
1999-11-02
Brief Title:
A Study To Test An Anti-Rejection Therapy After Kidney Transplantation
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Controlled Trial of Induction Therapy in Renal Transplantation
Status:
TERMINATED
Status Verified Date:
2017-01
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:
Kidney transplantation is often successful However despite aggressive anti-rejection drug therapy some patients will reject their new kidney This study is designed to test two anti-rejection approaches Two medications in this study are currently used in children but there is no information regarding which drug is safer or more effective
Survival rates in renal transplantation are unacceptably low Therefore there is a need for an improved post-transplant treatment such as the induction therapy used in this study
Survival rates in renal transplantation are unacceptably low Therefore there is a need for an improved post-transplant treatment such as the induction therapy used in this study
Detailed Description:
Renal transplantation is recognized as the treatment of choice for children with chronic renal failure However patient and graft survival rates in young children are unacceptably low In preliminary studies OKT3 a monoclonal antibody induction therapy received post transplant has been more successful than standard immunosuppression alone in improving graft survival This study is designed to assess the impact of induction therapy on graft survival in pediatric kidney transplant patients
Patients are assigned to OKT3 induction or no induction in a 11 ratio Randomization to oral cyclosporine of either Sandimmune or Neoral is also done in a 11 ratio Group 1 receives OKT3 intraoperatively followed by Neoral Group 2 receives OKT3 intraoperatively followed by Sandimmune OKT3 is administered at 25 mg if weight less than 30 kg or 5 mg if weight above 30 kg per day for a maximum of 14 days Group 3 receives IV cyclosporine followed by Neoral Group 4 receives IV cyclosporine followed by Sandimmune Oral cyclosporine is administered in a masked preparation The dose for Sandimmune and Neoral is the same patients 6 years of age and older begin at a dose of 15 mgkgday and patients under 6 years of age receive 500 mgm2day Patients will receive concomitant medications including steroids IV and po Nifedipine anti-CMV therapy Bactrim Azathioprine or Mycophenolate Mofetil Kidney function incidence of viral infection graft survival and incidence of malignancy will be measured to assess the role of OKT3 induction and the role of rejection in graft failure Graft function will be evaluated at 1- 2- and 4-year intervals
Patients are assigned to OKT3 induction or no induction in a 11 ratio Randomization to oral cyclosporine of either Sandimmune or Neoral is also done in a 11 ratio Group 1 receives OKT3 intraoperatively followed by Neoral Group 2 receives OKT3 intraoperatively followed by Sandimmune OKT3 is administered at 25 mg if weight less than 30 kg or 5 mg if weight above 30 kg per day for a maximum of 14 days Group 3 receives IV cyclosporine followed by Neoral Group 4 receives IV cyclosporine followed by Sandimmune Oral cyclosporine is administered in a masked preparation The dose for Sandimmune and Neoral is the same patients 6 years of age and older begin at a dose of 15 mgkgday and patients under 6 years of age receive 500 mgm2day Patients will receive concomitant medications including steroids IV and po Nifedipine anti-CMV therapy Bactrim Azathioprine or Mycophenolate Mofetil Kidney function incidence of viral infection graft survival and incidence of malignancy will be measured to assess the role of OKT3 induction and the role of rejection in graft failure Graft function will be evaluated at 1- 2- and 4-year intervals
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