Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000935
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
1999-11-02
Brief Title:
An Evaluation of IV Gamma Globulin As a Method to Improve Kidney Transplant Survival in Patients With End-Stage Renal Disease Who Are Highly Sensitized to Transplant Antigens
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of Intravenous Gamma Globulin IVIG As an Agent to Lower Allosensitization and Improve Allograft Survival in Highly-Sensitized Adult End-Stage Renal Disease ESRD Patients IG02
Status:
COMPLETED
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:
This study is designed to test the clinical and laboratory observations that suggest IVIG given before and after kidney transplant to patients who are sensitized highly sensitive to certain transplant antigens could result in reduced sensitization and reduced rates of kidney rejection
Some ESRD patients are highly sensitive to certain transplant antigens foreign substances that activate the immune system and must wait for a long time before a well-matched kidney becomes available Transplant rejection is more likely among highly sensitized patients than in patients who are not highly sensitized There is no proven method to improve a highly-sensitized patients chances of receiving and keeping a transplanted kidney
Some ESRD patients are highly sensitive to certain transplant antigens foreign substances that activate the immune system and must wait for a long time before a well-matched kidney becomes available Transplant rejection is more likely among highly sensitized patients than in patients who are not highly sensitized There is no proven method to improve a highly-sensitized patients chances of receiving and keeping a transplanted kidney
Detailed Description:
Kidney transplantation is the treatment of choice for patients with end-stage renal disease ESRD However many patients do not receive this treatment due to immune sensitization to HLA antigens IVIG has been shown to somewhat reduce anti-HLA antibody activity By blocking this activity IVIG may make transplants more feasible and increase graft survival in transplant recipients
Patients are randomized to receive IV infusion of either 2 gkg maximum dose 180 g IVIG 10 SD Gamimune-N 10 manufactured by Bayer or placebo 01 human albumin manufactured by Bayer at time of dialysis at study entry and monthly for 3 months If patients have not received a transplant at 1 year they receive a booster dose of IVIG or placebo patients receive another booster at 24 months if transplant still has not occurred If transplant occurs patients receive 2 gkg up to 180 g IVIG or placebo monthly for 4 months beginning at time of transplant Before and after initiation of IVIGalbumin placebo treatment specific immune parameters including panel reactive antibodies PRA levels MLR serum inhibition of MLR and cytokine gene transcription in the MLR and AECA levels are measured Outcomes studied include time on dialysis and graft survival rates
Patients are randomized to receive IV infusion of either 2 gkg maximum dose 180 g IVIG 10 SD Gamimune-N 10 manufactured by Bayer or placebo 01 human albumin manufactured by Bayer at time of dialysis at study entry and monthly for 3 months If patients have not received a transplant at 1 year they receive a booster dose of IVIG or placebo patients receive another booster at 24 months if transplant still has not occurred If transplant occurs patients receive 2 gkg up to 180 g IVIG or placebo monthly for 4 months beginning at time of transplant Before and after initiation of IVIGalbumin placebo treatment specific immune parameters including panel reactive antibodies PRA levels MLR serum inhibition of MLR and cytokine gene transcription in the MLR and AECA levels are measured Outcomes studied include time on dialysis and graft survival rates
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