Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04835948
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2021-03-30
Brief Title:
Efficacy of Single Dose Anti-thymocyte Globulin in the Modulation of T Lymphocytes in Kidney Transplantation
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Hospital de Clinicas de Porto Alegre
Study Overview
Official Title:
Study of the Efficacy of Single Dose Anti-thymocyte Globulin in the Modulation of T Lymphocytes in Kidney Transplant Outcomes
Status:
COMPLETED
Status Verified Date:
2021-03
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 use of polyclonal anti-T cell antibodies ATG has benefits in kidney transplantation however its use is associated mainly with hematological infectious and neoplastic complications Monitoring T cells in patients receiving ATG was first proposed in 1975 to improve efficacy in preventing acute rejection and avoiding excessive immunosuppression The dose regimen is guided by a daily count of TCD3 lymphocytes Monitoring the dose of thymoglobulin through its biological effects on T cells is a rational and safe method of titrating the dose of that antibody This way it is possible to reduce the total amount of drug administered to the patient and consequently reduce undesirable complications as well as the cost of treatment without losing effect on the benefit of immunosuppression
Currently the usual cumulative dose of ATG for induction in kidney transplant patients is 6mgkg in divided doses However the ideal dose and duration of therapy are still the subject of studies with protocols between centers varying from total doses of 3 to 6 mgkg either fractionated or single to achieve the lowest dose with fewer undesirable effects and with reduced length of inpatient stay
The use of ATG in a single dose of 3 mgkg was successfully assessed for risks of infection and rejection in patients with low immunological risk
This study proposes evaluating the efficacy and safety of a single 3mgkg dose of ATG for patients with low and standard immune risk with TCD3 lymphocyte monitoring to assess the duration of the TCD3 cells in the peripheral blood
Currently the usual cumulative dose of ATG for induction in kidney transplant patients is 6mgkg in divided doses However the ideal dose and duration of therapy are still the subject of studies with protocols between centers varying from total doses of 3 to 6 mgkg either fractionated or single to achieve the lowest dose with fewer undesirable effects and with reduced length of inpatient stay
The use of ATG in a single dose of 3 mgkg was successfully assessed for risks of infection and rejection in patients with low immunological risk
This study proposes evaluating the efficacy and safety of a single 3mgkg dose of ATG for patients with low and standard immune risk with TCD3 lymphocyte monitoring to assess the duration of the TCD3 cells in the peripheral blood
Detailed Description:
Kidney transplantation is one of the major advances in medicine in the past 60 years Currently is considered the best treatment for terminal chronic kidney disease in the medium and long term and the least costly To obtain these successful outcomes the immune response to the graft must be properly controlled and monitored since its implantation T and B lymphocytes are crucial in the alloimmune response by mediating cellular and antibody-mediated rejections respectively and along with anti-HLA antibodies are the main effectors of acute and chronic rejections
Anti-thymocyte globulin ATG has a key role in the immunosuppressive induction regimens used in kidney transplants as well as in the treatment of acute rejections It is a purified solution that contains a variety of T cell-specific immunoglobulins including CD2 CD3 CD4 CD8 CD11a CD18 CD25 HLA-DR and class I HLA human leukocyte antigen This solution is produced by immunizing rabbits with human thymocytes The use of these agents is particularly important in inducing patients who are more predisposed to the nephrotoxic effects of calcineurin inhibitors CI allowing the delayed introduction of the CI Induction with antibodies is also of great value in patients with higher immunological risk such as pediatric Afro-descendants re-transplanted and previously sensitized to HLA antigens recipients
Polyclonal antibodies have definite benefits in kidney transplantation but their use is associated with hematological infectious and neoplastic complications The use of reduced doses of ATG has been the subject of recent studies but still with inconclusive results
The concept of monitoring T cells in patients receiving ATG was first proposed in 1975 to improve efficacy in preventing acute rejection and avoiding excessive immunosuppression The dose regimen is guided by a daily count of peripheral blood TCD3 lymphocytes Monitoring the dose of thymoglobulin through its biological effects on T cells is a rational and safe method of titrating the dose of that antibody This way it is possible to reduce the total amount of drug administered to the patient and consequently reduce undesirable complications as well as the cost of treatment hopefully without losing effect on the benefit of immunosuppression
A 60 reduction in the total dose of ATG and 58 reduction in therapy cost was observed in patients who were monitored using TCD3 cell counts Currently the usual total dose of ATG for induction in kidney transplant patients is 6mgkg divided into 4 doses which can be administered from day zero until day 14 maximum of transplantation However the ideal dose and duration of therapy are still the subject of investigation with protocols between centers varying from total doses of 3 to 6 mgkg fractionated or single to attempt to achieve the lowest dose with fewer undesirable effects and with reduced length of inpatient stay The use of ATG in a single dose of 3 mgkg was successfully assessed for risks of infection and rejection in patients with low immunological risk
Considering that the adverse effects associated with the use of ATG are relevant in the clinical context of kidney transplantation the use of a lower dose keeping its immunomodulatory effect with a safer profile is desirable
The study evaluates the efficacy and safety of a single dose of 3mgkg ATG for patients with low and standard immune risk with TCD3 lymphocyte monitoring to assess the clinical efficacy and the modulation of the T cell response
Anti-thymocyte globulin ATG has a key role in the immunosuppressive induction regimens used in kidney transplants as well as in the treatment of acute rejections It is a purified solution that contains a variety of T cell-specific immunoglobulins including CD2 CD3 CD4 CD8 CD11a CD18 CD25 HLA-DR and class I HLA human leukocyte antigen This solution is produced by immunizing rabbits with human thymocytes The use of these agents is particularly important in inducing patients who are more predisposed to the nephrotoxic effects of calcineurin inhibitors CI allowing the delayed introduction of the CI Induction with antibodies is also of great value in patients with higher immunological risk such as pediatric Afro-descendants re-transplanted and previously sensitized to HLA antigens recipients
Polyclonal antibodies have definite benefits in kidney transplantation but their use is associated with hematological infectious and neoplastic complications The use of reduced doses of ATG has been the subject of recent studies but still with inconclusive results
The concept of monitoring T cells in patients receiving ATG was first proposed in 1975 to improve efficacy in preventing acute rejection and avoiding excessive immunosuppression The dose regimen is guided by a daily count of peripheral blood TCD3 lymphocytes Monitoring the dose of thymoglobulin through its biological effects on T cells is a rational and safe method of titrating the dose of that antibody This way it is possible to reduce the total amount of drug administered to the patient and consequently reduce undesirable complications as well as the cost of treatment hopefully without losing effect on the benefit of immunosuppression
A 60 reduction in the total dose of ATG and 58 reduction in therapy cost was observed in patients who were monitored using TCD3 cell counts Currently the usual total dose of ATG for induction in kidney transplant patients is 6mgkg divided into 4 doses which can be administered from day zero until day 14 maximum of transplantation However the ideal dose and duration of therapy are still the subject of investigation with protocols between centers varying from total doses of 3 to 6 mgkg fractionated or single to attempt to achieve the lowest dose with fewer undesirable effects and with reduced length of inpatient stay The use of ATG in a single dose of 3 mgkg was successfully assessed for risks of infection and rejection in patients with low immunological risk
Considering that the adverse effects associated with the use of ATG are relevant in the clinical context of kidney transplantation the use of a lower dose keeping its immunomodulatory effect with a safer profile is desirable
The study evaluates the efficacy and safety of a single dose of 3mgkg ATG for patients with low and standard immune risk with TCD3 lymphocyte monitoring to assess the clinical efficacy and the modulation of the T cell response
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None