Kidney Transplant; ComplicationsNCT04835948
Efficacy of Single Dose Anti-thymocyte Globulin in the Modulation of T Lymphocytes in Kidney Transplantation
An observational study of Kidney Transplant; Complications and Immunosuppression, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplant; Complications, Immunosuppression
- What is being tested?
- single dose of Anti-thymocyte globulin
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Oct 2018to 13 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of patients who received a kidney transplant at a single institution between October 2018 and March 2020 and received ATG at a single dose of 3 mg/kg for induction of immunosuppression in the immediate postoperative period and a control group that received fractionated doses of 1.5 mg/kg adding up to a total of 6 mg/kg.
Who may be able to join
- Kidney transplant patients from Hospital de Clínicas de Porto Alegre (HCPA) between October 2018 to March 2020 who received a single 3 mg/kg ATG dose at the immediate postoperative period. Recipients of standard and low immunological risk (PRA - panel reactive antibodies <50% and without donor-specific antibodies), regardless of the time of cold ischemia and the presence of kidney failure in the donor.
- Control group consisting of patients from the same and previous period, who received fractionated ATG dosing up to 6 mg/kg total dose.
Who cannot join
- Patients who used other induction strategies that did not include ATG in a single dose of 3 mg/kg or the fractionated dose of 6 mg/kg.
- Patients who died within 24 hours after transplantation.
- Patients who had a transplant nephrectomy within 24 hours after transplantation.
- Pediatric recipients (< 14 years old).
- Recipients with incomplete data.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official title: Study of the Efficacy of Single Dose Anti-thymocyte Globulin in the Modulation of T Lymphocytes in Kidney Transplant Outcomes
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 6mg/kg, 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 mg/kg, either fractionated or single, to achieve the lowest dose with fewer undesirable effects, and with reduced length of inpatient stay.
Read more
The use of ATG in a single dose of 3 mg/kg 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 3mg/kg 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.
Read the 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 6mg/kg, 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 mg/kg, 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 mg/kg 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 3mg/kg 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.
- Being tested
- single dose of Anti-thymocyte globulin
- Keywords
- Immunosuppression, kidney transplantation, CD3+ T lymphocytes, Anti-thymocyte globulin, Rejection
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single dose of Anti-thymocyte globulinDrug
Used anti-thymocyte globulin (ATG) in a single dose of 3 mg/kg for immunosuppression induction in the immediate postoperative period
| Study group | Role | What they receive |
|---|---|---|
| Multiple doses of anti-thymocyte globulin (ATG) | Control group that received fractionated doses of 1.5 mg/kg adding up to a total of 6 mg/kg Receives: Drug: single dose of Anti-thymocyte globulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunomodulatory effect
Immunomodulatory effect of a single dose of 3mg/kg ATG on TCD3+ lymphocytes in kidney transplant patients by comparing it with the effect of the regular fractionated dose of 6 mg/kg by counting daily the number of TCD3+ lymphocytes in peripheral blood.
Measured: one year
Secondary outcomes (5)
Incidence of acute rejection
Number of patients with acute rejection diagnosed by renal biopsy with the single-dose ATG strategy.
Measured: one year
Occurence of cytomegalovirus infection
Number of patients with cytomegalovirus infection (positive detection through polymerase chain reaction or active disease).
Measured: One year
Incidence of delayed graft function
Number of patients with delayed graft function (DGF) through the number of dialysis needed in the first week after kidney transplantation.
Measured: one year
One year survival of kidney grafts
Survival of kidney grafts at 1 year after receiving a single dose of ATG.
Measured: One year
One year survival graft grafts
Patient survival at the end of 1 year of a single dose of ATG.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start20 Oct 2018
- Primary completion31 Mar 2020
- Study completion13 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabiani Palagi Machado, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835948
- Sponsor's protocol ID
- 38361620.0.0000.5327
- Status last verified
- Mar 2021
- First submitted
- 30 Mar 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nankivell BJ, Alexander SI. Rejection of the kidney allograft. N Engl J Med. 2010 Oct 7;363(15):1451-62. doi: 10.1056/NEJMra0902927. No abstract available.
PubMed 20925547Taylor DO, Kfoury AG, Pisani B, Hammond EH, Renlund DG. Antilymphocyte-antibody prophylaxis: review of the adult experience in heart transplantation. Transplant Proc. 1997 Dec;29(8A):13S-15S. doi: 10.1016/s0041-1345(97)00849-x. No abstract available.
PubMed 9414668First MR. Immunologically high-risk recipient strategies. Transplant Proc. 1999 Feb-Mar;31(1-2):243-6. doi: 10.1016/s0041-1345(98)01520-6. No abstract available.
PubMed 10083093Clesca P, Dirlando M, Park SI, Garcia R, Ferraz E, Pinheiro-Machado PG, Kushnaroff L, Tedesco-Silva H Jr, Medina-Pestana JO. Thymoglobulin and rate of infectious complications after transplantation. Transplant Proc. 2007 Mar;39(2):463-4. doi: 10.1016/j.transproceed.2007.01.024.
PubMed 17362760Gaber AO, Knight RJ, Patel S, Gaber LW. A review of the evidence for use of thymoglobulin induction in renal transplantation. Transplant Proc. 2010 Jun;42(5):1395-400. doi: 10.1016/j.transproceed.2010.04.019.
PubMed 20620442Djamali A, Turc-Baron C, Portales P, Leverson G, Chong G, Clot J, Mourad G. Low dose antithymocyte globulins in renal transplantation: daily versus intermittent administration based on T-cell monitoring. Transplantation. 2000 Mar 15;69(5):799-805. doi: 10.1097/00007890-200003150-00021.
PubMed 10755529Thiyagarajan UM, Ponnuswamy A, Bagul A. Thymoglobulin and its use in renal transplantation: a review. Am J Nephrol. 2013;37(6):586-601. doi: 10.1159/000351643. Epub 2013 Jun 12.
PubMed 23774740Alangaden GJ, Thyagarajan R, Gruber SA, Morawski K, Garnick J, El-Amm JM, West MS, Sillix DH, Chandrasekar PH, Haririan A. Infectious complications after kidney transplantation: current epidemiology and associated risk factors. Clin Transplant. 2006 Jul-Aug;20(4):401-9. doi: 10.1111/j.1399-0012.2006.00519.x.
PubMed 16842513Yang JW, Wang JN, Men TY, Zhang XM, Li XD, Shen B, Li GY, Chen DD. Comparison of clinical outcome of low-dose and high-dose rabbit antithymocyte globulin induction therapy in renal transplantation: a single-center experience. Ann Transplant. 2014 Jun 6;19:277-82. doi: 10.12659/AOT.890069.
PubMed 24906405Bishop G, Cosimi AB, Voynow NK, Whelchel JD, Wortis HH. Effect of immunosuppressive therapy for renal allografts on the number of circulating sheep red blood cells rosetting cells. Transplantation. 1975 Aug;20(2):123-9. doi: 10.1097/00007890-197508000-00005.
PubMed 1101478Wang CJ, Tuffaha A, Zhang D, Diederich DA, Wetmore JB. A CD3+ count-based thymoglobulin induction regimen permits delayed introduction of calcineurin inhibitors in kidney transplantation. Clin Transplant. 2012 Nov-Dec;26(6):900-9. doi: 10.1111/j.1399-0012.2012.01656.x. Epub 2012 Jun 4.
PubMed 22672562Peddi VR, Bryant M, Roy-Chaudhury P, Woodle ES, First MR. Safety, efficacy, and cost analysis of thymoglobulin induction therapy with intermittent dosing based on CD3+ lymphocyte counts in kidney and kidney-pancreas transplant recipients. Transplantation. 2002 May 15;73(9):1514-8. doi: 10.1097/00007890-200205150-00025.
PubMed 12023634Abouna GM, al-Abdullah IH, Kelly-Sullivan D, Kumar MS, Loose J, Phillips K, Yost S, Seirka D. Randomized clinical trial of antithymocyte globulin induction in renal transplantation comparing a fixed daily dose with dose adjustment according to T cell monitoring. Transplantation. 1995 Jun 15;59(11):1564-8.
PubMed 7778170Uber WE, Uber LA, VanBakel AB, Crumbley AJ 3rd, Pereira NL, Ikonomidis JS, Feldman DS. CD3 monitoring and thymoglobulin therapy in cardiac transplantation: clinical outcomes and pharmacoeconomic implications. Transplant Proc. 2004 Dec;36(10):3245-9. doi: 10.1016/j.transproceed.2004.11.099.
PubMed 15686739Krasinskas AM, Kreisel D, Acker MA, Bavaria JE, Pochettino A, Kotloff RM, Arcasoy S, Blumenthal N, Kamoun M, Moore JS, Rosengard BR. CD3 monitoring of antithymocyte globulin therapy in thoracic organ transplantation. Transplantation. 2002 Apr 27;73(8):1339-41. doi: 10.1097/00007890-200204270-00026.
PubMed 11981432
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of Single Dose Anti-thymocyte Globulin in the Modulation of T Lymphocytes in Kidney Transplant Outcomes
- ClinicalTrials.gov ID
- NCT04835948
- Acronym / sponsor ID
- 38361620.0.0000.5327
- Keywords
- Immunosuppression, kidney transplantation, CD3+ T lymphocytes, Anti-thymocyte globulin, Rejection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 6mg/kg, 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 mg/kg, 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 mg/kg 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 3mg/kg 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 6mg/kg, 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 mg/kg, 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 mg/kg 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 3mg/kg 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple doses of anti-thymocyte globulin (ATG) | – | Drug: single dose of Anti-thymocyte globulinControl group that received fractionated doses of 1.5 mg/kg adding up to a total of 6 mg/kg |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of patients who received a kidney transplant at a single institution between October 2018 and March 2020 and received ATG at a single dose of 3 mg/kg for induction of immunosuppression in the immediate postoperative period and a control group that received fractionated doses of 1.5 mg/kg adding up to a total of 6 mg/kg.
Key inclusion criteria (2 listed)
- Kidney transplant patients from Hospital de Clínicas de Porto Alegre (HCPA) between October 2018 to March 2020 who received a single 3 mg/kg ATG dose at the immediate postoperative period. Recipients of standard and low immunological risk (PRA - panel reactive antibodies <50% and without donor-specific antibodies), regardless of the time of cold ischemia and the presence of kidney failure in the donor.
- Control group consisting of patients from the same and previous period, who received fractionated ATG dosing up to 6 mg/kg total dose.
Key exclusion criteria (5 listed)
- Patients who used other induction strategies that did not include ATG in a single dose of 3 mg/kg or the fractionated dose of 6 mg/kg.
- Patients who died within 24 hours after transplantation.
- Patients who had a transplant nephrectomy within 24 hours after transplantation.
- Pediatric recipients (< 14 years old).
- Recipients with incomplete data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single dose of Anti-thymocyte globulinUsed anti-thymocyte globulin (ATG) in a single dose of 3 mg/kg for immunosuppression induction in the immediate postoperative period | Drug | Multiple doses of anti-thymocyte globulin (ATG) |
Primary outcome
Immunomodulatory effect
Time frame: one year
Immunomodulatory effect of a single dose of 3mg/kg ATG on TCD3+ lymphocytes in kidney transplant patients by comparing it with the effect of the regular fractionated dose of 6 mg/kg by counting daily the number of TCD3+ lymphocytes in peripheral blood.
5 secondary outcomes
Incidence of acute rejection
Time frame: one year
Occurence of cytomegalovirus infection
Time frame: One year
Incidence of delayed graft function
Time frame: one year
One year survival of kidney grafts
Time frame: One year
One year survival graft grafts
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Background: PubMed 20925547Nankivell BJ, Alexander SI. Rejection of the kidney allograft. N Engl J Med. 2010 Oct 7;363(15):1451-62. doi: 10.1056/NEJMra0902927. No abstract available.
- Background: PubMed 9414668Taylor DO, Kfoury AG, Pisani B, Hammond EH, Renlund DG. Antilymphocyte-antibody prophylaxis: review of the adult experience in heart transplantation. Transplant Proc. 1997 Dec;29(8A):13S-15S. doi: 10.1016/s0041-1345(97)00849-x. No abstract available.
- Background: PubMed 10083093First MR. Immunologically high-risk recipient strategies. Transplant Proc. 1999 Feb-Mar;31(1-2):243-6. doi: 10.1016/s0041-1345(98)01520-6. No abstract available.
- Background: PubMed 17362760Clesca P, Dirlando M, Park SI, Garcia R, Ferraz E, Pinheiro-Machado PG, Kushnaroff L, Tedesco-Silva H Jr, Medina-Pestana JO. Thymoglobulin and rate of infectious complications after transplantation. Transplant Proc. 2007 Mar;39(2):463-4. doi: 10.1016/j.transproceed.2007.01.024.
- Background: PubMed 20620442Gaber AO, Knight RJ, Patel S, Gaber LW. A review of the evidence for use of thymoglobulin induction in renal transplantation. Transplant Proc. 2010 Jun;42(5):1395-400. doi: 10.1016/j.transproceed.2010.04.019.
- Background: PubMed 10755529Djamali A, Turc-Baron C, Portales P, Leverson G, Chong G, Clot J, Mourad G. Low dose antithymocyte globulins in renal transplantation: daily versus intermittent administration based on T-cell monitoring. Transplantation. 2000 Mar 15;69(5):799-805. doi: 10.1097/00007890-200003150-00021.
- Background: PubMed 23774740Thiyagarajan UM, Ponnuswamy A, Bagul A. Thymoglobulin and its use in renal transplantation: a review. Am J Nephrol. 2013;37(6):586-601. doi: 10.1159/000351643. Epub 2013 Jun 12.
- Background: PubMed 16842513Alangaden GJ, Thyagarajan R, Gruber SA, Morawski K, Garnick J, El-Amm JM, West MS, Sillix DH, Chandrasekar PH, Haririan A. Infectious complications after kidney transplantation: current epidemiology and associated risk factors. Clin Transplant. 2006 Jul-Aug;20(4):401-9. doi: 10.1111/j.1399-0012.2006.00519.x.
- Background: PubMed 24906405Yang JW, Wang JN, Men TY, Zhang XM, Li XD, Shen B, Li GY, Chen DD. Comparison of clinical outcome of low-dose and high-dose rabbit antithymocyte globulin induction therapy in renal transplantation: a single-center experience. Ann Transplant. 2014 Jun 6;19:277-82. doi: 10.12659/AOT.890069.
- Background: PubMed 1101478Bishop G, Cosimi AB, Voynow NK, Whelchel JD, Wortis HH. Effect of immunosuppressive therapy for renal allografts on the number of circulating sheep red blood cells rosetting cells. Transplantation. 1975 Aug;20(2):123-9. doi: 10.1097/00007890-197508000-00005.
- Background: PubMed 22672562Wang CJ, Tuffaha A, Zhang D, Diederich DA, Wetmore JB. A CD3+ count-based thymoglobulin induction regimen permits delayed introduction of calcineurin inhibitors in kidney transplantation. Clin Transplant. 2012 Nov-Dec;26(6):900-9. doi: 10.1111/j.1399-0012.2012.01656.x. Epub 2012 Jun 4.
- Background: PubMed 12023634Peddi VR, Bryant M, Roy-Chaudhury P, Woodle ES, First MR. Safety, efficacy, and cost analysis of thymoglobulin induction therapy with intermittent dosing based on CD3+ lymphocyte counts in kidney and kidney-pancreas transplant recipients. Transplantation. 2002 May 15;73(9):1514-8. doi: 10.1097/00007890-200205150-00025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant; Complications and Immunosuppression, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunomodulatory effect (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04835948, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021; AzTrials last refreshed its copy on 26 Oct 2026.