Status:
COMPLETED
Efficacy of Single Dose Anti-thymocyte Globulin in the Modulation of T Lymphocytes in Kidney Transplantation
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Conditions:
Kidney Transplant; Complications
Immunosuppression
Eligibility:
All Genders
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. Monitorin...
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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 20 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 13 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04835948
Start Date
October 20 2018
End Date
April 13 2021
Last Update
April 19 2021
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil