Clinical trial NCT05431712: Impact of Donor-Specific Antibodies in (Highly-) Immunized Living Donor Kidney Transplant Recipients
Official title: Impact of Donor-Specific Antibodies in (Highly-) Immunized Living Donor Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Failure
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive kidney transplant recipients in the period 2010-2019, who had pre-transplantation donor-specific antibodies detected in Luminex Single Antigen Bead analysis.

Brief summary: Kidney transplantation is the preferred treatment for end-stage renal disease. Alongside limited availability of donors, rejection and premature graft loss are main barriers to kidney transplantation. Donor-specific antibodies pre-transplantation may arise due to to prior solid organ transplantation, pregnancy or blood transfusions. Their presence is considered a risk of graft failure. The impact of DSA is differently reported in literature, also according to the technique by which DSA have been measured. Techniques such as the complement-dependent cytotoxicity crossmatch, the immunofluorescence crossmatch and the Luminex Single Antigen Bead have different sensitivities for detecting DSA.

Historically, our kidney transplant program has been advocating living donor transplantation and as a result the majority of transplantations are with a living donor. In this context and in the absence of a compatible living donor, pretransplant DSA have not been considered an absolute contra-indication for transplantation. The aim of the current study is to determine the effect of DSAs on rejection and death-censored graft survival in living donor kidney transplantation.

Participants are adults who underwent a living donor kidney transplantation between 2010 and 2019 in the presence of DSA. Control subjects are both immunized and non-immunized kidney transplant recipients in the same period.

This is a retrospective, case control study. Death-censored graft survival is analyzed for all patients and compared by presence of DSA and other predicting variables, such as immunization level, age, sex and HLA mismatches. Furthermore, biopsy proven rejection, patient survival, kidney function, length of hospital stay and proteinuria are analyzed.

Also, a predefined subgroup analysis is performed in the DSA positive patients. These are compared according to amount, strength and HLA-class of DSAs.


Eligibility criteria: Inclusion Criteria:

* Pre-transplantation donor-specific antibodies in Luminex Single Antigen Bead analysis.
* Age 18 years or older

Exclusion Criteria:

* Desensitization treatment for a current or historic positive CDC-crossamtch

Primary outcomes:
measure: Death-censored graft survival
timeFrame: 4-12 years
Secondary outcomes:
measure: Patient survival
timeFrame: 4-12 years
measure: Biopsy proven rejection
timeFrame: 4-12 years
measure: Hospital admission days
timeFrame: first year post-transplantation
measure: Renal function
timeFrame: first year post-transplantation
measure: Proteinuria
timeFrame: first year post-transplantation
Other outcomes:
Locations:
Study officials:
References:
citation: Chung BH, Choi BS, Oh EJ, Park CW, Kim JI, Moon IS, Kim YS, Yang CW. Clinical impact of the baseline donor-specific anti-human leukocyte antigen antibody measured by Luminex single antigen assay in living donor kidney transplant recipients after desensitization therapy. Transpl Int. 2014 Jan;27(1):49-59. doi: 10.1111/tri.12199. Epub 2013 Oct 25.
citation: Betjes MGH, Sablik KS, Otten HG, Roelen DL, Claas FH, de Weerd A. Pretransplant Donor-Specific Anti-HLA Antibodies and the Risk for Rejection-Related Graft Failure of Kidney Allografts. J Transplant. 2020 Jan 29;2020:5694670. doi: 10.1155/2020/5694670. eCollection 2020.
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