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OpenTrials
Completed

NCT Number: NCT05431712

Impact of Donor-Specific Antibodies in (Highly-) Immunized Living Donor Kidney Transplant Recipients

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Death-censored graft survival

    Time frame: 4-12 years

    Amount of patients who were alive with a functioning graft, divided by all alive included patients at different moments in time.

Secondary outcomes

  1. Patient survival

    Time frame: 4-12 years

    Amount of patients alive, divided by total amount of included patients at different moments in time.

  2. Biopsy proven rejection

    Time frame: 4-12 years

    Amount of patients with a pathologically confirmed rejection.

  3. Hospital admission days

    Time frame: first year post-transplantation

    Number of days that the patient spent admitted to the hospital.

  4. Renal function

    Time frame: first year post-transplantation

    Estimated Glomerular Filtration Rate (eGFR)

  5. Proteinuria

    Time frame: first year post-transplantation

    Grams of protein per 1 liter of urine.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Jun 24, 2022
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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