Antibodies and Liver Retransplantation

NCT03815864 | Unknown

• 1 other identifier: 106961
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Despite reports that associate donor specific antibody (DSA) with rejection after liver transplantation, grafts are still allocated according to blood group (ABO) but not human leukocyte antigen (HLA) compatibility, possibly due to the absence of an easily discernible clinical association between adverse recipient outcome and DSA. Re-transplantation provides a test environment where the presence of preformed DSA or other antibodies is prevalent and events (graft loss) more common so that the effect of these antibodies on outcome should be apparent. This is an observational study of routine clinical care to determine these effects on our own patients. The goal is to perfect donor-recipient matching to attain the best outcome. In addition, we may develop hypotheses and potential treatments that would be tested in further clinical trials

Conditions

Liver Transplant Failure; Antibody-mediated Rejection

Keywords

donor specific antibody; autoantibody; human leucocyte antigen

Outcome Measures

Primary Outcomes (1)

• Retransplant graft survival

  Average length of time the second liver graft remains in a living recipient regardless of function

  From date of transplantation until the date of next transplantation or date of death from any cause, whichever came first, assessed up to 240 months

Secondary Outcomes (1)

• Patient survival

  From date of transplantation until the date of death from any cause assessed up to 240 months

Other Outcomes (1)

• Acute rejection

  From date of transplantation until the date of first documented acute rejection assessed up to 240 months

Study Arms (2)

D2SA+

Median fluoresce intensity \> or = 1000 on Luminex-based solid phase assay of banked sera for anti-HLA antibodies directed against the donor of a second liver transplantation

Diagnostic Test: Luminex-based solid phase assay of banked sera for anti-HLA antibodies directed against the donor of a second liver transplantation

D2SA-

Median fluoresce intensity \< 1000 on Luminex-based solid phase assay of banked sera for anti-HLA antibodies directed against the donor of a second liver transplantation

Diagnostic Test: Luminex-based solid phase assay of banked sera for anti-HLA antibodies directed against the donor of a second liver transplantation

Interventions

Luminex-based solid phase assay of banked sera for anti-HLA antibodies directed against the donor of a second liver transplantation DIAGNOSTIC_TEST

Anti-AT1R antibodies were tested on pre-transplantation sera using ELISA kit (Lot #30, One Lambda, Canoga Park, CA)

Also known as: AT1R antibody

D2SA+; D2SA-

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients who have undergone a repeat transplantation of the liver at LHSC.

You may qualify if:

• Recipients of a second liver transplantation performed at LHSC

You may not qualify if:

• Recipients of ABO incompatible second liver transplantation
• Recipients of multiple organs

Sponsors & Collaborators

• London Health Sciences Centre: lead

Related Publications (2)

• Xu Q, McAlister VC, House AA, Molinari M, Leckie S, Zeevi A. Autoantibodies to LG3 are associated with poor long-term survival after liver retransplantation. Clin Transplant. 2021 Jul;35(7):e14318. doi: 10.1111/ctr.14318. Epub 2021 Apr 25.

  PMID: 33871888 DERIVED

• Xu Q, McAlister VC, Leckie S, House AA, Skaro A, Marotta P. Angiotensin II type I receptor agonistic autoantibodies are associated with poor allograft survival in liver retransplantation. Am J Transplant. 2020 Jan;20(1):282-288. doi: 10.1111/ajt.15571. Epub 2019 Sep 6.

  PMID: 31419065 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue samples stored for clinical use by the Transplant Laboratory since the beginning of liver transplantation at our facility in 1977

Study Officials

• Vivian McAlister

  London Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: January 24, 2019
• Study Start: January 1, 1977
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2026
• Last Updated: January 28, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: From publication until 5 years later
• Access Criteria: De-identified subject level data will be shared with researchers who contact the principal investigator, submit a research plan and sign an agreement. Approval by Western Research Ethics may be required depending on the request.