Antibodies and Liver Retransplantation

Antibody-mediated Rejection Clinical Trial

Official title:

Role of Donor Specific Antibodies, Other Anti-human Leucocyte Antibodies and Autoantibodies in the Outcome of Liver Retransplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03815864
• Other study ID #: 106961
• Status: Active, not recruiting
• Start date: January 1, 1977
• Est. completion date: January 1, 2026

Study information

• Verified date: January 2019
• Source: London Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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.

In phase 1, we will examine the effect of antibodies specifically directed against the second donor in liver retransplantation. Other factors known to effect the outcome will be checked to allow for risk adjustment.

In phase 2, we will examine the role played by specific auto-antibodies such as angiotensin II receptor type 1 antibodies and endothelin-1 type A receptor antibodies on the outcome of liver retransplantation.

The goal of these observational study 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Recipients of a second liver transplantation performed at LHSC

Exclusion Criteria:

• Recipients of ABO incompatible second liver transplantation

• Recipients of multiple organs

Related Conditions & MeSH terms

• Antibody-mediated Rejection
• Liver Transplant Failure

Intervention

Diagnostic Test:
• Luminex-based solid phase assay of banked sera for anti-HLA antibodies directed against the donor of a second liver transplantation
Anti-AT1R antibodies were tested on pre-transplantation sera using ELISA kit (Lot #30, One Lambda, Canoga Park, CA)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
London Health Sciences Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute rejection	number of participants with a clinically diagnosed and treated episode of rejection (either acute cellular or humoral)	From date of transplantation until the date of first documented acute rejection assessed up to 240 months
Primary	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	Patient survival	Average length of time a recipient is alive regardless of presence of the second liver transplant	From date of transplantation until the date of death from any cause assessed up to 240 months