Functional Antigen Matching in Corneal Transplantation (FANCY)

University Hospital Freiburg

Status: Completed

Conditions: Corneal Diseases

Treatments: Procedure: Penetrating keratoplasty; Other: HLA Matching

Study type: Interventional

Funder types: Other

Identifiers

NCT00810472

FR-2008-FANCY

Details and patient eligibility

About

Penetrating keratoplasty is one of the most commonly performed transplantation surgeries. Graft rejection is a major complication. HLA compatibility has already been demonstrated an effective prophylaxis in several retrospective investigations. The purpose of the investigators randomized clinical trial is to demonstrate superiority of HLA matching in comparison to random graft assignment with respect to the endpoint 'time to first endothelial graft rejection' in penetrating keratoplasty. The investigators will perform DNA-based allele resolution typing.

Enrollment: 650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Predicted waiting time for a 4/6 match lower than 6 months.

Exclusion criteria

• Minority
• Legal incapacity

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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650 participants in 2 patient groups, including a placebo group

HLA Matching

Experimental group

Description:

HLA matching is exerted by selecting the donor with least-most additional HLA alleles. We will predict the waiting time for such a donor in order to assess eligibility for the trial \[8\]. In addition, we will dynamically adopt the degree of matching that is aimed at depending on the predicted time interval and actual waiting time: the first donors not exerting more than 7 mismatches at the triplet-amino-acid-residue-level (HLAMatchmaker method \[6\]) is accepted if the patient is waiting less than half of his predicted waiting time. The next available donor exerting a 2/6 match (or better) is assigned thereafter. The next graft will be assigned, regardless of HLA matching after 6 months.

Treatment:

Other: HLA Matching

Procedure: Penetrating keratoplasty

Random graft assignment

Placebo Comparator group

Treatment:

Procedure: Penetrating keratoplasty