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Functional Antigen Matching in Corneal Transplantation (FANCY)

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ClinicalTrials.gov Identifier: NCT00810472
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Corneal Diseases Other: HLA Matching Procedure: Penetrating keratoplasty

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Clinical Trial to Investigate Superiority of HLA Matching in Comparison to Random Graft Assignment With Respect to the Endpoint 'Time to First Endothelial Graft Rejection' in Penetrating Keratoplasty.
Study Start Date : September 2009
Primary Completion Date : May 2015
Study Completion Date : May 2015

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: HLA Matching
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.
Other: HLA Matching
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.
Procedure: Penetrating keratoplasty
Corneal transplantation.
Placebo Comparator: Random graft assignment Procedure: Penetrating keratoplasty
Corneal transplantation.


Outcome Measures

Primary Outcome Measures :
  1. Time to first endothelial graft rejection. [ Time Frame: Mostly within the first six months. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Minority
  • Legal incapacity
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810472


Locations
Germany
University Eye Hospital Freiburg
Freiburg, Baden-Württemberg, Germany, 79106
Sponsors and Collaborators
University Hospital Freiburg
German Research Foundation
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Böhringer, Apl.Prof.Dr.med., University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT00810472     History of Changes
Other Study ID Numbers: FR-2008-FANCY
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by Daniel Böhringer, University Hospital Freiburg:
Penetrating keratoplasty
HLA matching
Corneal diseases that require penetrating keratoplasty

Additional relevant MeSH terms:
Corneal Diseases
Eye Diseases