Functional Antigen Matching in Corneal Transplantation (FANCY)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Daniel Böhringer, University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00810472
First received: December 17, 2008
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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 Intervention
Corneal Diseases
Other: HLA Matching
Procedure: Penetrating keratoplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Time to first endothelial graft rejection. [ Time Frame: Mostly within the first six months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: September 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810472

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

Publications:
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
Study First Received: December 17, 2008
Last Updated: July 5, 2013
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014