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Functional Antigen Matching in Corneal Transplantation (FANCY)

Primary Purpose

Corneal Diseases

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
HLA Matching
Penetrating keratoplasty
Sponsored by
University Hospital Freiburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Corneal Diseases focused on measuring Penetrating keratoplasty, HLA matching, Corneal diseases that require penetrating keratoplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Minority
  • Legal incapacity

Sites / Locations

  • University Eye Hospital Freiburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HLA Matching

Random graft assignment

Arm 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.

Outcomes

Primary Outcome Measures

Time to first endothelial graft rejection.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2008
Last Updated
October 24, 2016
Sponsor
University Hospital Freiburg
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00810472
Brief Title
Functional Antigen Matching in Corneal Transplantation
Acronym
FANCY
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 Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Freiburg
Collaborators
German Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Diseases
Keywords
Penetrating keratoplasty, HLA matching, Corneal diseases that require penetrating keratoplasty

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HLA Matching
Arm Type
Experimental
Arm 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.
Arm Title
Random graft assignment
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
HLA Matching
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Penetrating keratoplasty
Intervention Description
Corneal transplantation.
Primary Outcome Measure Information:
Title
Time to first endothelial graft rejection.
Time Frame
Mostly within the first six months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Predicted waiting time for a 4/6 match lower than 6 months. Exclusion Criteria: Minority Legal incapacity
Facility Information:
Facility Name
University Eye Hospital Freiburg
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17060851
Citation
Bohringer D, Spierings E, Enczmann J, Bohringer S, Sundmacher R, Goulmy E, Reinhard T. Matching of the minor histocompatibility antigen HLA-A1/H-Y may improve prognosis in corneal transplantation. Transplantation. 2006 Oct 27;82(8):1037-41. doi: 10.1097/01.tp.0000235908.54766.44.
Results Reference
background
PubMed Identifier
15051212
Citation
Reinhard T, Spelsberg H, Henke L, Kontopoulos T, Enczmann J, Wernet P, Berschick P, Sundmacher R, Bohringer D. Long-term results of allogeneic penetrating limbo-keratoplasty in total limbal stem cell deficiency. Ophthalmology. 2004 Apr;111(4):775-82. doi: 10.1016/j.ophtha.2003.07.013.
Results Reference
background
PubMed Identifier
15004576
Citation
Reinhard T, Bohringer D, Enczmann J, Kogler G, Mayweg S, Wernet P, Sundmacher R. Improvement of graft prognosis in penetrating normal-risk keratoplasty by HLA class I and II matching. Eye (Lond). 2004 Mar;18(3):269-77. doi: 10.1038/sj.eye.6700636.
Results Reference
background
PubMed Identifier
14966417
Citation
Bohringer D, Reinhard T, Duquesnoy RJ, Bohringer S, Enczmann J, Lange P, Claas F, Sundmacher R. Beneficial effect of matching at the HLA-A and -B amino-acid triplet level on rejection-free clear graft survival in penetrating keratoplasty. Transplantation. 2004 Feb 15;77(3):417-21. doi: 10.1097/01.TP.0000110415.10401.94.
Results Reference
background
PubMed Identifier
14738484
Citation
Reinhard T, Bohringer D, Enczmann J, Kogler G, Wernet P, Bohringer S, Sundmacher R. HLA class I/II matching and chronic endothelial cell loss in penetrating normal risk keratoplasty. Acta Ophthalmol Scand. 2004 Feb;82(1):13-8. doi: 10.1046/j.1600-0420.2003.00188.x.
Results Reference
background
PubMed Identifier
12494680
Citation
Bohringer D, Reinhard T, Enczmann J, Godehard E, Sundmacher R. Individual analysis of expected time on the waiting list for HLA-matched corneal grafts. Dev Ophthalmol. 2003;36:50-5. doi: 10.1159/000067648.
Results Reference
background
PubMed Identifier
29735006
Citation
Bohringer D, Grotejohann B, Ihorst G, Reinshagen H, Spierings E, Reinhard T. Rejection Prophylaxis in Corneal Transplant. Dtsch Arztebl Int. 2018 Apr 13;115(15):259-265. doi: 10.3238/arztebl.2018.0259.
Results Reference
derived
PubMed Identifier
25496165
Citation
Bohringer D, Ihorst G, Grotejohann B, Maurer J, Spierings E, Reinhard T; FANCY study group. Functional antigen matching in corneal transplantation: matching for the HLA-A, -B and -DRB1 antigens (FANCY) - study protocol. BMC Ophthalmol. 2014 Dec 13;14:156. doi: 10.1186/1471-2415-14-156.
Results Reference
derived

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Functional Antigen Matching in Corneal Transplantation

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