HLA-DQ in Acute Kidney Transplantation Rejection

NCT03896919 | Completed

• 1 other identifier: HLA-DQ in kidney transplant.
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

\- Study the impact of HLA-DQ mismatch on acute rejection of Kidney transplantation

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Combined incidence of DSA or IA on peripheral blood molecular profiling

  DSA considered as a binary variable (positive or negative), with positivity based on a threshold criteria of Mean Fluorescence Intensity (MFI) approaching 1000. IA will be considered present or absent using a molecular assay.

  Baseline

Secondary Outcomes (1)

• Incidence of HLA-DQ DSA [ Time Frame: assessed at days 3,7,15,30 post transplantation

  baseline

Study Arms (2)

cases

HLA-DQ mismatched recipient-donor pairs

Diagnostic Test: HLA-DQ by luminex technology in kidney transplantation

control

HLA-DQ matched recipient- donor pairs

Diagnostic Test: HLA-DQ by luminex technology in kidney transplantation

Interventions

HLA-DQ by luminex technology in kidney transplantation DIAGNOSTIC_TEST

HLA typing (DQ) for donor and recipient using Luminex microbead method from EDTA blood sample

cases; control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be carried out on (30) renal transplant Recipient- Donor pairs who will be recruited from transplantation unit.

You may qualify if:

• The patients who will receive renal transplants.

You may not qualify if:

• Recipients with pre-transplantation desensitization protocols.
• Recipients with history of previous transplant or pregnancy.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut U

Asyut, Egypt

Location

Related Links

• Clinical issues in renal transplantation in the elderly. Clin Transplant 2015; 29: 167-175
• The association between broad antigen HLA mismatches, eplet HLA mismatches and acute rejection after kidney transplantation. Transplant Direct 2: e120, 20
• donor-specific HLA-DQ antibodies may contribute to poor graft outcome after renal transplantation. Kidney Int 82: 598-604, 2012 .

Study Officials

• sohair k sayed, prof.doctor

  clinical pathology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 1, 2019
• Study Start: May 5, 2019
• Primary Completion: May 5, 2020
• Study Completion: May 12, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

EG (1)