Validation of genomic immune-phenotyping profiles in peripheral blood
Research type
Research Study
Full title
Validation of genomic immune-phenotyping profiles in peripheral blood gene signatures to predict risk of kidney transplant rejection
IRAS ID
296738
Contact name
Paramit Chowdhury
Contact email
Sponsor organisation
Verici Dx
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NCT04727788, ClinicalTrials.gov
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
This research study is designed to validate novel non-invasive tests to predict different types of kidney injury in people who have received a kidney transplant, thus potentially directing clinical changes to prolong the life of the transplant. The study will correlate gene expression found in blood and urine samples with different types of injury, including rejection, and kidney loss. Gene expression is the process by which the information encoded in a gene is used to direct the assembly of protein molecules which can then attack the kidney.
To address the study’s primary objectives, clinical and pathological data along with blood, biopsy tissue, (when feasible), and urine samples will be collected. Blood and urine samples will be collected from enrolled subjects during routine medical visits for transplant preparation or monitoring. They will be collected according to clinical practice norms of the participating study sites using standard clinical venipuncture blood collection tubes and urine collection containers and methods, respectively. Tissue biopsies will be collected using core biopsy collection methods for clinically indicated biopsies, and during two study-specific surveillance biopsies if they are not. The biopsies will be conducted by physicians experienced in their conduct and in accordance with the site established clinical procedures. Additional precautions include stationary follow up for 6 hours after the procedure and pre-procedure suspension of any anticoagulants/anti-platelet agents that the patients might be taking.
Patients who sign consent will be seen before transplantation, and at Months 1, 3, 6, 12 and 24 after transplant. After 24 months, patients will be followed through registry data for later development of fibrosis or for graft loss or death.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0214
Date of REC Opinion
13 Dec 2021
REC opinion
Further Information Favourable Opinion