Chronic Allograft Nephropathy (CAN)/Interstitial fibrosis and Tubular Atrophy (IFTA) is responsible for most kidney transplant failures. CAN/IFTA on a 3 month kidney biopsy strongly predicts graft survival long term. CAN/IFTA remains a vexing problem for clinicians because current monitoring tools, namely the serum creatinine concentration, are not sensitive to early changes in glomerular filtration rate (GFR) or to histologic damage.
Despite advances in prevention of acute rejection (AR), it is still a significant and potentially devastating complication of solid organ transplantation. One strategy to reduce the risk of rejection is to perform kidney biopsies to detect subclinical acute rejection (SCAR) and treat to prevent progression to rejection. There is evidence that treating SCAR can prevent further immune mediated injury to the kidney, a precursor to CAN/IFTA.
Kidney biopsies provide better information but are limited due to safety concerns, patient preference and cost issues. Better, early and less invasive markers of CAN/IFTA will allow early intervention as well as improved graft and better patient outcomes.
This study seeks to validate specific proteogenomic biomarker panels for AR and CAN/IFTA in a prospective blood, urine and kidney tissue monitoring study of kidney transplant recipients who will be scheduled for standard of care biopsies.
Male and female recipients of all races, ≥18 years of age.
Patients undergoing primary or subsequent deceased-donor or living donor kidney transplantation.
Subject and/or guardian must be able to provide informed consent.
Subject and/or guardian must be able to comply with the study protocol.
Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
Recipients of previous non-renal solid organ and/or islet cell transplantation.
Infection with HIV.
Inability or unwillingness of a participant and/or guardian to provide informed consent
Patients who present for routine care kidney transplant biopsies to the Comprehensive Transplant Center and who satisfy all of the eligibility criteria are approached for this research study.
Cohort
Prospective
Not listed
Gene Expression Profiling
Full blood tube set, urine sample for proteomics and flow cytometry of urinary sediment, and an extra core kidney biopsy tissue for gene expression profiling will be collected from subjects at the time of any biopsies obtained during the study course. Whole genome expression profiling will be done using Affymetrix GeneChips at The Scripps Research Institute.
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Northwestern University
Lead sponsor
Transplant Genomics, Inc.
Collaborator
