RecruitingNCT01531257

Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients


Sponsor

Northwestern University

Enrollment

1,000 participants

Start Date

Apr 1, 2010

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is monitoring kidney transplant recipients by analyzing proteins and genetic material in blood, urine, and tissue samples over time to detect early signs of rejection or other complications — with the goal of improving long-term outcomes for transplant patients. **You may be eligible if...** - You are 18 years or older, of any gender or race - You are receiving a kidney transplant for the first time or have had a previous kidney transplant - The kidney is coming from either a living donor or a deceased donor - You or your guardian can provide informed consent **You may NOT be eligible if...** - You are receiving a transplant of multiple organs at once (e.g., kidney plus liver or heart) - You have previously received a non-kidney solid organ transplant - You are unable or unwilling to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Northwestern University

Chicago, Illinois, United States

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NCT01531257


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