NIH-funded research U01 cooperative agreement

Biomarker-guided changes in kidney transplant immunosuppression

Official title: Assessment of Biomarker Guided CNI Substitution in Kidney Transplantation

Funded at Cedars-Sinai Medical Center · NIH-11406938 · Data updated 2026-11-12

This project tests whether a biomarker score from donor and recipient immune markers can guide safer, personalized immunosuppression after kidney transplant.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionCedars-Sinai Medical Center
NIH-funded
Lab location1 site (Los Angeles, United States)
Project startJuly 1, 2022
Project endJune 30, 2029
Funding year2026
Award (this year)$4,819,483
NIH project number5U01AI170424-05
Project IDNIH-11406938 on NIH RePORTER

Who could benefit from this research

Could help

Adults who have received a kidney transplant and are on immunosuppressive therapy, with biomarker data available or obtainable.

Less likely to help

Patients without access to participating centers or who do not have the biomarker profile studied may not benefit.

What this research studies

In kidney transplant patients, current immunosuppression is broadly similar for many people, which can lead to over-immunosuppression and drug toxicities. The study will use the HLA-DR/DQ molecular mismatch score to identify patients at higher risk of rejection and immune-related injury. It includes a multicenter observational component and a nested randomized trial to see if adjusting therapy based on the biomarker improves outcomes. Researchers will collect biomarker data, monitor rejection risk, and test treatment changes in a controlled way. The goal is to tailor immunosuppression to each patient’s biological risk rather than using a one-size-fits-all approach.

Why it matters

Potential benefit: If successful, patients could receive more personalized immunosuppression with fewer side effects and better graft survival.

How similar studies have gone: Prior retrospective work linked the biomarker score to rejection risk, but this trial tests prospective use and treatment changes.

Where this research is happening

  • Cedars-Sinai Medical Center
    Los Angeles, United States
    Active

Researchers

  • Principal investigator: Heeger, Peter Scott — Cedars-Sinai Medical Center
  • Study coordinator: Heeger, Peter Scott

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.