Using an HLA donor–recipient gene-mismatch score to guide switching anti-rejection drugs after kidney transplant
Assessment of Biomarker Guided CNI Substitution in Kidney Transplantation
['FUNDING_U01'] · CEDARS-SINAI MEDICAL CENTER · NIH-11143086
This project tests whether an HLA-DR/DQ gene-mismatch score can help doctors safely move some kidney transplant patients off tacrolimus onto alternative immunosuppression.
Quick facts
| Phase | ['FUNDING_U01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | CEDARS-SINAI MEDICAL CENTER (nih funded) |
| Locations | 1 site (LOS ANGELES, UNITED STATES) |
| Trial ID | NIH-11143086 on ClinicalTrials.gov |
What this research studies
You would have an HLA-DR/DQ molecular mismatch score calculated from your donor–recipient match and be followed closely for kidney function, biopsies, and donor-specific antibodies. The study combines an observational registry with a nested randomized trial where some patients (based on their biomarker risk) may be randomly assigned to switch from a calcineurin inhibitor like tacrolimus to another regimen. Clinicians will monitor for biopsy-proven rejection, antibody development, drug side effects, and overall graft outcomes. The work is done at multiple transplant centers using centralized biomarker testing and established trial infrastructure.
Who could benefit from this research
Good fit: Ideal candidates are adult kidney transplant recipients who are stable on calcineurin inhibitor–based therapy and are willing to have biomarker testing and regular follow-up including possible biopsies.
Not a fit: People with very high immunologic risk, recent or ongoing rejection, multi-organ transplants, or those unable to attend follow-up visits or biopsies may not benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could personalize immunosuppression, reduce tacrolimus-related toxicities, and help preserve long-term kidney graft function.
How similar studies have performed: Retrospective studies showed strong links between the HLA-DR/DQ molecular mismatch score and rejection or donor-specific antibodies, but no prior prospective randomized trial has tested biomarker-guided calcineurin inhibitor substitution.
Where this research is happening
LOS ANGELES, UNITED STATES
- CEDARS-SINAI MEDICAL CENTER — LOS ANGELES, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: HEEGER, PETER SCOTT — CEDARS-SINAI MEDICAL CENTER
- Study coordinator: HEEGER, PETER SCOTT
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.