Monitoring kidney transplant rejection using blood tests
Official title: Trifecta-Kidney cfDNA-MMDx Study: Comparing the DD-cfDNA Test to MMDx Microarray Test, Central HLA Antibody Test, and Histology.
Run by University of Alberta · NCT04239703 · Data updated 2026-11-12
This study is testing if measuring certain DNA levels in the blood can help doctors better detect kidney transplant rejection in patients who are already having biopsies.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | University of Alberta Academic / other |
| Locations | 31 sites (Tampa, Florida and 30 other locations) |
| Status | Recruiting |
| Started | December 1, 2019 |
| Main results expected | December 2028 |
| Study ends | December 2029 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT04239703 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are kidney transplant recipients who are undergoing a biopsy for clinical indications.
✕Probably not a fit
Patients who decline participation, are unable to give informed consent, or are multiple organ recipients may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the relationship between donor-derived cell-free DNA (DD-cfDNA) levels and HLA antibodies in the blood of kidney transplant recipients. It seeks to improve the detection of kidney transplant rejection by utilizing the Molecular Microscope® Diagnostic System (MMDx) alongside the Prospera® test, which quantifies DD-cfDNA through advanced sequencing techniques. The study will involve kidney transplant patients who are undergoing biopsies for clinical reasons, allowing for a comprehensive assessment of rejection and injury. By comparing traditional methods with molecular diagnostics, the study hopes to enhance the accuracy of rejection detection.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely detection of kidney transplant rejection, improving patient outcomes.
How similar studies have gone: Other studies have shown promise in using molecular diagnostics for transplant rejection, indicating that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All kidney transplant recipients undergoing a kidney biopsy for clinical indications, as determined by their physician or surgeon, will be eligible to enroll in the study. Exclusion Criteria: * Patients will be excluded from the study if they decline participation or are unable to give informed consent or multiple organ recipients.
Where it's running
-
Tampa General Hospital
Tampa, Florida, United States Recruiting -
University of Maryland School of Medicine
Baltimore, Maryland, United States Recruiting -
The Johns Hopkins University, School of Medicine
Baltimore, Maryland, United States Recruiting -
Henry Ford Hospital
Detroit, Michigan, United States Recruiting -
Barnes-Jewish Hospital, Washington University at St. Louis
St Louis, Missouri, United States Recruiting -
University Hospitals Cleveland Medical Ctr.
Cleveland, Ohio, United States Recruiting
Show 25 more locations
-
Cleveland Clinic
Cleveland, Ohio, United States Recruiting -
Intermountain Transplant Services
Murray, Utah, United States Recruiting -
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States Recruiting -
Division of Nephrology & UW Organ Transplant Center University of Washington
Seattle, Washington, United States Recruiting -
Department of Nephrology, The Royal Melbourne Hospital 1 South East
Melbourne, Australia Recruiting -
University of Alberta, Department of Medicine
Edmonton, Alberta, Canada Recruiting -
ST. Paul's Hospital, 6A Providence Building, 1081 Burrard Street
Vancouver, British Columbia, Canada Recruiting -
University Hospital Merkur Renal Division
Zagreb, Croatia Recruiting -
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia Recruiting -
Charite-Medical University of Berlin Department of Nephrology
Berlin, Germany Recruiting -
Centre of Nephrology, Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania Recruiting -
Medical University of Gdańsk Klinika Nefrologii Transplantologii i Chorób Wewnętrznych
Gdansk, Poland Recruiting -
Medical University of Silesia
Katowice, Poland Recruiting -
Department of Transplantation and General Surgery, Wojewodzki Hospital
Poznan, Poland Recruiting -
Department of Nephrology, Transplantation and Internal Medicine, University Hospital n.2
Szczecin, Poland Recruiting -
Pomeranian Medical University, Samodzielny Publiczny Woj. Szpital Zespolony, Oddzial Nefrologii i Transplantacji Nerek
Szczecin, Poland Recruiting -
Medical University of Warsaw, Department of Transplantation Medicine, Nephrology and Internal Diseases
Warsaw, Poland Recruiting -
Transplant Medicine & Nephrology Clinic, Medical University of Warsaw
Warsaw, Poland Recruiting -
Wroclaw Medical University, Department of Nephrology and Transplantation Medicine
Wroclaw, Poland Recruiting -
Department of Nephrology, University Medical Centre
Ljubljana, Slovenia Recruiting -
Detroit Medical Center, Harper University Hospital of Wayne State University
Detroit, Michigan, United States Not yet recruiting -
Department of Nephrology and Transplantation Medical University in Bialystok
Bialystok, Poland Completed -
University Hospital nr1 Bydgoszcz, Klinika Transplantologii
Bydgoszcz, Poland Completed -
The Children's Memorial Health Institute, Department of Nephrology, Kidney Transplantation and Hypertension
Warsaw, Poland Completed -
University Hospital Zurich
Zurich, Switzerland Completed
Study contacts
- Principal investigator: Philip F Halloran, MD, PhD — University of Alberta
- Study coordinator: Konrad S Famulski, PhD
- Email: konrad@ualberta.ca
- Phone: 1 780 492 1725
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Belimumab to mobilize memory B cells to help delistings for highly sensitized kidney transplant candidates
A short belimumab course is being tested to see if it can reveal memory B cells that target donor HLAs, helping to decide which donors to exclude and potentially speed up getting a transplant for highly sensitized patients.
-
Frexalimab versus tacrolimus to prevent kidney transplant rejection
This trial will test whether frexalimab injections given for up to five years work as well and are as safe as tacrolimus capsules at preventing rejection in adults getting their first kidney transplant who have low-to-moderate immune risk.
-
Platelet aggregation for diagnosing acute kidney transplant rejection
This study will test whether changes in platelet activation measured from blood can help detect acute rejection in adult kidney transplant recipients.
-
Donor-Derived Cell-Free DNA Test for Monitoring Kidney Transplants
This test will try whether a blood-based donor-derived cell-free DNA (dd-cfDNA) assay can detect rejection in adults who have received a kidney transplant.
-
CRISPR-edited donor kidney transplant to reduce rejection risk
This trial will see if donor kidneys edited with CRISPR to turn off key HLA genes can lower rejection in adults with end-stage kidney disease receiving transplants.
-
Tocilizumab plus standard therapy for chronic antibody-mediated rejection after kidney transplant
This trial will try adding tocilizumab to standard treatment (plasmapheresis, IVIG, and rituximab) to see if it helps people with chronic active antibody-mediated rejection of a kidney transplant.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.