Monitoring kidney transplant rejection using blood tests
Trifecta-Kidney cfDNA-MMDx Study: Comparing the DD-cfDNA Test to MMDx Microarray Test, Central HLA Antibody Test, and Histology.
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 31 sites (Tampa, Florida and 30 other locations) |
| Trial ID | NCT04239703 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are kidney transplant recipients who are undergoing a biopsy for clinical indications.
Not a fit: Patients who decline participation, are unable to give informed consent, or are multiple organ recipients may not benefit from this study.
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 performed: Other studies have shown promise in using molecular diagnostics for transplant rejection, indicating that this approach may be effective.
Eligibility criteria
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 this trial is running
Tampa, Florida and 30 other locations
- 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)
- Detroit Medical Center, Harper University Hospital of Wayne State University — Detroit, Michigan, United States (Not_yet_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)
- 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)
- Department of Nephrology and Transplantation Medical University in Bialystok — Bialystok, Poland (Completed)
- University Hospital nr1 Bydgoszcz, Klinika Transplantologii — Bydgoszcz, Poland (Completed)
- 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)
- The Children's Memorial Health Institute, Department of Nephrology, Kidney Transplantation and Hypertension — Warsaw, Poland (Completed)
- Wroclaw Medical University, Department of Nephrology and Transplantation Medicine — Wroclaw, Poland (Recruiting)
- Department of Nephrology, University Medical Centre — Ljubljana, Slovenia (Recruiting)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.