NCT04239703 · University of Alberta
Trifecta-Kidney cfDNA-MMDx Study
What this study is about
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies.
View original scientific description
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies.
Interventions
DIAGNOSTIC_TEST
MMDx
Portion of kidney transplant indication biopsy
DIAGNOSTIC_TEST
Prospera
Transplant patient blood sample
DIAGNOSTIC_TEST
HLA antibody
Transplant patient blood sample
Primary outcome measures
Calibration of Prospera test for T cell-mediated rejection
Time frame: 18 months
Calibration of DD-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx.
Calibration of Prospera test for antibody-mediated rejection
Time frame: 18 months
Calibration of DD-cfDNA test cut-off values against the probability of antibody-mediated rejection in the biopsy as reported by MMDx.
Calibration of Prospera test for kidney injury
Time frame: 18 months
Calibration of DD-cfDNA test cut-off values against the probability of acute and chronic kidney injury in the biopsy as reported by MMDx.
Report calibrated Prospera test results for rejection
Time frame: 6 months
Report new DD-cfDNA test cut-off values for rejection
Report calibrated Prospera test results for kidney injury
Time frame: 6 month
Report new DD-cfDNA test cut-off values for acute and chronic kidney injury
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Tampa, Florida
- Baltimore, Maryland
- Detroit, Michigan
- St Louis, Missouri
- Cleveland, Ohio
- Murray, Utah
- Richmond, Virginia
- Seattle, Washington
Collaborators
Natera, Inc., One Lambda
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations