Health TrialsbyHealthPanel

Trifecta-Kidney cfDNA-MMDx Study

ConditionKidney Transplant Rejection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Alberta

About this trial

Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients will be excluded from the study if they decline participation or are unable to give informed consent or multiple organ recipients.

Trial population

The study population includes patients with a functioning kidney transplant undergoing a biopsy for clinical indications as standard of care to determine the cause of their graft dysfunction (deterioration in graft function, delayed graft function, proteinuria).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MMDx

    Diagnostic test

    Portion of kidney transplant indication biopsy

  • Prospera

    Diagnostic test

    Transplant patient blood sample

  • HLA antibody

    Diagnostic test

    Transplant patient blood sample

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Kidney transplant biopsies for cause3 interventions

Trial outcomes

Primary outcomes

1

Calibration of Prospera test for T cell-mediated rejection

Calibration of DD-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx.

Time frame
18 months
2

Calibration of Prospera test for antibody-mediated rejection

Calibration of DD-cfDNA test cut-off values against the probability of antibody-mediated rejection in the biopsy as reported by MMDx.

Time frame
18 months
3

Calibration of Prospera test for kidney injury

Calibration of DD-cfDNA test cut-off values against the probability of acute and chronic kidney injury in the biopsy as reported by MMDx.

Time frame
18 months
4

Report calibrated Prospera test results for rejection

Report new DD-cfDNA test cut-off values for rejection

Time frame
6 months

Secondary outcomes

1

Determine if Prospera blood test can replace kidney biopsy test

Determine if Prospera test, as calibrated by this DD-cfDNA-HLA-MMDx study, will avoid need for indication biopsy when kidney transplant function deteriorates. This will be based on the consensus between participating clinicians.

Time frame
6 months
2

Assessment of donor-specific antibody status

Report and compare the DSA status based on centralized and local HLA antibody measurement.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Natera, Inc.

Collaborator

One Lambda

Collaborator

Source ClinicalTrials.gov
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