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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04239703




Registration number
NCT04239703
Ethics application status
Date submitted
14/01/2020
Date registered
27/01/2020
Date last updated
10/09/2021

Titles & IDs
Public title
INTERCOMEX Donor-Derived Cell Free DNA Study
Scientific title
INTERCOMEX DD-cfDNA-HLA-MMDx Study: Comparing the DD-cfDNA Test to MMDx Microarray Test, Central HLA Antibody Test, and Histology.
Secondary ID [1] 0 0
ATAGC05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplant Rejection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - MMDx
Diagnosis / Prognosis - Prospera
Diagnosis / Prognosis - HLA antibody

Kidney transplant biopsies for cause - The study population includes patients with a functioning kidney transplant undergoing a biopsy for clinical indications as standard of care.


Diagnosis / Prognosis: MMDx
Portion of kidney transplant indication biopsy

Diagnosis / Prognosis: Prospera
Transplant patient blood sample

Diagnosis / Prognosis: HLA antibody
Transplant patient blood sample

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
18 months
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
18 months
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
18 months
Primary outcome [4] 0 0
Report calibrated Prospera test results for rejection - Report new DD-cfDNA test cut-off values for rejection
Timepoint [4] 0 0
6 months
Primary outcome [5] 0 0
Report calibrated Prospera test results for kidney injury - Report new DD-cfDNA test cut-off values for acute and chronic kidney injury
Timepoint [5] 0 0
6 month
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Assessment of donor-specific antibody status - Report and compare the DSA status based on centralized and local HLA antibody measurement.
Timepoint [2] 0 0
6 months

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients will be excluded from the study if they decline participation or are unable
to give informed consent.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Department of Nephrology, The Royal Melbourne Hospital 1 South East - Melbourne
Recruitment postcode(s) [1] 0 0
VIC 3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Croatia
State/province [10] 0 0
Zagreb
Country [11] 0 0
Czechia
State/province [11] 0 0
Prague
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin
Country [13] 0 0
Lithuania
State/province [13] 0 0
Vilnius
Country [14] 0 0
Poland
State/province [14] 0 0
Bialystok
Country [15] 0 0
Poland
State/province [15] 0 0
Bydgoszcz
Country [16] 0 0
Poland
State/province [16] 0 0
Gdansk
Country [17] 0 0
Poland
State/province [17] 0 0
Katowice
Country [18] 0 0
Poland
State/province [18] 0 0
Poznan
Country [19] 0 0
Poland
State/province [19] 0 0
Szczecin
Country [20] 0 0
Poland
State/province [20] 0 0
Warsaw
Country [21] 0 0
Poland
State/province [21] 0 0
Wroclaw
Country [22] 0 0
Slovenia
State/province [22] 0 0
Ljubljana
Country [23] 0 0
Switzerland
State/province [23] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Other
Name
University of Alberta
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Natera, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
One Lambda
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the
Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies.
Trial website
https://clinicaltrials.gov/show/NCT04239703
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philip F Halloran, MD, PhD
Address 0 0
University of Alberta
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Konrad S Famulski, PhD
Address 0 0
Country 0 0
Phone 0 0
1 780 492 1725
Fax 0 0
Email 0 0
konrad@ualberta.ca
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04239703