A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDevyser Inc.
About this trial
The purpose of this research is to collect blood samples and data from kidney transplant patients. The samples and data will be used for research and development of non-invasive test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients to evaluate the status of the transplanted organ.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to provide written informed consent
Is 18 years of age or older at enrollment
Had a kidney transplant prior to enrollment
Is having an indication (for cause) biopsy as determined by clinician
Disqualifiers
Is pregnant
Had a blood transfusion within the past 4 weeks
Had a transplant from an identical (monozygotic) twin
Had transplants of multiple organs from the same donor (eg, kidney and liver transplant).
Trial population
Kidney Transplant Recipients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 1 trial groupGroup A: Kidney transplant recipients
Trial outcomes
Primary outcomes
1
Detection of donor-derived cell-free DNA (dd-cfDNA) from whole blood
Collected samples will be used for research and development of a noninvasive in- vitro diagnostic test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients.
Time frame
18 monthsSponsors and contacts
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Source ClinicalTrials.gov