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NCT07006831Recruiting

A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population

Devyser Inc.

Start Date

11/14/2025

Completion Date

3/1/2027

Summary

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.

Detailed Description

This is a prospective, multicenter sample collection study within a kidney transplant population. Whole blood samples and clinical data will be obtained from each participant at the time of indication biopsy (prior to the biopsy procedure). De-identified leftover retrospective gDNA screening samples from the paired donor(s) will also be obtained.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Is 18 years of age or older at enrollment 3. Had a kidney transplant prior to enrollment 4. Is having an indication (for cause) biopsy as determined by clinician 5. retrospective leftover samples are available from the kidney donor(s). Exclusion Criteria: 1. Is pregnant 2. Had a blood transfusion within the past 4 weeks 3. Had a transplant from an identical (monozygotic) twin 4. Had transplants of multiple organs from the same donor (eg, kidney and liver transplant). 5. Had transplants of more than 2 organs from different donors (eg, recipient of a third kidney transplant) 6. Had a transplant of hematopoietic stem cells (eg, bone marrow) or tissue (eg, heart valve)

Interested in This Trial?

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Conditions

Kidney DiseaseKidney TransplantTransplant RecipientRenal FunctionCell-free DNANGS

Locations

Scripps Health

San Diego, California 92037

United States

University of California San Francisco

San Francisco, California 94143

United States

Piedmont Healthcare

Atlanta, Georgia 30309

United States

University of Maryland Baltimore

Baltimore, Maryland 21201

United States

Brigham & Women's Hospital

Boston, Massachusetts 02115

United States

University of Utah

Salt Lake City, Utah 84132

United States