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

NCT07006831 | Recruiting

• 1 other identifier: DVYUS-TDX-001
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Kidney Disease; NGS; Kidney Transplant; Transplant Recipient; Renal Function; Cell-free DNA

Outcome Measures

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.

  18 months

Study Arms (1)

Kidney transplant recipients

Kidney transplant recipients who are 18 years of age or older

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney Transplant Recipients

You may qualify if:

• 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
• retrospective leftover samples are available from the kidney donor(s).

You may not qualify if:

• 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).
• Had transplants of more than 2 organs from different donors (eg, recipient of a third kidney transplant)
• Had a transplant of hematopoietic stem cells (eg, bone marrow) or tissue (eg, heart valve)

Sponsors & Collaborators

• Devyser Inc.: lead

Study Sites (6)

Scripps Health

San Diego, California, 92037, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

RECRUITING

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

Related Publications (1)

• Pettersson L, Westerling S, Talla V, Sendel A, Wennberg L, Olsson R, Hedrum A, Hauzenberger D. Development and performance of a next generation sequencing (NGS) assay for monitoring of dd-cfDNA post solid organ transplantation. Clin Chim Acta. 2024 Jan 1;552:117647. doi: 10.1016/j.cca.2023.117647. Epub 2023 Nov 10.

  PMID: 37951377 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

plasma from whole blood specimens and gDNA

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)