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

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.

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Key information

Conditions

Kidney Disease Cell-free DNA Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Transplant Male Urogenital Diseases NGS Renal Function Transplant Recipient Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Health, San Diego, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

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)

Treatment and study plan

Primary outcomes

Detection of donor-derived cell-free DNA (dd-cfDNA) from whole blood

Time frame: 18 months

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.

Sponsors and collaborators

Lead sponsor

Devyser Inc.

Industry

Registry information

Acronym: Accept cfDNA

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Jun 5, 2025
Registry last updated: Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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