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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07006831

Acronym

Accept cfDNA

Enrollment

400

Registered

2025-06-05

Start date

2025-11-14

Completion date

2028-03-01

Last updated

2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Detection of donor-derived cell-free DNA (dd-cfDNA) from whole blood	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.

Countries

United States

Outcome results