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RecruitingNCT07006831Accept cfDNAUpdated Aug 21, 2026

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

An observational study in Kidney Disease, Kidney Transplant and Transplant Recipient, sponsored by Devyser Inc.. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Devyser Inc. · Observational

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

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

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03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 400 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Devyser Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Kidney Transplant Recipients

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

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Kidney transplant recipients

    Kidney transplant recipients who are 18 years of age or older

06

What researchers measure

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 months

07

Study locations

5 of 6 sites recruiting
  • 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
    Completed
08

References and documents

Publications

  • 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. PubMed 37951377 ↗

Individual participant data

Plan to share: No — We do not plan to share individual participant data with other researchers. Any shared data will be de-identified data at the cohort level in aggregate.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07006831
Lead sponsor
Devyser Inc.
Responsible party
Sponsor
First posted
Jun 5, 2025
Start date
Nov 14, 2025
Primary completion
Dec 2027 (estimated)
Completion
Mar 2028 (estimated)
Last update
Aug 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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