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

a study on Kidney Disease Kidney Transplant Transplants Transplant Recipient Renal Function Cell-free DNA NGS

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Amarpali Brar, MD

Description

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.

Details

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.

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

  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).

You CAN'T join if...

  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)

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • Scripps Health accepting new patients
    San Diego California 92037 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Devyser Inc.
ID
NCT07006831
Study Type
Observational
Participants
Expecting 400 study participants
Last Updated
Contact us about this trial