A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population
Purpose
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
- Kidney Transplant
- Transplant Recipient
- Renal Function
- Cell-free DNA
- NGS
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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)
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Kidney transplant recipients | Kidney transplant recipients who are 18 years of age or older |
Recruiting Locations
Scripps Health
San Diego, California 92037
San Diego, California 92037
University of California San Francisco
San Francisco, California 94143
San Francisco, California 94143
Piedmont Healthcare
Atlanta, Georgia 30309
Atlanta, Georgia 30309
University of Maryland Baltimore
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Brigham & Women's Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
University of Utah
Salt Lake City, Utah 84132
Salt Lake City, Utah 84132
More Details
- NCT ID
- NCT07006831
- Status
- Recruiting
- Sponsor
- Devyser Inc.
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.