Kidney Transplant
Conditions
Keywords
kidney transplant, dd-cfDNA, cell-free DNA, allograft rejection, donor derived cell-free DNA, kidney rejection, rejection
Brief summary
The GALACTIC Registry study purpose is to validate the Combination Model-score (CM-score) for increased accuracy in the percentage of the positive predictive value (PPV) of allograft rejection results for the GraftAssure (GraftAssureCore and GraftAssureDx) assay. This will also be correlated with the biopsy yield and treatment decisions. The GraftAssure assay is a diagnostic test intended for the quantitative measurement of dd-cfDNA in plasma from kidney transplant recipients. The test is minimally invasive, and is intended to be used in conjunction with standard clinical assessment and other laboratory findings as an aid in the detection of allograft rejection.
Detailed description
This is a prospective, multi-center, longitudinal, registry study. The study will be conducted in two parts: Part 1: GraftAssureCore assay (Laboratory-Developed Test) Blood samples will be obtained by the site, or via contracted phlebotomy or laboratory services, and shipped to iMDx for centralized GraftAssure testing. Results will be reported to the study site. Part 2: GraftAssureDx assay (On-Site Testing at study site) Sites will be trained to perform on-site GraftAssure testing in-house with iMDx permission, post-FDA authorization.
Interventions
None listed
Sponsors
Insight Molecular Diagnostics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Prospective Participant 1. 18 years of age or older. 2. ≥ 2 weeks post-kidney transplant at the time of first sample collection. 3. Provides legally effective informed consent. 4. Agrees to comply with all study procedures. Inclusion Criteria: Historical Control Participant 1. 18 years of age or older 2. Has a minimum of three clinical evaluations per year post-transplant.
Exclusion criteria
Prospective Participant 1. Has received transplanted kidney from their identical twin. 2. Has a history of another previously transplanted organ in situ, other than a prior kidney transplant. 3. Has received an allogenic bone marrow graft or hematopoietic stem cell transplantation (HSCT). 4. Self-reports as pregnant. 5. Has a current malignancy, other than low-grade malignancy. 6. Actively enrolled in another cfDNA assay-based trial. 7. In the opinion of the investigator, participation in this study would pose a risk to data integrity or to the participant's safety and welfare.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detect Rejection | 7 years | Detection of rejection using fractional abundance (%) dd-cfDNA, absolute (cp/mL) dd-cfDNA, and a Combination Model-score of both of these values. |
| Validate Superiority of Combination Model-score (CM-score) | 7 years | Validate superiority of combined use of percent \& cp/mL dd-cfDNA values, defined as Combination Model-score, over individual dd-cfDNA percent and cp/mL values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association of dd-cfDNA levels | 7 years | Association of dd-cfDNA levels and graft survival/retained function, retransplant, DSA development, and patient survival. |
| Graft survival | 7 years | Graft survival |
| Biopsy rate and yield | 7 years | — |
| Time-to-intervention impact | 7 years | Lower hospitalization rates, less severe rejection, lower treatment intensity. |
Countries
United States
Contacts
CONTACTAnnum Zhara, MSc.
CONTACTHaley Russell
Outcome results
None listed