Clinical trial NCT04601155: Transition of Renal Patients Using AlloSure Into Community Kidney Care
Official title: Transition of Renal Patients Using AlloSure Into Community Kidney Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant Rejection
Lead sponsor: CareDx
Sponsor class: INDUSTRY
First posted: 2020-10-23
Enrollment: 248
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant patients who are having their transplant follow-up care in community nephrology

Brief summary: Patients undergoing kidney transplantation alone (either de-novo or re-transplant) at a participating hospital are routinely surveyed with interval blood tests as part of standard post-operative care through outpatient consultation. These tests include serum creatinine, blood sugar as well as DSA testing at various intervals. The ability to screen patients to better identify those who may be at risk of developing an adverse event using AlloSure cfDNA is likely to be advantageous, with the potential to improve graft survival and outcomes for transplant patients. The addition of AlloSure to the interventional group will be the focus of this study. Patients will have quarterly AlloSure cfDNA testing (every 3 months) and DSA as part of their post-transplant surveillance for a period of 5 years.Participants will attend outpatient visits/follow-up visits as part of their standard care, these will include appointments where they will have blood tests taken as part of post-transplant surveillance. For AlloSure cfDNA and DSA, blood will be taken quarterly.


Eligibility criteria: Inclusion Criteria:

* Participants with single kidney transplant (de-novo or re-transplant) who are ≥ 6 months and ≤ 36 months post-transplant. Participants and will need to have a draw in this time period .
* Participant is willing and able to give informed consent for participation in the trial.
* Male or Female, aged 12 years or older.
* In the Investigator's opinion, is able and willing to comply with all trial requirements.

Exclusion Criteria:

* Participant who is pregnant, lactating or planning pregnancy during the trial.
* Significant hepatic impairment (determined by the PI).
* Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
* Participant with life expectancy of less than 6 months, or inappropriate for diagnostic monitoring through regular blood sampling.
* \< 6 months and \> 36 months post-transplant
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
* Multi-organ transplant (e.g., Kidney-Pancreas).

Primary outcomes:
measure: Superior allograft survival
timeFrame: 5 years
Secondary outcomes:
measure: Assessment of kidney function
timeFrame: 5 years
measure: Assessment of immunologic status
timeFrame: 5 years
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Amicis Research Center
state: California
city: Fresno
country: United States
facility: The Medical Research Group - Fresno
state: California
city: Granada Hills
country: United States
facility: Amicis Research Center
state: California
city: Mission Hills
country: United States
facility: Amicis Research Center
state: California
city: San Diego
country: United States
facility: California Institute of Renal Research (Balboa)
state: California
city: Hartford
country: United States
facility: Starling Physicians
state: Connecticut
city: Washington
country: United States
facility: George Washington/Medical Faculty Associates Inc.
state: District of Columbia
city: Macon
country: United States
facility: Physician Consultants of Georgia
state: Georgia
city: Hinsdale
country: United States
facility: NANI Research
state: Illinois
city: Fort Wayne
country: United States
facility: NANI Research
state: Indiana
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Manhasset
country: United States
facility: PRINE Health
state: New York
city: New York
country: United States
facility: Chinatown Kidney
state: New York
city: Queens
country: United States
facility: Nephrology Associates PC, Queens
state: New York
city: Oklahoma City
country: United States
facility: Sholer Chris MD
state: Oklahoma
city: South Ogden
country: United States
facility: Utah Kidney Research Institute
state: Utah
city: Lynchburg
country: United States
facility: Lynchburg Nephrology Physicians, PLLC
state: Virginia
city: Woodbridge
country: United States
facility: Mendez Center for Clinical Research
state: Virginia
Study officials:
References: