Transition of Renal Patients Using AlloSure Into Community Kidney Care

Completed

Conditions studied: Kidney Transplant Rejection

In brief

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.

Key facts

Study ID

NCT04601155

Run by

CareDx

People needed

248

Starts

2020-11-19

Expected to finish

2023-10-06

Last updated by the study team

2023-11-03

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Amicis Research Center — Fairfield, California, United States
• The Medical Research Group - Fresno — Fresno, California, United States
• Amicis Research Center — Granada Hills, California, United States
• Amicis Research Center — Mission Hills, California, United States
• California Institute of Renal Research (Balboa) — San Diego, California, United States
• Starling Physicians — Hartford, Connecticut, United States
• George Washington/Medical Faculty Associates Inc. — Washington D.C., District of Columbia, United States
• Physician Consultants of Georgia — Macon, Georgia, United States
• NANI Research — Hinsdale, Illinois, United States
• NANI Research — Fort Wayne, Indiana, United States
• Washington University — St Louis, Missouri, United States
• PRINE Health — Manhasset, New York, United States
• Chinatown Kidney — New York, New York, United States
• Nephrology Associates PC, Queens — Queens, New York, United States
• Sholer Chris MD — Oklahoma City, Oklahoma, United States
• Utah Kidney Research Institute — South Ogden, Utah, United States
• Lynchburg Nephrology Physicians, PLLC — Lynchburg, Virginia, United States
• Mendez Center for Clinical Research — Woodbridge, Virginia, United States

Full record on ClinicalTrials.gov

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