Transition of Renal Patients Using AlloSure Into Community Kidney Care

Part of paid clinical trials in Fairfield, California.

Sponsor
CareDx
Study ID
NCT04601155
Status
Completed

Conditions

  • Kidney Transplant Rejection

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AlloSure — DEVICE
    AlloSure is an analytically validated targeted next-generation sequencing (NGS) assay that uses single-nucleotide polymorphisms (SNPs) to measure the fraction of dd-cfDNA in transplant patients without the need for genotyping either the donor or the recipient.8

Study Details

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 Dates

First listed
Oct 23, 2020
Start date
Nov 19, 2020
Status verified
Nov 2023
Primary completion
Mar 24, 2023
Completion
Oct 6, 2023

Study Design

Enrollment
248 participants (actual)

Arms

  • Arm: AlloSure Group
    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. For the quarterly AlloSure tests, approximately 20 mL of blood will be obtained in Streck Cell-Free DNA BCT tubes and shipped to CareDx, Inc. (Brisbane, CA) to analyze the presence of donor-derived cell-free DNA.
  • Arm: Control Group
    The control group was never followed with AlloSure as part of their post-transplant follow-up care. Matched control data will originate from UNOS SRTR data.

Primary Outcome Measure

Superior allograft survival [ Time Frame: 5 years ]

Locations (18)

FacilityCityStateZIPSite coordinators
Amicis Research CenterFairfieldCalifornia94533-
The Medical Research Group - FresnoFresnoCalifornia93720-
Amicis Research CenterGranada HillsCalifornia91344-
Amicis Research CenterMission HillsCalifornia91345-
California Institute of Renal Research (Balboa)San DiegoCalifornia92123-
Starling PhysiciansHartfordConnecticut06106-
George Washington/Medical Faculty Associates Inc.Washington D.C.District of Columbia20037-
Physician Consultants of GeorgiaMaconGeorgia31201-
NANI ResearchHinsdaleIllinois60521-
NANI ResearchFort WayneIndiana46804-
Washington UniversitySt LouisMissouri63110-
PRINE HealthManhassetNew York11030-
Chinatown KidneyNew YorkNew York10013-
Nephrology Associates PC, QueensQueensNew York11355-
Sholer Chris MDOklahoma CityOklahoma73116-
Utah Kidney Research InstituteSouth OgdenUtah84403-
Lynchburg Nephrology Physicians, PLLCLynchburgVirginia24501-
Mendez Center for Clinical ResearchWoodbridgeVirginia22192-

Find similar trials in Fairfield, CA

By research site
Amicis Research Center· Fairfield, CAThe Medical Research Group - Fresno· Fresno, CAAmicis Research Center· Granada Hills, CAAmicis Research Center· Mission Hills, CACalifornia Institute of Renal Research (Balboa)· San Diego, CAStarling Physicians· Hartford, CT

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