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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04601155
Other study ID # SN-C-00012
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 19, 2020
Est. completion date October 6, 2023

Study information

Verified date November 2023
Source CareDx
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 248
Est. completion date October 6, 2023
Est. primary completion date March 24, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AlloSure
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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
CareDx

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Superior allograft survival Time to allograft loss, defined as composite of: return to dialysis, re-transplant, death due to allograft failure, and death with functioning allograft. 5 years
Secondary Assessment of kidney function Relative change in eGFR from baseline in groups monitored using AlloSure compared to matched control group. 5 years
Secondary Assessment of immunologic status Proportion of patients with formation of de-novo DSA antibodies in groups monitored using AlloSure compared to matched control group. 5 years
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