Transition of Renal Patients Using AlloSure Into Community Kidney Care

Kidney Transplant Rejection Clinical Trial

— TRACK  

Official title:

Transition of Renal Patients Using AlloSure Into Community Kidney Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04601155
• Other study ID #: SN-C-00012
• Status: Completed
• 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
• 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).

Related Conditions & MeSH terms

• Kidney Transplant Rejection

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