Transition of Renal Patients Using AlloSure Into Community Kidney Care

NCT04601155 | Completed FDA Device

• 1 other identifier: SN-C-00012
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 18

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.

Conditions

Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Assessment of kidney function

  5 years

• Assessment of immunologic status

  5 years

Study Arms (2)

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.

Device: AlloSure

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.

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

AlloSure Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant patients who are having their transplant follow-up care in community nephrology

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).

Sponsors & Collaborators

• CareDx: lead

Study Sites (18)

Amicis Research Center

Fairfield, California, 94533, United States

Location

The Medical Research Group - Fresno

Fresno, California, 93720, United States

Location

Amicis Research Center

Granada Hills, California, 91344, United States

Location

Amicis Research Center

Mission Hills, California, 91345, United States

Location

California Institute of Renal Research (Balboa)

San Diego, California, 92123, United States

Location

Starling Physicians

Hartford, Connecticut, 06106, United States

Location

George Washington/Medical Faculty Associates Inc.

Washington D.C., District of Columbia, 20037, United States

Location

Physician Consultants of Georgia

Macon, Georgia, 31201, United States

Location

NANI Research

Hinsdale, Illinois, 60521, United States

Location

NANI Research

Fort Wayne, Indiana, 46804, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

PRINE Health

Manhasset, New York, 11030, United States

Location

Chinatown Kidney

New York, New York, 10013, United States

Location

Nephrology Associates PC, Queens

Queens, New York, 11355, United States

Location

Sholer Chris MD

Oklahoma City, Oklahoma, 73116, United States

Location

Utah Kidney Research Institute

South Ogden, Utah, 84403, United States

Location

Lynchburg Nephrology Physicians, PLLC

Lynchburg, Virginia, 24501, United States

Location

Mendez Center for Clinical Research

Woodbridge, Virginia, 22192, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

AlloSure Kidney is a blood test that analyzes SNPs selected across all 22 somatic chromosomes to detect DNA released from a patient's kidney allograft, known as donor-derived cell-free DNA (dd-cfDNA).

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: October 23, 2020
• Study Start: November 19, 2020
• Primary Completion: March 24, 2023
• Study Completion: October 6, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)