TRACK: Transition of Renal Patients Using AlloSure Into Community Kidney Care

Sponsor
CareDx (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04601155
Collaborator
(none)
3,500
17
69.7
205.9
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: AlloSure

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
3500 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Transition of Renal Patients Using AlloSure Into Community Kidney Care
Actual Study Start Date :
Nov 19, 2020
Anticipated Primary Completion Date :
Sep 10, 2026
Anticipated Study Completion Date :
Sep 10, 2026

Arms and Interventions

Arm Intervention/Treatment
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
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

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.

Outcome Measures

Primary Outcome Measures

  1. Superior allograft survival [5 years]

    Time to allograft loss, defined as composite of: return to dialysis, re-transplant, death due to allograft failure, and death with functioning allograft.

Secondary Outcome Measures

  1. Assessment of kidney function [5 years]

    Relative change in eGFR from baseline in groups monitored using AlloSure compared to matched control group.

  2. Assessment of immunologic status [5 years]

    Proportion of patients with formation of de-novo DSA antibodies in groups monitored using AlloSure compared to matched control group.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Amicis Research Center Fairfield California United States 94533
2 The Medical Research Group - Fresno Fresno California United States 93720
3 Amicis Research Center Granada Hills California United States 91344
4 Amicis Research Center Mission Hills California United States 91345
5 California Institute of Renal Research (Balboa) San Diego California United States 92123
6 Starling Physicians Hartford Connecticut United States 06106
7 George Washington/Medical Faculty Associates Inc. Washington District of Columbia United States 20037
8 Physician Consultants of Georgia Macon Georgia United States 31201
9 NANI Research Hinsdale Illinois United States 60521
10 NANI Research Fort Wayne Indiana United States 46804
11 PRINE Health Manhasset New York United States 11030
12 Nephrology Associates PC, Queens Queens New York United States 11355
13 Sholer Chris MD Oklahoma City Oklahoma United States 73116
14 Carolina Nephrology, PA Greer South Carolina United States 29650
15 Utah Kidney Research Institute South Ogden Utah United States 84403
16 Lynchburg Nephrology Physicians, PLLC Lynchburg Virginia United States 24501
17 Mendez Center for Clinical Research Woodbridge Virginia United States 22192

Sponsors and Collaborators

  • CareDx

Investigators

  • Study Director: Sham Dholakia, CareDx

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CareDx
ClinicalTrials.gov Identifier:
NCT04601155
Other Study ID Numbers:
  • SN-C-00012
First Posted:
Oct 23, 2020
Last Update Posted:
Dec 1, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes

Study Results

No Results Posted as of Dec 1, 2021