Kidney Transplant RejectionTRACKNCT04601155
Transition of Renal Patients Using AlloSure Into Community Kidney Care
An observational study of Kidney Transplant Rejection, run by CareDx at 18 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- AlloSure
- Type of treatment
- Medical device
- How many people
- 248 participants
- Where
- 18 sitesUnited States
- Study dates
- 19 Nov 2020to 6 Oct 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Kidney transplant patients who are having their transplant follow-up care in community nephrology
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Amicis Research Center
Fairfield, California, 94533
NANI Research
Fort Wayne, Indiana, 46804
The Medical Research Group - Fresno
Fresno, California, 93720
Amicis Research Center
Granada Hills, California, 91344
Starling Physicians
Hartford, Connecticut, 06106
NANI Research
Hinsdale, Illinois, 60521
Lynchburg Nephrology Physicians, PLLC
Lynchburg, Virginia, 24501
Physician Consultants of Georgia
Macon, Georgia, 31201
PRINE Health
Manhasset, New York, 11030
Amicis Research Center
Mission Hills, California, 91345
Chinatown Kidney
New York, New York, 10013
Sholer Chris MD
Oklahoma City, Oklahoma, 73116
Nephrology Associates PC, Queens
Queens, New York, 11355
California Institute of Renal Research (Balboa)
San Diego, California, 92123
Utah Kidney Research Institute
South Ogden, Utah, 84403
Washington University
St Louis, Missouri, 63110
George Washington/Medical Faculty Associates Inc.
Washington D.C., District of Columbia, 20037
Mendez Center for Clinical Research
Woodbridge, Virginia, 22192
About this study
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
- Being tested
- AlloSure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlloSureDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (2)
Assessment of kidney function
Relative change in eGFR from baseline in groups monitored using AlloSure compared to matched control group.
Measured: 5 years
Assessment of immunologic status
Proportion of patients with formation of de-novo DSA antibodies in groups monitored using AlloSure compared to matched control group.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start19 Nov 2020
- Primary completion24 Mar 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 248 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- CareDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601155
- Sponsor's protocol ID
- SN-C-00012
- Acronym
- TRACK
- Status last verified
- Nov 2023
- First submitted
- 10 Sep 2020
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition of Renal Patients Using AlloSure Into Community Kidney Care
- ClinicalTrials.gov ID
- NCT04601155
- Acronym / sponsor ID
- TRACK / SN-C-00012
- Conditions
- Kidney Transplant Rejection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- CareDxIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AlloSure Group | – | Device: AlloSurePatients 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. |
| 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Kidney transplant patients who are having their transplant follow-up care in community nephrology
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlloSureAlloSure 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 | Device | AlloSure Group |
Primary outcome
Superior allograft survival
Time frame: 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.
2 secondary outcomes
Assessment of kidney function
Time frame: 5 years
Assessment of immunologic status
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Rejection, run by CareDx at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superior allograft survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.