Pancreas Transplant RejectionNCT04130685
Donor-Derived Cell-Free DNA for Surveillance in Simultaneous Pancreas and Kidney Transplant Recipients
An observational study of Pancreas Transplant Rejection and Kidney Transplant Rejection, run by Rush University Medical Center at 1 site in United States.
Trial summary
The AlloSure test is approved by the Centers for Medicare \& Medicaid Services (CMS) for use in Medicare patients to assess the probability of allograft rejection in kidney transplant patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Transplant Rejection, Kidney Transplant Rejection
- What is being tested?
- Allosure Test
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 1 Dec 2022
- How long will I take part?
- 3 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recipients of Simultaneous Pancreas and Kidney (SPK) transplant since 2012 and above the age of 18 will be enrolled.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- New SPK transplant recipients
- SPK recipients from September 2012 with functioning kidney and pancreas, not on dialysis and/or insulin
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- Unwilling to participate in research study
- Recipients of other solid organ transplants apart from the SPK
- Recipients of pancreas and kidney allografts from separate donors
- Recipients with SLE
- Patients who have received a bone marrow transplant
Show all 11Show fewer
- Recipients of a transplant form a monozygotic twin
- Patients who are pregnant
- Patients below the age of 18 years
- SPK recipient on insulin at enrolment
- SPK recipient on dialysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
The AlloSure test is approved by the Centers for Medicare \& Medicaid Services (CMS) for use in Medicare patients to assess the probability of allograft rejection in kidney transplant patients. The pivotal DART study discusses the use of the non-invasive AlloSure test to measure donor derived cell-free DNA (dd-cfDNA) and the Allosure test can by used to discriminate active rejection in renal transplant patients. Pancreas allograft rejection still remains a major clinical challenge and is a primary cause of death censored pancreas allograft loss. Pancreas transplant rejection is diagnosed by biopsy, however it is not commonly performed because of the complications such as pancreatic leak, graft loss and patient death. Currently at Rush surveillance biopsy of the pancreas are not performed routinely due to the above risks.
At RUMC, patients are followed post-transplant with series of labs at set intervals that include lipase, DSA, C-Peptide, and GAD65 for surveillance of rejection
Read more
The AlloSure test was introduced for routine use in kidney transplant recipients at Rush University Medical Center in October 2017, after CMS approval and then as part of the KOAR Study in May of 2018. AlloSure test has been included as part of the routine labs for surveillance of rejection in pancreas transplant recipients at RUMC since September 2018 after it was approved for compassionate use. The addition of AlloSure has helped to improve surveillance of rejection in pancreas transplant recipients and has reduced the need for the kidney biopsy as a surrogate marker of rejection in the pancreas.
Our goal is to determine if AlloSure can be used for surveillance for rejection in recipients of Simultaneous Pancreas and Kidney (SPK) Transplant recipients.
Read the detailed description
This is a prospective and retrospective cohort study of recipients of simultaneous pancreas and kidney transplant recipients (SPK).
New SPK transplant recipients and previous SPK transplant recipients from September 2012 will be enrolled in the study, expected duration of participation will therefore range from a minimum of 1 year to a maximum of 5 years for each participant.
The visits are incorporated into the current standard of care in our program and no extra visits are required. Mobile draw for AlloSure can be obtained if the patient is not due for a visit when the AlloSure draw is due.
AlloSure labs will be drawn on all new SPK patients and results obtained as well as retrospective results that have already been received on past SPK recipients. The AlloSure will be added to the standard of care schedule for all SPK patients.
The schedule will be the following:
For newly transplanted patients, AlloSure will be checked at 14 days post-transplant
For all subjects:
From 1 month to 12 months post transplant: AlloSure will be obtained monthly with their transplant date as the reference time point
From 12 months to 36 months: AlloSure will be obtained every 3 months
From 36 months to 60 months: AlloSure will be obtained every 6 months.
AlloSure may be obtained more frequently than the above schedule, with other clinical data or allograft biopsy, if there is graft dysfunction or suspicion for rejection.
- Being tested
- Allosure Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allosure TestDiagnostic test
Venous Blood Draw
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine median AlloSure level in SPK recipients with stable allograft function
Percentage of dd-cfDNA (AlloSure) level in blood samples of recipients of kidney and pancreas transplant.
Measured: Median allosure level collected from two weeks post transplant up until 36 months post transplant.
Secondary outcomes (2)
The Allosure levels will be measured in the setting of rejection.
Determine AlloSure levels at time of rejection
Measured: Throughout study completion, which is three years from date of transplant.
To determine the Allosure level post transplant
AlloSure level
Measured: Throughout study completion, which is three years from date of transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start15 Jan 2020
- Primary completion31 May 2021
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 48 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- CareDx
- Responsible party
- Sponsor
- Investigators
- Oyedolamu Olaitan, MBBS, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130685
- Sponsor's protocol ID
- 19073007
- Status last verified
- Dec 2022
- First submitted
- 7 Oct 2019
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donor-Derived Cell-Free DNA for Surveillance in Simultaneous Pancreas and Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT04130685
- Acronym / sponsor ID
- 19073007
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- CareDx
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 17 Oct 2019 (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.
The AlloSure test is approved by the Centers for Medicare \& Medicaid Services (CMS) for use in Medicare patients to assess the probability of allograft rejection in kidney transplant patients. The pivotal DART study discusses the use of the non-invasive AlloSure test to measure donor derived cell-free DNA (dd-cfDNA) and the Allosure test can by used to discriminate active rejection in renal transplant patients. Pancreas allograft rejection still remains a major clinical challenge and is a primary cause of death censored pancreas allograft loss. Pancreas transplant rejection is diagnosed by biopsy, however it is not commonly performed because of the complications such as pancreatic leak, graft loss and patient death. Currently at Rush surveillance biopsy of the pancreas are not performed routinely due to the above risks.
At RUMC, patients are followed post-transplant with series of labs at set intervals that include lipase, DSA, C-Peptide, and GAD65 for surveillance of rejection
The AlloSure test was introduced for routine use in kidney transplant recipients at Rush University Medical Center in October 2017, after CMS approval and then as part of the KOAR Study in May of 2018. AlloSure test has been included as part of the routine labs for surveillance of rejection in pancreas transplant recipients at RUMC since September 2018 after it was approved for compassionate use. The addition of AlloSure has helped to improve surveillance of rejection in pancreas transplant recipients and has reduced the need for the kidney biopsy as a surrogate marker of rejection in the pancreas.
Our goal is to determine if AlloSure can be used for surveillance for rejection in recipients of Simultaneous Pancreas and Kidney (SPK) Transplant recipients.
Detailed description
This is a prospective and retrospective cohort study of recipients of simultaneous pancreas and kidney transplant recipients (SPK).
New SPK transplant recipients and previous SPK transplant recipients from September 2012 will be enrolled in the study, expected duration of participation will therefore range from a minimum of 1 year to a maximum of 5 years for each participant.
The visits are incorporated into the current standard of care in our program and no extra visits are required. Mobile draw for AlloSure can be obtained if the patient is not due for a visit when the AlloSure draw is due.
AlloSure labs will be drawn on all new SPK patients and results obtained as well as retrospective results that have already been received on past SPK recipients. The AlloSure will be added to the standard of care schedule for all SPK patients.
The schedule will be the following:
For newly transplanted patients, AlloSure will be checked at 14 days post-transplant
For all subjects:
From 1 month to 12 months post transplant: AlloSure will be obtained monthly with their transplant date as the reference time point
From 12 months to 36 months: AlloSure will be obtained every 3 months
From 36 months to 60 months: AlloSure will be obtained every 6 months.
AlloSure may be obtained more frequently than the above schedule, with other clinical data or allograft biopsy, if there is graft dysfunction or suspicion for rejection.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recipients of Simultaneous Pancreas and Kidney (SPK) transplant since 2012 and above the age of 18 will be enrolled.
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- New SPK transplant recipients
- SPK recipients from September 2012 with functioning kidney and pancreas, not on dialysis and/or insulin
Key exclusion criteria (11 listed)
- Unwilling to participate in research study
- Recipients of other solid organ transplants apart from the SPK
- Recipients of pancreas and kidney allografts from separate donors
- Recipients with SLE
- Patients who have received a bone marrow 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 |
|---|---|---|
| Allosure TestVenous Blood Draw | Diagnostic test | – |
Primary outcome
To determine median AlloSure level in SPK recipients with stable allograft function
Time frame: Median allosure level collected from two weeks post transplant up until 36 months post transplant.
Percentage of dd-cfDNA (AlloSure) level in blood samples of recipients of kidney and pancreas transplant.
2 secondary outcomes
The Allosure levels will be measured in the setting of rejection.
Time frame: Throughout study completion, which is three years from date of transplant.
To determine the Allosure level post transplant
Time frame: Throughout study completion, which is three years from date of transplant.
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 2 Dec 2022.
- Cell-Free DNA and Active Rejection in Kidney Allografts.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Pancreas Transplant Rejection
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A Multicenter Randomized Controlled Trial to Treat Acute T Cell Mediated Rejection in Kidney and Kidney-Pancreas Transplant Recipients
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A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients
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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.
Oyedolamu Olaitan, MBBS principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Transplant Rejection and Kidney Transplant Rejection, run by Rush University Medical Center at 1 site 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 11 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 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To determine median AlloSure level in SPK recipients with stable allograft function (time frame: Median allosure level collected from two weeks post transplant up until 36 months post transplant.). 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 2 Dec 2022.