Kidney InjurySTAARTNCT05747053
Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
An observational study of Kidney Injury and Kidney Failure, run by George Washington University at 1 site in United States.
Trial summary
Long-term graft failure rates continue to be unacceptably high despite the development of immunosuppressive drugs, underscoring the unmet need for robust prognostic biomarkers of allograft injury and failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Injury, Kidney Failure, Kidney Failure, Chronic
- What is being tested?
- AlloSure and PAXGene
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 8 Dec 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects with kidney transplants
Who may be able to join
- Adult 18-80 year old
- Kidney transplant recipients (de novo or re-transplant, from living or deceased donor)
- BMI over 30
- Recipients with pre formed human leukocyte antigens (HLA) antibodies
- Recipients with donor specific antibodies
- Recipients who have undergone blood type incompatible transplantation (ABO incompatible)
- Recipients who have had prior kidney transplants.
Who cannot join
- Multi-Visceral transplant (simultaneous kidney pancreas, liver kidney, heart kidney)
- Contraindication to renal biopsy
- Refusing biopsy
- Kidney transplant recipient that is a monozygotic twin to the donor
- When more than two genomes may be present in the recipient plasma (more than recipient + donor): pregnancy, multiple-organ transplants from different donors (kidney after heart, kidney after liver transplant etc.), recipients of allogeneic blood or bone marrow transplant who have received cells with a genome different from the recipient (e.g. non-monozygotic twin)
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University
Washington D.C., District of Columbia, 20037
About this study
Official title: Surveillance Testing Utilizing AlloSure to Assess Rejection Following Transplantation and Personalization of Immunosuppressive Therapy
Long-term graft failure rates continue to be unacceptably high despite the development of immunosuppressive drugs, underscoring the unmet need for robust prognostic biomarkers of allograft injury and failure. While rates of acute rejection (AR) continue to decrease, it remains the strongest predictor of long-term allograft survival, and so having a better understanding of factors predicting AR may contribute to more individualized patient care. Selecting optimum immunosuppressive dosage is another factor in personalizing kidney care. This project will study two areas of individualized kidney care: 1) assessing rejection by surveillance testing utilizing AlloSure, 2) developing an algorithm to select optimum immunosuppressive medication dosage.
- Conditions
- Kidney Injury, Kidney Failure, Kidney Failure, Chronic, Kidney Failure, Acute, Kidney Diseases, Kidney Transplant Rejection
- Being tested
- AlloSure, PAXGene
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic, Acute Kidney Injury, Kidney Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlloSureDiagnostic test
AlloSure blood-draw at Post-operation day one and four, as well as one month, 2 months, 3, 9, 12, 15,18 and 24 months operation.
PAXGeneDiagnostic test
1 PAXgene tube will be collected with every biopsy performed and sent with the AlloSure test for the second 100 patients (patients 101-200). 21 gene markers will be sequenced by collecting 3 ml of blood.
| Study group | Role | What they receive |
|---|---|---|
| AlloSure Assay prediction of Anti-body Mediated Rejection | Determine whether AlloSure predicts the incidence of active, chronic Anti-body Mediated Rejection and cellular rejection in high risk patients Receives: Diagnostic Test: AlloSure; Diagnostic Test: PAXGene |
What is being measured
The primary outcome is the main question the study is designed to answer.
AlloSure value change
Examine if AlloSure predicts the incidence of active, chronic Active antibody mediated rejection (cAMR) and cellular rejection in high risk patients. This will be assessed through observing the changes in AlloSure values one draw after another.
Measured: post-operation day 1 and four. Pos-operation months 1, 2, 3,4,5,6
PAXGene,
The test will be used to develop an algorithm to personalize immunosuppressive medication intake.
Measured: 1 PAXgene tube will be collected 3 months post operation
PAXGene
The test will be used to develop an algorithm to personalize immunosuppressive medication intake.
Measured: 1 PAXgene tube will be collected one year post operation
Secondary outcomes (8)
Exploring the association between Cytochrome P450 (CYP) expression and Donor-Derived Cell-Free DNA (dd-cfDNA)
Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that AlloSure will correlate with increased CYP expression.
Measured: post-operation day 1
Exploring the association between CYP expression and dd-cfDNA
Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.
Measured: post-operation day 4
Exploring the association between CYP expression and dd-cfDNA
Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.
Measured: post-operation month 1
Exploring the association between CYP expression and dd-cfDNA
Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.
Measured: post-operation month 2
Exploring the association between CYP expression and dd-cfDNA
Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.
Measured: post-operation month 3
Exploring the association between CYP expression and dd-cfDNA
Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.
Measured: post-operation month 4
Exploring the association between CYP expression and dd-cfDNA
Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.
Measured: post-operation month 5
Exploring the association between CYP expression and dd-cfDNA
Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.
Measured: post-operation month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Oct 2020
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Why it stopped: will NOT resume
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney InjuryStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe 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
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- CareDx, VirginiaBio Analytics, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747053
- Sponsor's protocol ID
- NCR191914
- Acronym
- STAART
- Status last verified
- Feb 2024
- First submitted
- 27 Jan 2023
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance Testing Utilizing AlloSure to Assess Rejection Following Transplantation and Personalization of Immunosuppressive Therapy
- ClinicalTrials.gov ID
- NCT05747053
- Acronym / sponsor ID
- STAART / NCR191914
- Conditions
- Kidney Injury, Kidney Failure, Kidney Failure, Chronic, Kidney Failure, Acute, Kidney Diseases, Kidney Transplant Rejection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: will NOT resume
- Enrolment
- 105 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- CareDx, VirginiaBio Analytics, LLC
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 28 Feb 2023 (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.
Long-term graft failure rates continue to be unacceptably high despite the development of immunosuppressive drugs, underscoring the unmet need for robust prognostic biomarkers of allograft injury and failure. While rates of acute rejection (AR) continue to decrease, it remains the strongest predictor of long-term allograft survival, and so having a better understanding of factors predicting AR may contribute to more individualized patient care. Selecting optimum immunosuppressive dosage is another factor in personalizing kidney care. This project will study two areas of individualized kidney care: 1) assessing rejection by surveillance testing utilizing AlloSure, 2) developing an algorithm to select optimum immunosuppressive medication dosage.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AlloSure Assay prediction of Anti-body Mediated Rejection | – | Diagnostic Test: AlloSure, Diagnostic Test: PAXGeneDetermine whether AlloSure predicts the incidence of active, chronic Anti-body Mediated Rejection and cellular rejection in high risk patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects with kidney transplants
Key inclusion criteria (7 listed)
- Adult 18-80 year old
- Kidney transplant recipients (de novo or re-transplant, from living or deceased donor)
- BMI over 30
- Recipients with pre formed human leukocyte antigens (HLA) antibodies
- Recipients with donor specific antibodies
Key exclusion criteria (5 listed)
- Multi-Visceral transplant (simultaneous kidney pancreas, liver kidney, heart kidney)
- Contraindication to renal biopsy
- Refusing biopsy
- Kidney transplant recipient that is a monozygotic twin to the donor
- When more than two genomes may be present in the recipient plasma (more than recipient + donor): pregnancy, multiple-organ transplants from different donors (kidney after heart, kidney after liver transplant etc.), recipients of allogeneic blood or bone marrow transplant who have received cells with a genome different from the recipient (e.g. non-monozygotic twin)
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 blood-draw at Post-operation day one and four, as well as one month, 2 months, 3, 9, 12, 15,18 and 24 months operation. | Diagnostic test | AlloSure Assay prediction of Anti-body Mediated Rejection |
| PAXGene1 PAXgene tube will be collected with every biopsy performed and sent with the AlloSure test for the second 100 patients (patients 101-200). 21 gene markers will be sequenced by collecting 3 ml of blood. | Diagnostic test | AlloSure Assay prediction of Anti-body Mediated Rejection |
Primary outcome
AlloSure value change
Time frame: post-operation day 1 and four. Pos-operation months 1, 2, 3,4,5,6
Examine if AlloSure predicts the incidence of active, chronic Active antibody mediated rejection (cAMR) and cellular rejection in high risk patients. This will be assessed through observing the changes in AlloSure values one draw after another.
PAXGene,
Time frame: 1 PAXgene tube will be collected 3 months post operation
The test will be used to develop an algorithm to personalize immunosuppressive medication intake.
PAXGene
Time frame: 1 PAXgene tube will be collected one year post operation
The test will be used to develop an algorithm to personalize immunosuppressive medication intake.
8 secondary outcomes
Exploring the association between Cytochrome P450 (CYP) expression and Donor-Derived Cell-Free DNA (dd-cfDNA)
Time frame: post-operation day 1
Exploring the association between CYP expression and dd-cfDNA
Time frame: post-operation day 4
Exploring the association between CYP expression and dd-cfDNA
Time frame: post-operation month 1
Exploring the association between CYP expression and dd-cfDNA
Time frame: post-operation month 2
Exploring the association between CYP expression and dd-cfDNA
Time frame: post-operation month 3
Exploring the association between CYP expression and dd-cfDNA
Time frame: post-operation month 4
Exploring the association between CYP expression and dd-cfDNA
Time frame: post-operation month 5
Exploring the association between CYP expression and dd-cfDNA
Time frame: post-operation month 6
Results and safety
The study was stopped early (reason given: will NOT resume). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Kidney Injury and Kidney Failure, run by George Washington University 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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 26 Feb 2024. 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 was stopped early (reason given: will NOT resume). Results are not available in the source record.
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?
AlloSure value change (time frame: post-operation day 1 and four. Pos-operation months 1, 2, 3,4,5,6). The study lists 3 primary outcomes in all. 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 26 Feb 2024.