Graft RejectionNCT05072951
Urine Biomarker for Kidney Transplant Rejection
An observational study of Graft Rejection, run by Exosome Diagnostics, Inc..
Trial summary
An adaptive sample collection to support biomarker evaluation for kidney transplant rejection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Rejection
- What is being tested?
- Urine Biomarker for Kidney Transplant Rejection
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Oct 2025
- 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
- Adult, Older adult
Study population: Male and Female, at least 18 years of age with a kidney transplant prior to enrollment.
Who may be able to join
- Ability to provide informed consent
- Kidney Transplant
Who cannot join
- Pediatric patients, under 18 years of age
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Adaptive Sample Collection to Evaluate a Biomarker for Kidney Transplant Rejection
An adaptive sample collection to support biomarker evaluation for kidney transplant rejection.
- Conditions
- Graft Rejection
- Being tested
- Urine Biomarker for Kidney Transplant Rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine Biomarker for Kidney Transplant RejectionDiagnostic test
Biomarker for active kidney transplant rejection.
What is being measured
The primary outcome is the main question the study is designed to answer.
Biospecimen collection
Measured: 3 years after last enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exosome Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sonia Kumar, Study chair, Exosome Diagnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072951
- Sponsor's protocol ID
- ECT2021-002
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2021
- Last updated
- 11 Oct 2021
- 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 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Sample Collection to Evaluate a Biomarker for Kidney Transplant Rejection
- ClinicalTrials.gov ID
- NCT05072951
- Acronym / sponsor ID
- ECT2021-002
- Conditions
- Graft Rejection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Exosome Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 11 Oct 2021 (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.
An adaptive sample collection to support biomarker evaluation for kidney transplant rejection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Male and Female, at least 18 years of age with a kidney transplant prior to enrollment.
Key inclusion criteria (2 listed)
- Ability to provide informed consent
- Kidney Transplant
Key exclusion criteria (1 listed)
- Pediatric patients, under 18 years of age
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 |
|---|---|---|
| Urine Biomarker for Kidney Transplant RejectionBiomarker for active kidney transplant rejection. | Diagnostic test | – |
Primary outcome
Biospecimen collection
Time frame: 3 years after last enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Graft Rejection
RecruitingObservational study
Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
Graft-versus-leukemia, Graft vs Host Disease
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
RecruitingPhase 1
A Study of LBP-MARCO and Ruxolitinib in People With Graft-Versus-Host Disease (GVHD)
Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)
Enrolling by invitationPhase 3
A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE)
Antibody-mediated Rejection, Microvascular Inflammation
Not yet recruiting
Molecular Evidence of Rejection Intervention Trial
Heart Transplant Rejection
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.
Sonia Kumar study chair
Exosome Diagnostics, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft Rejection, run by Exosome Diagnostics, Inc..
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonia Kumar, PhD (7816939600, Sonia.Kumar@bio-techne.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biospecimen collection (time frame: 3 years after last enrollment). 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 11 Oct 2021.