Rejection of Kidney AllograftOmnigrafNCT05477082
Blood Biomarkers in Pediatric Kidney Transplant Recipients
An observational study of Rejection of Kidney Allograft, run by University of Minnesota at 1 site in United States.
Trial summary
The objective of the proposed study is to assess whether a blood biomarker can be used to monitor the response to rejection treatment in pediatric kidney transplant recipients with biopsy-proven acute cellular or antibody mediated rejection. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Rejection of Kidney Allograft
- What is being tested?
- Observational group
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2023to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric kidney transplant recipients, ages < 21 years, scheduled to undergo a for-cause kidney biopsy to rule out graft rejection
Who may be able to join
- Kidney transplant recipients
- Participants undergoing a for-cause kidney biopsy to rule out graft rejection
- Ages 21 years and less
Who cannot join
- Participants who have opted out of research
- Patients, less than 18 years of age, whose parents or legal guardians are illiterate and cannot read.
- Participants, 18 years and older, who are illiterate and cannot read.
- Participants, less than 18 years of age, whose parents or legal guardians do not speak English.
- Participants, 18 years and older, who do not speak English
- Participants who are pregnant as confirmed by medical records
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Use of Blood Gene Expression Profile and Donor-derived Cell-free DNA to Monitor Response to Treatment After Biopsy-proven Acute Rejection in Pediatric Kidney Transplant Recipients
The objective of the proposed study is to assess whether a blood biomarker can be used to monitor the response to rejection treatment in pediatric kidney transplant recipients with biopsy-proven acute cellular or antibody mediated rejection. The study hypothesizes that blood gene expression profile and donor-derived cell-free DNA biomarkers (omnigraf) can be used to predict acute rejection and monitor its response to treatment.
- Conditions
- Rejection of Kidney Allograft
- Being tested
- Observational group
- Keywords
- acute rejection, kidney transplant, pediatric, biomarker, cell free DNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational groupOther
Includes blood draws and data collection only
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy-proven acute rejection
Yes or No assessment
Measured: 7 days from baseline
Clinical resolution of rejection
Yes or No assessment; defined as improvement in serum creatinine to a value that is within 25% of baseline serum creatinine
Measured: 8 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start21 Aug 2023
- Primary completion16 Nov 2025
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rejection of Kidney AllograftStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Kizilbash, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477082
- Sponsor's protocol ID
- PEDS-2022-30750
- Acronym
- Omnigraf
- Status last verified
- Nov 2026
- First submitted
- 25 Jul 2022
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Blood Gene Expression Profile and Donor-derived Cell-free DNA to Monitor Response to Treatment After Biopsy-proven Acute Rejection in Pediatric Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT05477082
- Acronym / sponsor ID
- Omnigraf / PEDS-2022-30750
- Conditions
- Rejection of Kidney Allograft
- Keywords
- acute rejection, kidney transplant, pediatric, biomarker, cell free DNA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 16 Nov 2025 (actual)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 28 Jul 2022 (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 objective of the proposed study is to assess whether a blood biomarker can be used to monitor the response to rejection treatment in pediatric kidney transplant recipients with biopsy-proven acute cellular or antibody mediated rejection. The study hypothesizes that blood gene expression profile and donor-derived cell-free DNA biomarkers (omnigraf) can be used to predict acute rejection and monitor its response to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric kidney transplant recipients, ages < 21 years, scheduled to undergo a for-cause kidney biopsy to rule out graft rejection
Key inclusion criteria (3 listed)
- Kidney transplant recipients
- Participants undergoing a for-cause kidney biopsy to rule out graft rejection
- Ages 21 years and less
Key exclusion criteria (6 listed)
- Participants who have opted out of research
- Patients, less than 18 years of age, whose parents or legal guardians are illiterate and cannot read.
- Participants, 18 years and older, who are illiterate and cannot read.
- Participants, less than 18 years of age, whose parents or legal guardians do not speak English.
- Participants, 18 years and older, who do not speak English
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 |
|---|---|---|
| Observational groupIncludes blood draws and data collection only | Other | – |
Primary outcome
Biopsy-proven acute rejection
Time frame: 7 days from baseline
Yes or No assessment
Clinical resolution of rejection
Time frame: 8 weeks from baseline
Yes or No assessment; defined as improvement in serum creatinine to a value that is within 25% of baseline serum creatinine
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Related trials for Rejection of Kidney Allograft
Active, not recruitingObservational study
Australian Genomics Of Chronic Allograft Dysfunction Study
Kidney Transplant Rejection, Kidney Transplant; Complications
Not yet recruitingPhase 3
Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation
Kidney Transplant Rejection
Active, not recruitingObservational study
Extended Validation of Donor-derived Cell-free DNA in Kidney Transplant Recipients
Rejection Acute Renal, Rejection Chronic Renal
RecruitingPhase 2
VEL-101 to Prevent Rejection After Kidney Transplantation
Transplantation, Kidney
RecruitingPhase 3
A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications
Renal Allograft Recipients
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.
Sarah Kizilbash, MD principal investigator
University of Minnesota
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 Rejection of Kidney Allograft, run by University of Minnesota 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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Biopsy-proven acute rejection (time frame: 7 days from baseline). The study lists 2 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 3 Nov 2026.