Kidney Transplant; ComplicationsNCT06463873
Study of OmniGraft in Simultaneous Pancreas Kidney Recipients
An observational study of Kidney Transplant; Complications and Pancreas Disease, run by University of Miami at 2 sites in United States.
Trial summary
The purpose of this research is learn about how OmniGraf works in kidney pancreas transplant patients. Also, to analyze the performance characteristics of OmniGrafTM (TruGraf Gene Expression Profiling (GEP) and T Cell Receptor Alpha Constant (TRAC) dd-cfDNA) in a population of simultaneous kidney pancreas transplants… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplant; Complications, Pancreas Disease
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2024to 11 Feb 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Simultaneous kidney pancreas transplant who are treated at the Miami Transplant Institute
Who may be able to join
- Male or female adult (≥18 years old) with a history of simultaneous pancreas kidney transplant between 3 months and 1 year prior to enrollment (cohort 1) or at the time of presentation for "for-cause" biopsy
- Adults able to consent
- Bladder or enteric drained
- Type 1 or Type 2 DM
Who cannot join
- Recipient of an organ transplant other than a simultaneous pancreas kidney transplant
- Known to be pregnant
- Known to be infected with Human Immunodeficiency Virus with actively replicating HIV virus
- Active BK viremia with >100,000 copies or biopsy proven BK nephropathy
- Participation in other biomarker studies
- Pancreas transplant alone
- Re-transplantation, unless both organs have been removed prior to or at the time of the retransplant procedure.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Miami Transplant Institute 1801 NW 9th Ave
Miami, Florida, 33136
University of Miami
Miami, Florida, 33136
About this study
Official title: A Pilot Study of OmniGraft in Simultaneous Pancreas Kidney Recipients
The purpose of this research is learn about how OmniGraf works in kidney pancreas transplant patients. Also, to analyze the performance characteristics of OmniGrafTM (TruGraf Gene Expression Profiling (GEP) and T Cell Receptor Alpha Constant (TRAC) dd-cfDNA) in a population of simultaneous kidney pancreas transplants as a part of routine surveillance, as well as a part of the workup for patients clinically suspected to have rejection of the kidney and/or pancreas.
- Conditions
- Kidney Transplant; Complications, Pancreas Disease
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Omnigraft 3 month - 1 year Group 1 | Subjects will be enrolled between 2 months and 1 year post Simultaneous Pancreas Kidney (SPK) transplant. Blood sample to test Omnigraft will be collected monthly month or every 3 months depending on the enrollment time, time of rejection, or when a biopsy is done. | |
| Omnigraft 1 year - 3 years Group 2 | Subjects will be enrolled between 12 months and 3 year post SPK transplant. Blood sample to test Omnigraft will be collected every 3 months, at the time of rejection or when a biopsy is done. | |
| Omnigraft 10 years Group 3 | Subjects will be enrolled between 3 years to 10 years post SPK transplant. Then, blood samples to test Omnigraft will be collected every 3 months, time of rejection or when a biopsy is done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that underwent SPK transplant
Number of participants that underwent SPK transplant measured by Omnigraft testing. The Omnigraft test includes TruGraf GEP and TRAC dd-cfDNA.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Jul 2024
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Why it stopped: The sponsor suspended the financial support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Eurofins Lancaster Laboratories
- Responsible party
- Principal investigator, Mariella Ortigosa Goggins, University of Miami
- Investigators
- Mariella Ortigosa-Goggins, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463873
- Sponsor's protocol ID
- 20221147
- Status last verified
- Oct 2024
- First submitted
- 10 Jun 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of OmniGraft in Simultaneous Pancreas Kidney Recipients
- ClinicalTrials.gov ID
- NCT06463873
- Acronym / sponsor ID
- 20221147
- Conditions
- Kidney Transplant; Complications, Pancreas Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The sponsor suspended the financial support.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Eurofins Lancaster Laboratories
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 18 Jun 2024 (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 purpose of this research is learn about how OmniGraf works in kidney pancreas transplant patients. Also, to analyze the performance characteristics of OmniGrafTM (TruGraf Gene Expression Profiling (GEP) and T Cell Receptor Alpha Constant (TRAC) dd-cfDNA) in a population of simultaneous kidney pancreas transplants as a part of routine surveillance, as well as a part of the workup for patients clinically suspected to have rejection of the kidney and/or pancreas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omnigraft 3 month - 1 year Group 1 | – | –Subjects will be enrolled between 2 months and 1 year post Simultaneous Pancreas Kidney (SPK) transplant. Blood sample to test Omnigraft will be collected monthly month or every 3 months depending on the enrollment time, time of rejection, or when a biopsy is done. |
| Omnigraft 1 year - 3 years Group 2 | – | –Subjects will be enrolled between 12 months and 3 year post SPK transplant. Blood sample to test Omnigraft will be collected every 3 months, at the time of rejection or when a biopsy is done. |
| Omnigraft 10 years Group 3 | – | –Subjects will be enrolled between 3 years to 10 years post SPK transplant. Then, blood samples to test Omnigraft will be collected every 3 months, time of rejection or when a biopsy is done. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Simultaneous kidney pancreas transplant who are treated at the Miami Transplant Institute
Key inclusion criteria (4 listed)
- Male or female adult (≥18 years old) with a history of simultaneous pancreas kidney transplant between 3 months and 1 year prior to enrollment (cohort 1) or at the time of presentation for "for-cause" biopsy
- Adults able to consent
- Bladder or enteric drained
- Type 1 or Type 2 DM
Key exclusion criteria (7 listed)
- Recipient of an organ transplant other than a simultaneous pancreas kidney transplant
- Known to be pregnant
- Known to be infected with Human Immunodeficiency Virus with actively replicating HIV virus
- Active BK viremia with >100,000 copies or biopsy proven BK nephropathy
- Participation in other biomarker studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants that underwent SPK transplant
Time frame: Up to 3 years
Number of participants that underwent SPK transplant measured by Omnigraft testing. The Omnigraft test includes TruGraf GEP and TRAC dd-cfDNA.
Results and safety
The study was stopped early (reason given: The sponsor suspended the financial support.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- 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.
Mariella Ortigosa-Goggins, MD principal investigator
University of Miami
2 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; Complications and Pancreas Disease, run by University of Miami at 2 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 7 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 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: The sponsor suspended the financial support.). 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?
Number of participants that underwent SPK transplant (time frame: Up to 3 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 27 Feb 2025.