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The sponsor suspended the financial support.
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| Name | Class |
|---|---|
| Eurofins Lancaster Laboratories | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Simultaneous kidney pancreas transplant who are treated at the Miami Transplant Institute
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| Name | Affiliation | Role |
|---|---|---|
| Mariella Ortigosa-Goggins, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Transplant Institute 1801 NW 9th Ave | Miami | Florida | 33136 | United States | ||
| University of Miami |
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| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| Miami |
| Florida |
| 33136 |
| United States |