Correlation of Molecular Biomarkers With Biopsy Findings and Outcomes in Renal Transplant Recipients
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 82 |
| Updated: | 4/2/2016 |
| Start Date: | April 2015 |
| End Date: | December 2016 |
| Contact: | Angelo DeMattos, MD |
| Email: | angelo.demattos@ucdmc.ucdavis.edu |
| Phone: | 916-734-8620 |
This is a single-center, prospective, non-randomized, observational study to evaluate
specific proteogenomic biomarker panels for acute rejection (AR) and chronic allograft
nephropathy/interstitial fibrosis and tubular atrophy (CAN/IFTA) in blood, urine and kidney
tissue (biopsy) in kidney transplant recipients. Proteogenomic profiles will be routinely
monitored over one year after enrollment.
specific proteogenomic biomarker panels for acute rejection (AR) and chronic allograft
nephropathy/interstitial fibrosis and tubular atrophy (CAN/IFTA) in blood, urine and kidney
tissue (biopsy) in kidney transplant recipients. Proteogenomic profiles will be routinely
monitored over one year after enrollment.
OBJECTIVE: The objective of this phase of the study is to allow the clinical site to gain
familiarity with patient recruitment, sample and data collection, and interpretation of the
proteogenomic biomarker report provided, through retrospective analysis. This phase of the
study will provide a platform for the transplant physicians to gain confidence with the
format, logistics, and potential use of the biomarker tests on blood and tissue.
familiarity with patient recruitment, sample and data collection, and interpretation of the
proteogenomic biomarker report provided, through retrospective analysis. This phase of the
study will provide a platform for the transplant physicians to gain confidence with the
format, logistics, and potential use of the biomarker tests on blood and tissue.
Inclusion Criteria: Patients who meet all of the following criteria are eligible for
enrollment as study participants:
1. Male and female recipients of all races, ≥18 years of age.
2. Patients undergoing primary or subsequent deceased-donor or living donor kidney
transplantation.
3. Subject and/or guardian must be able to provide informed consent.
4. Subject and/or guardian must be able to comply with the study protocol.
Exclusion Criteria:
1. Need for combined organ transplantation with an extra-renal organ and/or islet cell
transplant.
2. Recipients of previous non-renal solid organ and/or islet cell transplantation
3. Infection with HIV.
4. Inability or unwillingness of a participant and/or guardian to provide informed
consent
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