Clinical trial NCT02463253: Correlation of Molecular Biomarkers With Biopsy Findings and Outcomes in Renal Transplant Recipients
Official title: Correlation of Molecular Biomarkers With Biopsy Findings and Outcomes in Renal Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delayed Graft Function
Keywords: Renal Biopsy
elevated serum creatinine
proteinuria
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2015-06-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: post-transplant and are undergoing kidney transplant biopsies at the UC Davis transplant center. Ten subjects will be enrolled who are receiving surveillance "protocol biopsies" and 10 subjects who will be receiving "for cause" biopsies in the setting of an elevated serum creatinine or proteinuria. Samples of blood, and formalin-fixed, paraffin-embedded biopsy tissue will be sent to Transplant Genomics INC. (TGI) for study purposes. In addition, clinical data will be collected on each subject.. Blood and tissue will be analyzed by TGI using Affymetrix microarrays, and reports will be sent to UC Davis retrospectively. Samples may be batch-shipped and results will not be reported in real time. These results will be compared to both the histological diagnosis, and to the clinical course.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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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Primary outcomes:
measure: Biopsy prove acute rejection
timeFrame: 12 months
Secondary outcomes:
measure: Gene Expression Profiling
timeFrame: 12 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Transplant Center
state: California
Study officials:
affiliation: University of California, Davis Health Systems
name: Angelo DeMattos, MD
role: PRINCIPAL_INVESTIGATOR
References: