Correlation of Molecular Biomarkers With Biopsy Findings and Outcomes in Renal Transplant Recipients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02463253

Enrollment

Registered

2015-06-04

Start date

2015-04-30

Completion date

2016-05-31

Last updated

2016-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed Graft Function

Keywords

Renal Biopsy, elevated serum creatinine, proteinuria

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 82 Years

Healthy volunteers

Yes

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 \-

Design outcomes

Primary

Measure	Time frame	Description
Biopsy prove acute rejection	12 months	Incidence of acute rejection at the time of any kidney biopsy

Secondary

Measure	Time frame	Description
Gene Expression Profiling	12 months	Blood and tissue collection from each subject at the time of each for cause or protocol kidney biopsy

Countries

United States

Outcome results