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

NCT02463253 | Completed DMC

• 1 other identifier: 665869
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Delayed Graft Function

Keywords

Renal Biopsy; elevated serum creatinine; proteinuria

Outcome Measures

Primary Outcomes (1)

• Biopsy prove acute rejection

  Incidence of acute rejection at the time of any kidney biopsy

  12 months

Secondary Outcomes (1)

• Gene Expression Profiling

  12 months

Study Arms (1)

Phase 1

A. 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. B. STUDY DESIGN: Enroll 20 subjects who are 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.

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male and female recipients of all races, ≥18 years of age.
• Patients undergoing primary or subsequent deceased-donor or living donor kidney transplantation.
• Subject and/or guardian must be able to provide informed consent.
• Subject and/or guardian must be able to comply with the study protocol.

You may not qualify if:

• Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
• Recipients of previous non-renal solid organ and/or islet cell transplantation
• Infection with HIV.
• Inability or unwillingness of a participant and/or guardian to provide informed consent

Sponsors & Collaborators

• University of California, Davis: lead
• Northwestern University: collaborator

Study Sites (1)

University of California, Davis Transplant Center

Sacramento, California, 95817, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Laboratory evaluations: The UC Davis laboratory will be used for clinical chemistry, and hematology, as well as other outside laboratories that the participants may go to 1. Hematology: Routine hematological parameters will be analyzed as indicated by standard clinical care 2. Clinical chemistry: Routine clinical chemistry parameters will be analyzed including basic and comprehensive metabolic profiles as indicated by standard clinical care Immunologic Profiles: As per standard routine monitoring with both indicated and surveillance biopsies, donor specific antibodies will be monitored

MeSH Terms

Conditions

Delayed Graft Function; Proteinuria

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms

Study Officials

• Angelo DeMattos, MD

  University of California, Davis Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: June 4, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 25, 2016

Record last verified: 2016-05

Locations

US (1)