Correlation of Molecular Biomarkers With Biopsy Findings... | NCT02463253

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

NCT02463253

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

May 25, 2016Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Delayed Graft Function

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Apr 22, 2015

First Submission Date that Met QC Criteria

Jun 1, 2015

First Posted Date

Jun 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2016

Last Update Posted Date

May 25, 2016Estimated

Name	Class
Northwestern University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Patients who meet all of the following criteria are eligible for enrollment as study participants:

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.

Exclusion Criteria:

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

-

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

82 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Name	Affiliation	Role
Angelo DeMattos, MD	University of California, Davis Health Systems	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of California, Davis Transplant Center		Sacramento	California	95817	United States

ID	Term
D051799	Delayed Graft Function
D011507	Proteinuria

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014555	Urination Disorders
D014570	Urologic Diseases

Description

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

Hematology: Routine hematological parameters will be analyzed as indicated by standard clinical care
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