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NCT04571658NARecruiting

NEPTUNE Match Study

University of Michigan

Start Date

5/2/2022

Completion Date

12/30/2029

Summary

NEPTUNE Match is an additional opportunity offered to NEPTUNE study participants to prospectively recruit and communicate patient-specific clinical trial matching with kidney patients and their physician investigators.

Detailed Description

This is a prospective, open-label study testing the ability to effectively communicate patient-specific clinical trial matching with kidney patients and clinician investigators. The study consists of four components: 1. Recruitment of participants from the NEPTUNE observational cohort study 2. Generation of participant profile-trial match assessment using data from the NEPTUNE observational study and profiling units by the NEPTUNE Molecular Nephrology Board 3. Establishing and testing a framework to communicate disease-trial drug mechanism matching with investigators and patients 4. Retrospective comparison of kidney health outcomes in subjects enrolled in trials that aligned with their match vs. trial subjects with mis-aligned or unknown match alignment.

Eligibility Criteria

Age Range: 1 years to 80 years

Inclusion Criteria: 1. Consented and eligible participants in the biopsied or non-biopsied cohorts of the NEPTUNE observational study 2. Must be potentially eligible for the NEPTUNE Match partnering trials (e.g. if no trial is enrolling a participant under age 6, those under 6 are not eligible). Note: NEPTUNE Match partnering trials and associated eligibility criteria are expected to be dynamic and change as trial protocols are developed, activated, and amended. 3. Regular nephrology healthcare provided at a NEPTUNE study site. 4. Willing and able to consent, and as appropriate assent, to participate in NEPTUNE Match Exclusion Criteria: Currently non-NEPTUNE observational study participants are not eligible to be matched to a clinical trial using these biomarker assessments. Exclusion Criteria: 1\. Non-English or non-Spanish speaking

Interventions

OTHER

Communication

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Conditions

Nephrotic Syndrome in ChildrenFocal Segmental GlomerulosclerosisMinimal Change DiseaseMinimal Change Nephrotic SyndromeMembranous NephropathyFSGSMCDMCD - Minimal Change DiseaseAlport Syndrome

Locations

Emory University Hospital - Children's Hospital of Atlanta

Atlanta, Georgia 30322

United States

John H. Stroger, Jr., Hospital of Cook County

Chicago, Illinois 60612

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Johns Hopkins Medicine

Baltimore, Maryland 21287

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Children's Mercy Hospital

Kansas City, Missouri 64108

United States

Northwell/Cohen's Children's Hospital

New Hyde Park, New York 11040

United States

Columbia University Medical Center

New York, New York 10032

United States

University of North Carolina Chapel Hill

Chapel Hill, North Carolina 27514

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44106

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Temple University

Philadelphia, Pennsylvania 19122

United States

Medical University of South Carolina

Charlotte, South Carolina 29425

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States

University of Washington Medical Center

Seattle, Washington 98195

United States

Providence Sacred Heart Medical Center

Spokane, Washington 99204

United States