NEPTUNE Match Study

University of Michigan

Status: Invitation-only

Conditions: Minimal Change Nephrotic Syndrome; Nephrotic Syndrome in Children; Minimal Change Disease; Membranous Nephropathy; MCD - Minimal Change Disease; FSGS; MCD; Focal Segmental Glomerulosclerosis

Treatments: Other: Communication

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04571658

U54DK083912 (U.S. NIH Grant/Contract)

HUM00158219-Sub

Details and patient eligibility

About

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.

Full 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.

Enrollment: 375 estimated patients

Sex: All

Ages: Under 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

375 participants in 1 patient group

NEPTUNE Match Participants

Description:

Approximately 375 participants will be consented from the NEPTUNE observational study with age and demographic groups representing the patient population in the NEPTUNE study site geographical areas. NEPTUNE observational cohort eligibility includes: participants in NEPTUNE observational cohort A are of any age and have a biopsy-confirmed diagnosis of Focal Segmental Glomerulosclerosis (FSGS), Minimal Change Disease (MCD), or Membranous Nephropathy (MN). Participants in NEPTUNE observational cohort B have documented NS based on proteinuria, serum albumin, and/or edema with age of onset less than 19 years.

Treatment:

Other: Communication