NEPTUNE Match Study

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

• Registration Number: NCT04571658
• Lead Sponsor: University of Michigan

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-10-01
• Study Start: 2021-03-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 375

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NEPTUNE Match Participants	Communication	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.

Primary Outcome Measures

Name	Time	Method
Matched participants with at least one clinical trial receive a MNB assessment	0-4 weeks	Proportion of NEPTUNE Match participants with at least one matching clinical trial, defined as receiving a Molecular Nephrology Board (MNB) assessment that provides a match to at least one targeted therapy in an ongoing clinical trial
Efficacy of communication methods at time of communication visit, measured by Teach Back 1 summary score	12 weeks	Key findings from MNB trial matching analyses and deliberations will be conveyed to study participants using a NEPTUNE Match Report that summarizes the findings. The report indicates the strength of matching to ongoing clinical trials and the uncertainty and research origins of the information. A sample Match Report can be found in Appendix C. The report will not contain individual data elements reviewed by the MNB. The creation of NEPTUNE Match Reports will follow health education principles including matching of content to patients' informational needs and health literacy levels, use of visual aids to clarify meaning of information, and avoidance of information overload of the participant.
Kidney health endpoints that are specific to each individual trial	0-60 months	The analytic integration supporting the Molecular Nephrology Board (MNB) case review will be initiated and will occur. The MNB will conduct the discussion and generate the integrated data summary and case report inclusive of clinical trial matching by webinar. Input from the MNB will be used to generate a final version of the participant NEPTUNE Match Report. This is a longitudinal outcome that will be assessed at the end of the study relative to endpoints specific to matched clinical trials, assessing the superiority of stratification (matching or alignment of patient molecular profiles to targeted therapies in clinical trials) to non-stratification.

Secondary Outcome Measures

Name	Time	Method
Psychological distress measured by the FACToR-NEPTUNE assessment	14-18 weeks	FACToR-NEPTUNE is a measure that has been modified from the Feelings About genomiC Testing Results (FACToR). FACToR-12 is used to assess the psychosocial impact of returning genomic findings to patients in research and clinical practice. In the FACToR-NEPTUNE assessment the measure will assess the psychosocial impact after receiving the NEPTUNE Match Report.
Efficacy of communication methods at follow up, measured by Teach Back of key concepts	14-18 weeks	3 defined teachback concepts will be scored to indicate the participant's understanding of strength of matching.
Psychological distress measured by the STAI assessment	14-18 weeks	State Trait Anxiety Inventory (mini-STAI) scale will be used to assess a participant's psychological distress around their participation in NEPTUNE Match at the consent visit and the follow up visit.

Trial Locations

Locations (16)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

Northwell/Cohen's Children's Hospital; 🇺🇸 New Hyde Park, New York, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Providence Sacred Heart Medical Center; 🇺🇸 Spokane, Washington, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

John H. Stroger, Jr., Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Emory University Hospital - Children's Hospital of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

University of North Carolina Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Johns Hopkins Medicine; 🇺🇸 Baltimore, Maryland, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States