NEPTUNE Match Study (NEPTUNE Match)

June 8, 2026 updated by: Matthias Kretzler, University of Michigan

Implementing Precision Medicine for Glomerular Diseases in the Nephrotic Syndrome Study Network (NEPTUNE)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

375

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital - Children's Hospital of Atlanta
        • Principal Investigator:
          • Laurence Greenbaum, MD, PhD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • Ellen McCarthy, MD
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Medicine
        • Contact:
        • Principal Investigator:
          • Meredith Adkinson, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Enrolling by invitation
        • University of Michigan
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospital
        • Principal Investigator:
          • Tarak Srivastava, MD
        • Contact:
    • New York
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • Northwell/Cohen's Children's Hospital
        • Contact:
        • Principal Investigator:
          • Christine Sethna, MD, MS
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
          • Anup Pradhan
        • Principal Investigator:
          • Pietro Canetta, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Katherine Dell, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19122
    • South Carolina
      • Charlotte, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • David Selewski, MD, MS
    • Washington
      • Seattle, Washington, United States, 98195
      • Seattle, Washington, United States, 98105
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Sacred Heart Medical Center
        • Principal Investigator:
          • Katherine Tuttle, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Participants will be recruited from the NEPTUNE observational cohort within NEPTUNE clinical sites by trained and experienced study teams. Enrollment into the NEPTUNE observational cohorts and NEPTUNE Match will be ongoing, parallel activities. However participants must be confirmed eligible for inclusion in the NEPTUNE observational study before they are enrolled into NEPTUNE Match. If a NEPTUNE observational study participant previously completed the final NEPTUNE visit, they may undergo a re-enrollment visit in the NEPTUNE III observational study as NEPTUNE III will be open to prevalent patients.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: NEPTUNE Match Participants

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.
Other: Communication
The NEPTUNE Match study includes an interdisciplinary Communication Team that will translate findings from the Molecular Nephrology Board (MNB) to inform patients of the matching assessment with ongoing clinical trials. This team has considerable experience with conveying complex biomedical research information to patients and families and includes experts in precision nephrology, nephrology patient [adult and pediatric] communication, and health education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Matched participants with at least one clinical trial receive a MNB assessment
Time Frame: 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
0-4 weeks
Efficacy of communication methods at time of communication visit, measured by Teach Back 1 summary score
Time Frame: 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.
12 weeks
Kidney health endpoints that are specific to each individual trial
Time Frame: 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.
0-60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of communication methods at follow up, measured by Teach Back of key concepts
Time Frame: 14-18 weeks
3 defined teachback concepts will be scored to indicate the participant's understanding of strength of matching.
14-18 weeks
Psychological distress measured by the STAI assessment
Time Frame: 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.
14-18 weeks
Psychological distress measured by the FACToR-NEPTUNE assessment
Time Frame: 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.
14-18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Matthias Kretzler, MD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2022

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

September 25, 2020

First Posted (Actual)

October 1, 2020

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00158219-Sub
  • U54DK083912 (U.S. NIH Grant/Contract)
  • R01DK141114 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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