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NCT Number: NCT04571658

NEPTUNE Match Study

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.

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Key information

Conditions

Nephrotic Syndrome in Children Alport Syndrome Autoimmune Diseases Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases FSGS Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Focal Segmental Glomerulosclerosis Glomerulonephritis Glomerulonephritis, Membranous Glomerulosclerosis, Focal Segmental Immune System Diseases Kidney Diseases MCD MCD - Minimal Change Disease Macular dystrophy, corneal type 1 Male Urogenital Diseases Membranous Nephropathy Minimal Change Disease Minimal Change Nephrotic Syndrome Nephritis Nephritis, Hereditary Nephrosis Nephrosis, Lipoid Nephrotic Syndrome Skin and Connective Tissue Diseases Urogenital Abnormalities Urogenital Diseases Urologic Diseases

Age range

1 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

About this study

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:

  • Recruitment of participants from the NEPTUNE observational cohort study
  • Generation of participant profile-trial match assessment using data from the NEPTUNE observational study and profiling units by the NEPTUNE Molecular Nephrology Board
  • Establishing and testing a framework to communicate disease-trial drug mechanism matching with investigators and patients
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consented and eligible participants in the biopsied or non-biopsied cohorts of the NEPTUNE observational study
  • 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.

  • Regular nephrology healthcare provided at a NEPTUNE study site.
  • 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

  • Non-English or non-Spanish speaking

Treatment and study plan

Communication

Other

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chrysta C Lienczewski, BS

CONTACT

[email protected]

734-615-5021

Hailey E Desmond, MS

CONTACT

[email protected]

734-232-4851

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Official study title

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

Acronym: NEPTUNE Match

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Oct 1, 2020
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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