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.

NEPTUNE Match Study

Nephrotic Syndrome in Children

Focal Segmental Glomerulosclerosis

Minimal Change Disease

Minimal Change Nephrotic Syndrome

Membranous Nephropathy

FSGS

MCD - Minimal Change Disease

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.

Communication

Nephrotic Syndrome Study Network (NEPTUNE) Match Study

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

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.

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.

Internal Medicine Professor

3 defined teachback concepts will be scored to indicate the participant's understanding
of strength of matching.

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.

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.

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.

NEPTUNE Match Study

About this trial

Study ID

Status

Type

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the Participation Requirements?

Locations

Location

Status