NEPTUNE Match Study
Purpose
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.
Conditions
- Nephrotic Syndrome in Children
- Focal Segmental Glomerulosclerosis
- Minimal Change Disease
- Minimal Change Nephrotic Syndrome
- Membranous Nephropathy
- FSGS
- MCD
- MCD - Minimal Change Disease
- Alport Syndrome
Eligibility
- Eligible Ages
- Between 1 Year and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Potential participants are selected based on enrollment in the NEPTUNE Observational Cohort Study (NEPTUNE) and who are possibly eligible for a NEPTUNE Match sub-study partner trial. These participants will then be "Match"ed to a partner trial based on biomarker validation and this information will be communicated to the participant in a teach-back model to determine effectiveness.
- Primary Purpose
- Other
- Masking
- None (Open Label)
- Masking Description
- No Masking
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Kansas City 4273837, Kansas 4273857 66160
More Details
- Status
- Recruiting
- Sponsor
- University of Michigan
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.