NEPTUNE Match: Personalized matching of patients to kidney treatment options
Implementing Precision Medicine for Glomerular Diseases in the Nephrotic Syndrome Study Network (NEPTUNE)
This project will try a system that matches people in the NEPTUNE cohort who have nephrotic syndromes or related kidney diseases with suitable clinical trials and shares those matches with patients and their doctors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 375 (estimated) |
| Ages | 1 Year to 80 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 16 sites (Atlanta, Georgia and 15 other locations) |
| Trial ID | NCT04571658 on ClinicalTrials.gov |
What this trial studies
NEPTUNE Match is a prospective, open-label effort that recruits participants from the NEPTUNE observational cohort and creates patient-specific trial match assessments using existing clinical and molecular data reviewed by the NEPTUNE Molecular Nephrology Board. The program will establish and test a communication framework to share disease-to-drug-mechanism matches with treating clinicians and patients. It will then compare kidney health outcomes retrospectively between subjects who enrolled in trials aligned with their match and those with misaligned or unknown match alignment. The goal is to determine if structured matching and targeted communication improves trial alignment and downstream outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals already enrolled in the NEPTUNE observational cohort with nephrotic syndrome or related diagnoses who receive regular nephrology care at a participating NEPTUNE site and meet age and trial-specific eligibility.
Not a fit: People not enrolled in NEPTUNE, those who do not speak English or Spanish, or those outside the age ranges or other criteria of available partnering trials are unlikely to benefit from NEPTUNE Match.
Why it matters
Potential benefit: If successful, patients may have improved access to clinical trials that better match their disease mechanism, potentially increasing the chance of benefiting from targeted therapies.
How similar studies have performed: Matching and precision-referral programs have shown promise in oncology and other fields, but applying biomarker-driven trial matching to nephrotic syndromes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Atlanta, Georgia and 15 other locations
- Emory University Hospital - Children's Hospital of Atlanta — Atlanta, Georgia, United States (Recruiting)
- John H. Stroger, Jr., Hospital of Cook County — Chicago, Illinois, United States (Recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- Johns Hopkins Medicine — Baltimore, Maryland, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Enrolling_by_invitation)
- Children's Mercy Hospital — Kansas City, Missouri, United States (Recruiting)
- Northwell/Cohen's Children's Hospital — New Hyde Park, New York, United States (Recruiting)
- Columbia University Medical Center — New York, New York, United States (Recruiting)
- University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Temple University — Philadelphia, Pennsylvania, United States (Recruiting)
- Medical University of South Carolina — Charlotte, South Carolina, United States (Recruiting)
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
- University of Washington Medical Center — Seattle, Washington, United States (Recruiting)
- Providence Sacred Heart Medical Center — Spokane, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Matthias Kretzler, MD — University of Michigan
- Study coordinator: Hailey E Desmond, MS
- Email: heturner@med.umich.edu
- Phone: 734-232-4851
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.