NEPTUNE Match Study
NEPTUNE Match
Implementing Precision Medicine for Glomerular Diseases in the Nephrotic Syndrome Study Network (NEPTUNE)
2 other identifiers
interventional
375
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2020
CompletedFirst Posted
Study publicly available on registry
October 1, 2020
CompletedStudy Start
First participant enrolled
May 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2029
May 6, 2026
May 1, 2026
7.7 years
September 8, 2020
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Matched participants with at least one clinical trial receive a MNB assessment
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
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
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 Outcomes (3)
Efficacy of communication methods at follow up, measured by Teach Back of key concepts
14-18 weeks
Psychological distress measured by the STAI assessment
14-18 weeks
Psychological distress measured by the FACToR-NEPTUNE assessment
14-18 weeks
Study Arms (1)
NEPTUNE Match Participants
OTHERApproximately 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Currently non-NEPTUNE observational study participants are not eligible to be matched to a clinical trial using these biomarker assessments.
- \. Non-English or non-Spanish speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Emory University Hospital - Children's Hospital of Atlanta
Atlanta, Georgia, 30322, United States
John H. Stroger, Jr., Hospital of Cook County
Chicago, Illinois, 60612, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Johns Hopkins Medicine
Baltimore, Maryland, 21287, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Northwell/Cohen's Children's Hospital
New Hyde Park, New York, 11040, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44106, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Temple University
Philadelphia, Pennsylvania, 19122, United States
Medical University of South Carolina
Charlotte, South Carolina, 29425, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Providence Sacred Heart Medical Center
Spokane, Washington, 99204, United States
Related Publications (5)
Gadegbeku CA, Gipson DS, Holzman LB, Ojo AO, Song PX, Barisoni L, Sampson MG, Kopp JB, Lemley KV, Nelson PJ, Lienczewski CC, Adler SG, Appel GB, Cattran DC, Choi MJ, Contreras G, Dell KM, Fervenza FC, Gibson KL, Greenbaum LA, Hernandez JD, Hewitt SM, Hingorani SR, Hladunewich M, Hogan MC, Hogan SL, Kaskel FJ, Lieske JC, Meyers KE, Nachman PH, Nast CC, Neu AM, Reich HN, Sedor JR, Sethna CB, Trachtman H, Tuttle KR, Zhdanova O, Zilleruelo GE, Kretzler M. Design of the Nephrotic Syndrome Study Network (NEPTUNE) to evaluate primary glomerular nephropathy by a multidisciplinary approach. Kidney Int. 2013 Apr;83(4):749-56. doi: 10.1038/ki.2012.428. Epub 2013 Jan 16.
PMID: 23325076BACKGROUNDTao J, Mariani L, Eddy S, Maecker H, Kambham N, Mehta K, Hartman J, Wang W, Kretzler M, Lafayette RA. JAK-STAT signaling is activated in the kidney and peripheral blood cells of patients with focal segmental glomerulosclerosis. Kidney Int. 2018 Oct;94(4):795-808. doi: 10.1016/j.kint.2018.05.022. Epub 2018 Aug 6.
PMID: 30093081BACKGROUNDHa Dinh TT, Bonner A, Clark R, Ramsbotham J, Hines S. The effectiveness of the teach-back method on adherence and self-management in health education for people with chronic disease: a systematic review. JBI Database System Rev Implement Rep. 2016 Jan;14(1):210-47. doi: 10.11124/jbisrir-2016-2296.
PMID: 26878928BACKGROUNDMarteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x. Erratum In: Br J Clin Psychol. 2020 Jun;59(2):276. doi: 10.1111/bjc.12243.
PMID: 1393159BACKGROUNDTluczek A, Henriques JB, Brown RL. Support for the reliability and validity of a six-item state anxiety scale derived from the State-Trait Anxiety Inventory. J Nurs Meas. 2009;17(1):19-28. doi: 10.1891/1061-3749.17.1.19.
PMID: 19902657BACKGROUND
Related Links
- Redefining Nephrotic Syndrome in Molecular Terms: Outcome-associated molecular clusters and patient stratification with noninvasive surrogate biomarkers
- Teachback
- Are physicians and patients in agreement? Exploring dyadic concordance
- Patients' memory for medical information
- Inflammatory and JAK-STAT Pathways as Shared Molecular Targets for ANCA-Associated Vasculitis and Nephrotic Syndrome
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthias Kretzler, MD
University of Michigan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- No Masking
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Internal Medicine Professor
Study Record Dates
First Submitted
September 8, 2020
First Posted
October 1, 2020
Study Start
May 2, 2022
Primary Completion (Estimated)
December 30, 2029
Study Completion (Estimated)
December 30, 2029
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share