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RecruitingNCT04571658NEPTUNE MatchUpdated Nov 10, 2026

NEPTUNE Match Study

An interventional study of Communication in Nephrotic Syndrome in Children, Focal Segmental Glomerulosclerosis and Minimal Change Disease, sponsored by University of Michigan. Recruiting at 16 sites in United States. Open to participants aged 1 Year to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by University of Michigan · Not applicable, Interventional, and Other

From the registry’s dates

  • Started May 2022; still recruiting 4 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
375
Allocation
Not applicable
Ages
1 Year to 80 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Nephrotic Syndrome in Children
  • Focal Segmental Glomerulosclerosis
  • Minimal Change Disease
  • Minimal Change Nephrotic Syndrome
  • Membranous Nephropathy
  • FSGS
  • MCD
  • MCD - Minimal Change Disease
  • Alport Syndrome

Keywords

  • Nephrotic Syndrome
  • NEPTUNE
  • Match
  • Clinical Trial Match
03

In context

Glomerulosclerosis, Focal Segmental

105 studies on the registry are indexed under Glomerulosclerosis, Focal Segmental; 33 are open to participants now.

This study's planned enrollment of 375 is above the median of 30 across 73 interventional studies indexed under Glomerulosclerosis, Focal Segmental.

Browse Glomerulosclerosis, Focal Segmental studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.

Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

Browse University of Michigan studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
375 participants (estimated)

Study arms

  • 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.

    Other: Communication

Interventions

  • OtherCommunication

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 0-4 weeks

  2. 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.

    Time frame: 12 weeks

  3. 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.

    Time frame: 0-60 months

Secondary outcomes

  1. Efficacy of communication methods at follow up, measured by Teach Back of key concepts

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

    Time frame: 14-18 weeks

  2. Psychological distress measured by the STAI assessment

    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.

    Time frame: 14-18 weeks

  3. Psychological distress measured by the FACToR-NEPTUNE assessment

    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.

    Time frame: 14-18 weeks

07

Study locations

16 of 16 sites recruiting
08

References and documents

Publications

  • 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. PubMed 23325076 ↗
  • Tao 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. PubMed 30093081 ↗
  • Ha 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. PubMed 26878928 ↗
  • Marteau 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. PubMed 1393159 ↗
  • Tluczek 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. PubMed 19902657 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2022 (actual). Primary completion is estimated for Dec 2029, 91 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2020
First posted
Oct 1, 2020
StartActual
May 2, 2022
Primary completionEst.
Dec 30, 2029
CompletionEst.
Dec 30, 2029
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and references
1 update, last Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Minor edits only
    + 2 other changes: verification date and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04571658
Lead sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Matthias Kretzler (Internal Medicine Professor, University of Michigan) — Principal investigator
First posted
Oct 1, 2020
Start date
May 2, 2022
Primary completion
Dec 30, 2029 (estimated)
Completion
Dec 30, 2029 (estimated)
Last update
Nov 10, 2026

Study contacts

Hailey E Desmond, MS
Contact
heturner@med.umich.edu
734-232-4851
Chrysta C Lienczewski, BS
Contact
boridley@med.umich.edu
734-615-5021
Matthias Kretzler, MD
principal investigator · University of Michigan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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