Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT04571658

Conditions

Nephrotic Syndrome in Children

Focal Segmental Glomerulosclerosis

Minimal Change Disease

Minimal Change Nephrotic Syndrome

Membranous Nephropathy

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Not accepted

Interventions

Communication

Study Details

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.

Conditions

Nephrotic Syndrome in Children

Focal Segmental Glomerulosclerosis

Minimal Change Disease

Minimal Change Nephrotic Syndrome

Membranous Nephropathy

Study ID

NCT04571658

Start date

May 2, 2022

Status verified date

Jun, 2026

Completion date

Dec 30, 2029

Anticipated

Primary completion date

Dec 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

375 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Communication

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.

Primary outcome measure

  • Matched participants with at least one clinical trial receive a MNB assessment [ Time Frame: 0-4 weeks ]
  • Efficacy of communication methods at time of communication visit, measured by Teach Back 1 summary score [ Time Frame: 12 weeks ]
  • Kidney health endpoints that are specific to each individual trial [ Time Frame: 0-60 months ]

Central Contacts and Locations

Central contacts

Hailey E Desmond, MS

734-232-4851heturner@med.umich.edu

Chrysta C Lienczewski, BS

734-615-5021boridley@med.umich.edu

Locations

Emory University Hospital - Children's Hospital of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Emily Yun

emily.yun@emory.edu

Principal Investigator:

Laurence Greenbaum, MD, PhD

John H. Stroger, Jr., Hospital of Cook County

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Mathew Itteera

mathew.itteera@cookcountyhhs.org

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Catherine Creed

ccreed@kumc.edu

Principal Investigator:

Ellen McCarthy, MD

Johns Hopkins Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

MIahje Williams

mwil296@jhmi.edu

Principal Investigator:

Meredith Adkinson, MD

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Kelsey Markus

kemarkus@cmh.edu

Principal Investigator:

Tarak Srivastava, MD

Northwell/Cohen's Children's Hospital

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Suzanne Vento, BSN

svento@northwell.edu

Principal Investigator:

Christine Sethna, MD, MS

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Pietro Canetta, MD

University of North Carolina Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Anne Froment

anne_froment@med.unc.edu

Maria Fernanda Ochoa Toro

ferochoc@email.unc.edu

Principal Investigator:

Vimal Derebail, MD, MS

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Stefanie Larson

larsons2@ccf.org

Principal Investigator:

Katherine Dell, MD

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Krishna Kallem, MS

Krishna.Kallem@pennmedicine.upenn.edu

Principal Investigator:

Larry Holzman, MD

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19122

Contacts

Zoe Pfeffer

zoe.pfeffer@tuhs.temple.edu

Principal Investigator:

Iris Lee, MD

Medical University of South Carolina

Recruiting

Charlotte, South Carolina, United States, 29425

Principal Investigator:

David Selewski, MD, MS

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Emily Pao

emily.pao@seattlechildrens.org

Principal Investigator:

Sangeeta Hingorani, MD

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Linda Manahan, BSN

lmanahan@nephrology.washington.edu

Principal Investigator:

Ashley Jefferson, MD

Providence Sacred Heart Medical Center

Recruiting

Spokane, Washington, United States, 99204

Contacts

Kelli Kuykendall

kelli.kuykendall@providence.org

Principal Investigator:

Katherine Tuttle, MD

More Information

Sponsor

University of Michigan

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

  • Nephrotic Syndrome
  • NEPTUNE
  • Match
  • Clinical Trial Match

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-06-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.