NEPTUNE Match Study (NEPTUNE Match)

• ClinicalTrials.gov Identifier: NCT04571658
• Recruitment Status: Enrolling by invitation
• First Posted: October 1, 2020
• Last Update Posted: January 31, 2023
• Sponsor: University of Michigan
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Matthias Kretzler, University of Michigan

Study Description

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.

Condition or disease	Intervention/treatment
Nephrotic Syndrome in Children; Focal Segmental Glomerulosclerosis; Minimal Change Disease; Minimal Change Nephrotic Syndrome; Membranous Nephropathy; FSGS; MCD; MCD - Minimal Change Disease	Other: Communication

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 375 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Nephrotic Syndrome Study Network (NEPTUNE) Match Study
• Actual Study Start Date: March 1, 2021
• Estimated Primary Completion Date: June 30, 2024
• Estimated Study Completion Date: June 30, 2024

Groups and Cohorts

Group/Cohort

Intervention/treatment

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; 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Efficacy of communication methods at follow up, measured by Teach Back of key concepts [ Time Frame: 14-18 weeks ]
   3 defined teachback concepts will be scored to indicate the participant's understanding of strength of matching.
2. Psychological distress measured by the STAI assessment [ Time Frame: 14-18 weeks ]
   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.
3. Psychological distress measured by the FACToR-NEPTUNE assessment [ Time Frame: 14-18 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 0 Years to 85 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the NEPTUNE observational cohort within NEPTUNE clinical sites by trained and experienced study teams. Enrollment into the NEPTUNE observational cohorts and NEPTUNE Match will be ongoing, parallel activities. However participants must be confirmed eligible for inclusion in the NEPTUNE observational study before they are enrolled into NEPTUNE Match. If a NEPTUNE observational study participant previously completed the final NEPTUNE visit, they may undergo a re-enrollment visit in the NEPTUNE III observational study as NEPTUNE III will be open to prevalent patients.

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

Contacts and Locations

Locations

United States, Georgia

Emory University Hospital - Children's Hospital of Atlanta

Atlanta, Georgia, United States, 30322

United States, Illinois

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

Chicago, Illinois, United States, 60612

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

United States, Maryland

Johns Hopkins Medicine

Baltimore, Maryland, United States, 21287

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

United States, Missouri

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

United States, New York

Northwell/Cohen's Children's Hospital

New Hyde Park, New York, United States, 11040

Columbia University Medical Center

New York, New York, United States, 10032

United States, North Carolina

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States, 27514

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44106

United States, Pennsylvania

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Temple University

Philadelphia, Pennsylvania, United States, 19122

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

United States, Washington

Seattle Children's Hospital

Seattle, Washington, United States, 98105

University of Washington Medical Center

Seattle, Washington, United States, 98195

Providence Sacred Heart Medical Center

Spokane, Washington, United States, 99204

Sponsors and Collaborators

University of Michigan

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Matthias Kretzler, MD; University of Michigan
• Study Director: Debbie GIpson, MD, MS; University of Michigan

More Information

Additional Information:

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 

Patient information recall in a rheumatology clinic 

Inflammatory and JAK-STAT Pathways as Shared Molecular Targets for ANCA-Associated Vasculitis and Nephrotic Syndrome 

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.

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.

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.

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. Erratum In: Br J Clin Psychol. 2020 Jun;59(2):276.

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.

• Responsible Party: Matthias Kretzler, Internal Medicine Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT04571658
• Other Study ID Numbers: HUM00158219-Sub; U54DK083912 ( U.S. NIH Grant/Contract )
• First Posted: October 1, 2020
• Last Update Posted: January 31, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matthias Kretzler, University of Michigan:

Nephrotic Syndrome; NEPTUNE; Match; Clinical Trial Match

Additional relevant MeSH terms:

Nephrotic Syndrome; Nephrosis; Glomerulonephritis, Membranous; Glomerulosclerosis, Focal Segmental; Nephrosis, Lipoid; Syndrome; Disease; Pathologic Processes; Kidney Diseases; Urologic Diseases; Glomerulonephritis; Nephritis; Autoimmune Diseases; Immune System Diseases