NEPTUNE Match Study

Focal Segmental Glomerulosclerosis Clinical Trial

— NEPTUNE Match  

Official title:

Nephrotic Syndrome Study Network (NEPTUNE) Match Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04571658
• Other study ID #: HUM00158219-Sub
• Secondary ID: U54DK083912
• Status: Enrolling by invitation
• Start date: March 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 375
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Focal Segmental Glomerulosclerosis
• FSGS
• Glomerulonephritis, Membranous
• Glomerulosclerosis, Focal Segmental
• MCD
• MCD - Minimal Change Disease
• Membranous Nephropathy
• Minimal Change Disease
• Minimal Change Nephrotic Syndrome
• Nephrosis
• Nephrosis, Lipoid
• Nephrotic Syndrome
• Nephrotic Syndrome in Children
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital - Children's Hospital of Atlanta	Atlanta	Georgia
United States	Johns Hopkins Medicine	Baltimore	Maryland
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	John H. Stroger, Jr., Hospital of Cook County	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Northwell/Cohen's Children's Hospital	New Hyde Park	New York
United States	Columbia University Medical Center	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Temple University	Philadelphia	Pennsylvania
United States	Seattle Children's Hospital	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	Providence Sacred Heart Medical Center	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	14-18 weeks
Secondary	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.	14-18 weeks
Secondary	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.	14-18 weeks

External Links

•   Are physicians and patients in agreement? Exploring dyadic concordance
•   Inflammatory and JAK-STAT Pathways as Shared Molecular Targets for ANCA-Associated Vasculitis and Nephrotic Syndrome
•   Patient information recall in a rheumatology clinic
•   Patients' memory for medical information
•   Redefining Nephrotic Syndrome in Molecular Terms: Outcome-associated molecular clusters and patient stratification with noninvasive surrogate biomarkers
•   Teachback