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NEPTUNE Match Study (NEPTUNE Match)

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ClinicalTrials.gov Identifier: NCT04571658
Recruitment Status : Enrolling by invitation
First Posted : October 1, 2020
Last Update Posted : March 9, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Matthias Kretzler, University of Michigan

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.

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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


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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04571658


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Matthias Kretzler, MD University of Michigan
Study Director: Debbie GIpson, MD, MS University of Michigan
Additional Information:
Publications:

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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    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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