Nephrotic Syndrome in ChildrenNEPTUNE MatchNCT04571658
NEPTUNE Match Study
A study testing Communication in people with Nephrotic Syndrome in Children and Focal Segmental Glomerulosclerosis, run by University of Michigan at 16 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Nephrotic Syndrome in Children, Focal Segmental Glomerulosclerosis, Minimal Change Disease
- What is being tested?
- Communication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 16 sitesUnited States
- Study dates
- 2 May 2022to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Consented and eligible participants in the biopsied or non-biopsied cohorts of the NEPTUNE observational study
- 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.
- Regular nephrology healthcare provided at a NEPTUNE study site.
- Willing and able to consent, and as appropriate assent, to participate in NEPTUNE Match
Who cannot join
- Currently non-NEPTUNE observational study participants are not eligible to be matched to a clinical trial using these biomarker assessments.
- 1. Non-English or non-Spanish speaking
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 16 recruiting
- Enrolling by invitation
University of Michigan
Ann Arbor, Michigan, 48109
- Recruiting
Emory University Hospital - Children's Hospital of Atlanta
Atlanta, Georgia, 30322
Emily Yun, emily.yun@emory.edu
Laurence Greenbaum, MD, PhD
- Recruiting
Johns Hopkins Medicine
Baltimore, Maryland, 21287
MIahje Williams, mwil296@jhmi.edu
Meredith Adkinson, MD
- Recruiting
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27514
Anne Froment, anne_froment@med.unc.edu
Maria Fernanda Ochoa Toro, ferochoc@email.unc.edu
- Recruiting
Medical University of South Carolina
Charlotte, South Carolina, 29425
David Selewski, MD, MS
- Recruiting
John H. Stroger, Jr., Hospital of Cook County
Chicago, Illinois, 60612
Mathew Itteera, mathew.itteera@cookcountyhhs.org
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44106
Stefanie Larson, larsons2@ccf.org
Katherine Dell, MD
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Catherine Creed, ccreed@kumc.edu
Ellen McCarthy, MD
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Kelsey Markus, kemarkus@cmh.edu
Tarak Srivastava, MD
- Recruiting
Northwell/Cohen's Children's Hospital
New Hyde Park, New York, 11040
Suzanne Vento, BSN, svento@northwell.edu
Christine Sethna, MD, MS
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Anup Pradhan
Pietro Canetta, MD
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Krishna Kallem, MS, Krishna.Kallem@pennmedicine.upenn.edu
Larry Holzman, MD
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19122
Zoe Pfeffer, zoe.pfeffer@tuhs.temple.edu
Iris Lee, MD
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Emily Pao, emily.pao@seattlechildrens.org
Sangeeta Hingorani, MD
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Linda Manahan, BSN, lmanahan@nephrology.washington.edu
Ashley Jefferson, MD
- Recruiting
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
Kelli Kuykendall, kelli.kuykendall@providence.org
Katherine Tuttle, MD
About this study
Official title: Implementing Precision Medicine for Glomerular Diseases in the Nephrotic Syndrome Study Network (NEPTUNE)
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:
- Recruitment of participants from the NEPTUNE observational cohort study
- Generation of participant profile-trial match assessment using data from the NEPTUNE observational study and profiling units by the NEPTUNE Molecular Nephrology Board
- Establishing and testing a framework to communicate disease-trial drug mechanism matching with investigators and patients
- 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.
- Conditions
- Nephrotic Syndrome in Children, Focal Segmental Glomerulosclerosis, Minimal Change Disease, Minimal Change Nephrotic Syndrome, Membranous Nephropathy, FSGS
- Being tested
- Communication
- Keywords
- Nephrotic Syndrome, NEPTUNE, Match, Clinical Trial Match
- Medical subject headings
- Glomerulosclerosis, Focal Segmental, Nephrosis, Lipoid, Glomerulonephritis, Membranous, Macular dystrophy, corneal type 1, Nephritis, Hereditary, Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CommunicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NEPTUNE Match Participants | Other | 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. Receives: Other: Communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-4 weeks
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.
Measured: 12 weeks
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.
Measured: 0-60 months
Secondary outcomes (3)
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.
Measured: 14-18 weeks
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.
Measured: 14-18 weeks
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.
Measured: 14-18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start2 May 2022
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nephrotic Syndrome in ChildrenStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Potential participants are selected based on enrollment in the NEPTUNE Observational Cohort Study (NEPTUNE) and who are possibly eligible for a NEPTUNE Match sub-study partner trial. These participants will then be "Match"ed to a partner trial based on biomarker validation and this information will be communicated to the participant in a teach-back model to determine effectiveness.
- Masking
- None (open label)
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Kretzler, University of Michigan
- Investigators
- Matthias Kretzler, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571658
- Sponsor's protocol ID
- HUM00158219-Sub
- Other IDs
- U54DK083912, R01DK141114
- Acronym
- NEPTUNE Match
- Status last verified
- Jun 2026
- First submitted
- 8 Sep 2020
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 23325076Tao 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 30093081Ha 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 26878928Marteau 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 1393159Tluczek 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Precision Medicine for Glomerular Diseases in the Nephrotic Syndrome Study Network (NEPTUNE)
- ClinicalTrials.gov ID
- NCT04571658
- Acronym / sponsor ID
- NEPTUNE Match / HUM00158219-Sub
- Conditions
- Nephrotic Syndrome in Children, Focal Segmental Glomerulosclerosis, Minimal Change Disease, Minimal Change Nephrotic Syndrome, Membranous Nephropathy, FSGS
- Keywords
- Nephrotic Syndrome, NEPTUNE, Match, Clinical Trial Match
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 2 May 2022 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Recruitment of participants from the NEPTUNE observational cohort study
- Generation of participant profile-trial match assessment using data from the NEPTUNE observational study and profiling units by the NEPTUNE Molecular Nephrology Board
- Establishing and testing a framework to communicate disease-trial drug mechanism matching with investigators and patients
- 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Potential participants are selected based on enrollment in the NEPTUNE Observational Cohort Study (NEPTUNE) and who are possibly eligible for a NEPTUNE Match sub-study partner trial. These participants will then be "Match"ed to a partner trial based on biomarker validation and this information will be communicated to the participant in a teach-back model to determine effectiveness.
| Arm | Type | Receives |
|---|---|---|
| NEPTUNE Match Participants | Other | Other: CommunicationApproximately 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. |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Consented and eligible participants in the biopsied or non-biopsied cohorts of the NEPTUNE observational study
- 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.
- Regular nephrology healthcare provided at a NEPTUNE study site.
- Willing and able to consent, and as appropriate assent, to participate in NEPTUNE Match
Key exclusion criteria (2 listed)
- Currently non-NEPTUNE observational study participants are not eligible to be matched to a clinical trial using these biomarker assessments.
- 1. Non-English or non-Spanish speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CommunicationThe 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. | Other | NEPTUNE Match Participants |
Primary outcome
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
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.
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.
3 secondary outcomes
Efficacy of communication methods at follow up, measured by Teach Back of key concepts
Time frame: 14-18 weeks
Psychological distress measured by the STAI assessment
Time frame: 14-18 weeks
Psychological distress measured by the FACToR-NEPTUNE assessment
Time frame: 14-18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 23325076Gadegbeku 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.
- Background: PubMed 30093081Tao 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.
- Background: PubMed 26878928Ha 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.
- Background: PubMed 1393159Marteau 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.
- Background: PubMed 19902657Tluczek 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.
- Redefining Nephrotic Syndrome in Molecular Terms: Outcome-associated molecular clusters and patient stratification with noninvasive surrogate biomarkersLink provided by the sponsor.
- TeachbackLink provided by the sponsor.
- Are physicians and patients in agreement? Exploring dyadic concordanceLink provided by the sponsor.
- Patients' memory for medical informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthias Kretzler, MD principal investigator
University of Michigan
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication in people with Nephrotic Syndrome in Children and Focal Segmental Glomerulosclerosis, run by University of Michigan at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hailey E Desmond, MS (734-232-4851, heturner@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Matched participants with at least one clinical trial receive a MNB assessment (time frame: 0-4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04571658, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.