PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease

September 15, 2026 updated by: Boehringer Ingelheim

PODOMOUNT-Basket, a Phase II, Multicentre, Randomised, 2-arm Parallel-group, Double-blind, Placebo-controlled Basket Trial to Assess Safety, Tolerability, PK, and Efficacy of BI 764198 in Four Proteinuric Kidney Diseases

This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions.

Participants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group.

Participants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1407
      • Ciudad Autonoma Buenos Aires, Argentina, C1425AGC
      • Córdoba, Argentina, 5000
      • San Isidro, Argentina, B1642DCD
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Not yet recruiting
        • Concord Repatriation General Hospital
        • Contact:
      • Kingswood, New South Wales, Australia, 2747
      • New Lambton Heights, New South Wales, Australia, 2305
    • Queensland
      • Brisbane, Queensland, Australia, 4029
      • Woolloongabba, Queensland, Australia, 4102
  • Belgium
      • Aalst, Belgium, 9300
      • Brussels, Belgium, 1070
      • Ghent, Belgium, 9000
      • Leuven, Belgium, 3000
  • Brazil
      • Fortaleza, Brazil, 60110-110
        • Recruiting
        • Universidade Federal do Ceara
        • Contact:
      • Porto Alegre, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Contact:
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
        • Contact:
      • São Paulo, Brazil, 05403-901
        • Not yet recruiting
        • Instituto da Crianca e do Adolescente
        • Contact:
      • São Paulo, Brazil, 04038-002
        • Recruiting
        • Fundacao Oswaldo Ramos (Hospital do Rim)
        • Contact:
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4L7
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Victoria Hospital (LHSC)
        • Contact:
    • Quebec
      • Monteral, Quebec, Canada, H1T 2M4
        • Not yet recruiting
        • Maisonneuve-Rosemont Hospital
        • Contact:
  • China
      • Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
      • Beijing, China, 102218
        • Recruiting
        • Beijing Tsinghua Changgung Hospital
        • Contact:
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
      • Guangzhou, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
      • Nanchang, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanjing, China, 210009
        • Recruiting
        • Zhongda Hospital Southeast University
        • Contact:
      • Nanning, China, 530000
        • Recruiting
        • The First People's Hospital of Nanning
        • Contact:
      • Shanghai, China, 200080
        • Recruiting
        • Shanghai General Hospital
        • Contact:
      • Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Sichuan, China, 610031
        • Recruiting
        • People's Hospital of Sichuan Province
        • Contact:
      • Wuhan, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
      • Xiamen, China, 361004
        • Recruiting
        • Zhongshan Hospital Affiliated to Xiamen University
        • Contact:
  • Croatia
      • Rijeka, Croatia, 51000
      • Vinkovci, Croatia, 32100
      • Zagreb, Croatia, 10000
      • Zagreb, Croatia, 10000
      • Zagreb, Croatia, 10000
  • Denmark
      • Roskilde, Denmark, 4000
        • Not yet recruiting
        • Zealand University Hospita; Roskilde
        • Contact:
  • Estonia
      • Tartu, Estonia, 50406
        • Not yet recruiting
        • Tartu University Hospital
        • Contact:
  • France
      • Amiens, France, 80054
      • Bordeaux, France, 33076
      • Créteil, France, 94000
      • Nice, France, 06000
      • Paris, France, 75015
  • Germany
      • Berlin, Germany, 10249
        • Not yet recruiting
        • Vivantes Klinikum im Friedrichshain
        • Contact:
      • Cologne, Germany, 50937
      • Hamburg, Germany, 20246
        • Not yet recruiting
        • Universitätsklinikum Hamburg, Eppendorf
        • Contact:
      • Hamburg, Germany, 20246
      • Hanover, Germany, 30625
      • Mainz, Germany, 55131
        • Not yet recruiting
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Contact:
      • München, Germany, 81675
        • Not yet recruiting
        • Klinikum rechts der Isar der Technischen Universität München
        • Contact:
  • Greece
      • Heraklion, Greece, 71500
        • Not yet recruiting
        • University General Hospital of Heraklion
        • Contact:
      • Pátrai, Greece, 265 04
        • Not yet recruiting
        • General University Hospital of Patras
        • Contact:
  • India
      • Ahmedabad, India, 380015
        • Not yet recruiting
        • Aartham Multi Super Speciality Hospital
        • Contact:
      • Bhubaneswar, India, 751019
        • Not yet recruiting
        • AIIMS Bhubaneshwar
        • Contact:
      • Hyderabad, India, 500082
        • Not yet recruiting
        • Nizam's Institute of Medical Sciences
        • Contact:
      • Hyderabad, India, 500012
        • Not yet recruiting
        • Osmania Medical College & Hospital
        • Contact:
      • Kozhikode, India, 673008
        • Not yet recruiting
        • Government Medical College
        • Contact:
      • Lucknow, India, 226014
        • Not yet recruiting
        • Sanjay Gandhi Post Graduate Institute of Medical Sciences
        • Contact:
      • Mysore, India, 570015
        • Not yet recruiting
        • JSS Medical College
        • Contact:
      • Pune, India, 411013
        • Not yet recruiting
        • Noble Hospital Pvt Ltd
        • Contact:
      • Varanasi, India, 201010
        • Not yet recruiting
        • Galaxy Lifecare Services Pvt. Ltd.
        • Contact:
  • Italy
      • Ancona, Italy, 60126
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria Delle Marche
        • Contact:
      • Bari, Italy, 70124
        • Not yet recruiting
        • Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
        • Contact:
      • Bologna, Italy, 40138
        • Recruiting
        • Policlinico S. Orsola-Malpighi
        • Contact:
      • Messina, Italy, 98124
        • Not yet recruiting
        • A.O.U.Policlinico G.Martino
        • Contact:
      • Milan, Italy, 20142
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione Salvatore Maugeri
        • Contact:
      • San Giovanni Rotondo (FG), Italy, 71013
        • Not yet recruiting
        • IRCCS Ospedale "Casa Sollievo della Sofferenza"
        • Contact:
      • Verona, Italy, 37126
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona
        • Contact:
  • Japan
      • Aichi, Kasugai, Japan, 486-8510
        • Recruiting
        • Kasugai Municipal Hospital
        • Contact:
      • Aichi, Nagoya, Japan, 466-8650
        • Recruiting
        • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
        • Contact:
      • Fukuoka, Fukuoka, Japan, 815-8555
        • Recruiting
        • Japanese Red Cross Fukuoka Hospital
        • Contact:
      • Hyogo, Kobe, Japan, 650-0017
        • Recruiting
        • Kobe University Hospital
        • Contact:
      • Tokyo, Minato-ku, Japan, 105-8471
        • Recruiting
        • The Jikei University Hospital
        • Contact:
      • Tokyo, Shinjuku-ku, Japan, 162-8666
        • Recruiting
        • Tokyo Women's Medical University Hospital
        • Contact:
  • Malaysia
      • Batu Caves, Malaysia, 68100
      • Kajang, Malaysia, 43000
        • Recruiting
        • Hospital Sultan Idris Shah Serdang
        • Contact:
      • Selangor Darul Ehsan, Malaysia, 47500
  • Mexico
      • Aguascalientes, Mexico, 20259
        • Not yet recruiting
        • Centenario Hospital Miguel Hidalgo
        • Contact:
      • Mexico City, Mexico, 03650
      • Mexico City, Mexico, 14080
        • Not yet recruiting
        • Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
        • Contact:
      • Mexico City, Mexico, 03100
        • Not yet recruiting
        • Health Pharma Professional Research S.A. de C.V.
        • Contact:
      • Monterrey, Mexico, 64060
        • Not yet recruiting
        • Servicios de Oncología Medica Integral, S.A de C.V. Sucursal Renal
        • Contact:
      • Tlalpan, Mexico, 14080
        • Not yet recruiting
        • Instituto Nacional de Cardiologia Ignacio Chavez
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
      • Groningen, Netherlands, 9713 GZ
        • Not yet recruiting
        • Universitair Medisch Centrum Groningen
        • Contact:
  • New Zealand
      • Auckland, New Zealand, 622
        • Recruiting
        • Pacific Clinical Research Network - Auckland
        • Contact:
      • Hamilton, New Zealand, 3204
  • Norway
      • Lørenskog, Norway, 1478
        • Recruiting
        • Akershus Universitetssykehus HF
        • Contact:
      • Oslo, Norway, 0450
        • Recruiting
        • Oslo Universitetssykehus HF, Ulleval sykehus
        • Contact:
      • Stavanger, Norway, N-4011
        • Not yet recruiting
        • Helse Stavanger, Stavanger Universitetssykehus
        • Contact:
      • Tromsø, Norway, 9019
        • Not yet recruiting
        • Universitetssykehuset Nord-Norge, Tromso
        • Contact:
  • Poland
      • Lodz, Poland, 92-213
        • Not yet recruiting
        • Central Clinical Hospital of the Medical University of Lodz
        • Contact:
      • Poznan, Poland, 60-355
        • Not yet recruiting
        • Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
        • Contact:
      • Szczecin, Poland, 70-111
        • Not yet recruiting
        • Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
        • Contact:
      • Warsaw, Poland, 04-141
        • Recruiting
        • Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
        • Contact:
      • Warsaw, Poland, 02-091
        • Not yet recruiting
        • Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie
        • Contact:
  • Portugal
      • Almada, Portugal, 2805-267
        • Recruiting
        • Unidade Local de Saúde de Almada-Seixal E.P.E.
        • Contact:
      • Braga, Portugal, 4710-243
      • Lisbon, Portugal, 1649-035
      • Lisbon, Portugal, 2790-134
        • Recruiting
        • Unidade Local de Saúde Lisboa Occidental, E.P.E
        • Contact:
      • Loures, Portugal, 2674-514
  • Romania
      • Bucharest, Romania, 022328
      • Timișoara, Romania, 300723
        • Recruiting
        • County Emergency Hospital "Pius Brinzeu" Timisoara
        • Contact:
  • Singapore
      • Singapore, Singapore, 169608
      • Singapore, Singapore, 308433
  • Slovakia
      • Banská Bystrica, Slovakia, 975 17
        • Not yet recruiting
        • F D Roosevelt University General Hospital Of Banska Bystrica
        • Contact:
      • Bratislava, Slovakia, 833 05
        • Not yet recruiting
        • University Hospital and Comenius University in Bratislava, Derer´s Hospital
        • Contact:
      • Košice, Slovakia, 04011
        • Recruiting
        • Univerzitna nemocnica L. Pasteura Kosice
        • Contact:
      • Košice, Slovakia, 40190
        • Not yet recruiting
        • FMC Dialysis Services Kosice
        • Contact:
      • Martin, Slovakia, 036 01
  • South Korea
      • Seoul, South Korea, 05278
        • Recruiting
        • Kyung Hee University Hospital at Gangdong
        • Contact:
      • Suwon, South Korea, 16499
        • Recruiting
        • Ajou University Hospital
        • Contact:
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
      • Esplugues de Llobregat, Spain, 08950
        • Not yet recruiting
        • Hospital Sant Joan de Déu
        • Contact:
      • Granada, Spain, 18014
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Valencia, Spain, 46010
        • Not yet recruiting
        • Hospital Clinico De Valencia (INCLIVA)
        • Contact:
  • Sweden
      • Danderyd, Sweden, 182 88
      • Linköping, Sweden, 581 85
        • Recruiting
        • Universitetssjukhuset Linköping
        • Contact:
      • Uppsala, Sweden, 751 85
  • Switzerland
      • Zurich, Switzerland, 8032
  • Taiwan
      • New Taipei City, Taiwan, 235
        • Recruiting
        • Taipei Medical University-Shuang Ho Hospital
        • Contact:
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
        • Contact:
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01220
        • Not yet recruiting
        • Adana City Hospital
        • Contact:
      • Ankara, Turkey (Türkiye), 06200
        • Not yet recruiting
        • Ankara Etlik City Hospital
        • Contact:
      • Bursa, Turkey (Türkiye), 16110
        • Not yet recruiting
        • Bursa Uludag University
        • Contact:
      • Istanbul, Turkey (Türkiye), 34093
        • Not yet recruiting
        • Istanbul Capa University
        • Contact:
      • Melikgazi/Kayseri, Turkey (Türkiye), 38039
      • İzmit, Turkey (Türkiye), 41000
        • Not yet recruiting
        • Kocaeli University Faculty of Medicine Hospital
        • Contact:
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
      • London, United Kingdom, SE5 9RS
      • London, United Kingdom, E1 1BB
      • Salford, United Kingdom, M6 8HD
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
    • California
      • Glendale, California, United States, 91206
      • Granada Hills, California, United States, 91344
      • Los Angeles, California, United States, 90095
      • Los Angeles, California, United States, 90022
        • Recruiting
        • Academic Medical Research Institute - Glendale
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80220
    • Florida
      • Boca Raton, Florida, United States, 33487
      • Fort Lauderdale, Florida, United States, 33316
        • Recruiting
        • Florida Kidney Physicians, LLC - Fort Lauderdale
        • Contact:
      • Miami, Florida, United States, 33126
      • Orlando, Florida, United States, 32806
      • Riverview, Florida, United States, 33578
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Contact:
      • Evanston, Illinois, United States, 60201
    • Maryland
      • Baltimore, Maryland, United States, 21287
    • Michigan
      • Shelby, Michigan, United States, 48315
        • Recruiting
        • St. Clair Nephrology Research, LLC - Shelby Township
        • Contact:
    • New York
      • Clifton Park, New York, United States, 12065
        • Recruiting
        • New York Nephrology and Dialysis Access Surgery, PC
        • Contact:
      • Fresh Meadows, New York, United States, 11366
      • Mineola, New York, United States, 11501
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Cleveland, Ohio, United States, 44195
      • Columbus, Ohio, United States, 43205
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
    • Texas
      • Dallas, Texas, United States, 75231
      • Houston, Texas, United States, 77027
    • West Virginia
      • Morgantown, West Virginia, United States, 26506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent/assent (Visit 1)
  • Body Mass Index (BMI) of ≤40 kg/m2 at screening visit (Visit 1)
  • Weight of ≥40 kg at screening

  • Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit

    • For adult participants (≥18); ≥25 mL/min/1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit
    • For adolescent participants (<18); ≥25 mL/min/1.73 m2 (chronic kidey disease under 25 years (CKiD U25) formula using height and serum cystatin C) at the screening visit
  • Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants <18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and "true" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants <18)
  • Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not tolerated or indicated as per the discretion of the investigator
  • If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a stable dose for at least 8 weeks prior to the screening visit (Visit 1), preferably with no plan to change the dose until the end of the randomised double-blind treatment period (i.e. EoT, Week 20)
  • Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil/-sodium, cyclophosphamide) must be on a stable dose for at least 12 weeks prior to the screening visit (Visit 1) with no plans to change their dose during the trial treatment period
  • Patients treated/to be treated with oral glucocorticoids have to be at a dose ≤10 mg/d prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period.

Further inclusion criteria apply.

Exclusion Criteria:

  • A history of organ transplantation or planned transplantation during the course of the study
  • Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)
  • Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial
  • Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit
  • Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (CYP3A4/5) within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2)
  • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >3X the upper limit of normal (ULN) at screening visit (Visit 1)
  • Clinically significant laboratory abnormalities or medical conditions which pose a safety risk for the participant or may interfere with the trial objectives in the investigator's opinion (except for renal function tests or deviation of clinical laboratory values that are related to the podocytopathy in question) at screening visit
  • QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator's discretion) at screening visit (Visit 1) Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo cohort
Drug: Placebo matching BI 764198
Placebo matching BI 764198
Experimental: Secondary focal segmental glomerulosclerosis (sFSGS) cohort
Drug: BI 764198
BI 764198
Other Names:
  • Apecotrep
Experimental: Treatment resistant primary Minimal Change Disease (TR-pMCD) cohort
Drug: BI 764198
BI 764198
Other Names:
  • Apecotrep
Experimental: Alport Syndrome cohort
Drug: BI 764198
BI 764198
Other Names:
  • Apecotrep
Experimental: Treatment resistant primary Membranous Nephropathy (TR-pMN) cohort
Drug: BI 764198
BI 764198
Other Names:
  • Apecotrep

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relative change from baseline to Week 20 in 24-hr Urine protein-to-Creatinine Ratio (UPCR)
Time Frame: At baseline and week 20
At baseline and week 20

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment response, defined as at least 25% relative reduction in 24-hr UPCR from baseline to Week 20
Time Frame: At baseline and week 20
At baseline and week 20
Treatment response, defined as at least 40% relative reduction in 24-hr UPCR from baseline to Week 20
Time Frame: At baseline and week 20
At baseline and week 20
Absolute change in estimated glomerular filtration rate (eGFR) in mL/min/1.73m2 (based on cystatin C) from baseline to Week 20
Time Frame: At baseline and week 20
At baseline and week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2026

Primary Completion (Estimated)

January 20, 2028

Study Completion (Estimated)

February 17, 2028

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 1434-0027
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523425-17 (Registry Identifier: CTIS)
  • U1111-1328-7108 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'.

For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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