A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS) | NCT07220083 | Trialant

A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS) | NCT07220083 | Trialant

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion criteria:

Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1)

Weight of ≥40 kg at the screening visit (Visit 1)

Body mass index (BMI) of ≤40 kg/m² at the screening visit (Visit 1)

Participants with a diagnosis prior to the screening visit (Visit 1) of either:

Biopsy-confirmed primary focal segmental glomerulosclerosis (pFSGS) (based on Investigator's judgement) OR

Genetic focal segmental glomerulosclerosis (FSGS) resulting from a gain-of-function mutation in the transient receptor potential cation subfamily C member 6 (TRPC6) gene (based on historical genetic test)

Urine protein-creatinine ratio (UPCR) ≥1500 mg/g based on the mean of the spot urine sample and first morning void (FMV) urine sample (both assessed by central laboratory) at the screening visit (Visit 1)

Estimated glomerular filtration rate (eGFR)

For adult participants (≥18 years): ≥25 mL/min/1.73 m² (chronic kidney disease epidemiology collaboration (CKD-EPI) formula based on serum cystatin C) at the screening visit (Visit 1)

For adolescent participants (12 to <18 years): ≥25 mL/min/1.73 m² based on chronic kidney disease under 25 years (CKiD U25) formula using serum cystatin C at the screening visit (Visit 1) Further inclusion criteria apply.

Exclusion criteria:

Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)

Clinical or histologic evidence of secondary adaptive or toxic forms of FSGS (based on Investigator's judgement)

FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement)

A history of organ transplantation or planned organ transplantation during the course of the trial

Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1) Further exclusion criteria apply.

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Hospital Universitario Virgen de las NievesRecruiting

Granada, 18014, Spain

Hospital Universitario 12 de OctubreRecruiting

Madrid, 28041, Spain

Universitetssjukhuset LinköpingRecruiting

Linköping, 581 85, Sweden

Skånes universitetssjukhusRecruiting

Lund, 221 85, Sweden

Karolinska UniversitetssjukhusetNot yet recruiting

Stockholm, 141 86, Sweden

Danderyds SjukhusRecruiting

Stockholm, 182 88, Sweden

Uppsala University HospitalRecruiting

Uppsala, 751 85, Sweden

University Hospital BernNot yet recruiting

Bern, 3010, Switzerland

University Hospital ZurichNot yet recruiting

Zurich, 8091, Switzerland

Buddhist Tzu Chi General Hospital-Hualien-20741Recruiting

Hualien City, 970, Taiwan

Kaohsiung Chang Gung Memorial HospitalRecruiting

Kaohsiung City, 83301, Taiwan

Far Eastern Memorial HospitalRecruiting

New Taipei City, 220, Taiwan

Taipei Medical University-Shuang Ho HospitalRecruiting

New Taipei City, 235, Taiwan

China Medical University HospitalRecruiting

Taichung, 40447, Taiwan

Taichung Veterans General HospitalRecruiting

Taichung, 40705, Taiwan

National Cheng Kung University HospitalRecruiting

Tainan, 70403, Taiwan

National Taiwan University HospitalRecruiting

Taipei, 10048, Taiwan

Chang Gung Memorial Hospital, LinkouRecruiting

Taoyuan City, 333, Taiwan

King Chulalongkorn Memorial HospitalNot yet recruiting

Bangkok, 10330, Thailand

Maharaj Nakom Chiangmai HospitalRecruiting

Chiang Mai, 50200, Thailand

Adana City HospitalNot yet recruiting

Adana, 01220, Turkey (Türkiye)

Ankara Etlik City HospitalNot yet recruiting

Ankara, 06200, Turkey (Türkiye)

Malatya Inonu University HospitalNot yet recruiting

Battalgazi / Malatya, 44280, Turkey (Türkiye)

Boehringer IngelheimContact

turkiye@bitrialsupport.com08006212470

Bursa Uludag UniversityRecruiting

Bursa, 16110, Turkey (Türkiye)

Istanbul Capa UniversityRecruiting

Istanbul, 34093, Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip FakultesiNot yet recruiting

Istanbul, 34098, Turkey (Türkiye)

Kocaeli University Faculty of Medicine HospitalRecruiting

İzmit, 41000, Turkey (Türkiye)

Erciyes UniversityRecruiting

Melikgazi/Kayseri, 38039, Turkey (Türkiye)

Boehringer IngelheimContact

turkiye@bitrialsupport.com08006212470

Afyon Kocatepe University HospitalNot yet recruiting

Merkez / Afyonkarahisar, 03100, Turkey (Türkiye)

Boehringer IngelheimContact

turkiye@bitrialsupport.com08006212470

Mersin University Medical FacultyNot yet recruiting

Mersin, 33110, Turkey (Türkiye)

Sakarya Üniversitesi Tıp FakültesiNot yet recruiting

Sakarya, 54187, Turkey (Türkiye)

Clatterbridge HospitalRecruiting

Bebington, CH63 4JY, United Kingdom

Bradford Institute for Health ResearchRecruiting

Bradford, BD9 6RJ, United Kingdom

Addenbrooke's HospitalRecruiting

Cambridge, CB2 0QQ, United Kingdom

Leicester General HospitalNot yet recruiting

Leicester, LE5 4PW, United Kingdom

Royal Free HospitalNot yet recruiting

London, NW3 2QG, United Kingdom

King's College HospitalRecruiting

London, SE5 9RS, United Kingdom

Salford RoyalRecruiting

Salford, M6 8HD, United Kingdom