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Recruiting Phase 3 NCT07220083

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

Phase 3 – large-scale trial before approval
Conditions: Focal Segmental Glomerulosclerosis

Sponsor: Boehringer Ingelheim

trial.available_in: БГ
Overview
This study is open to adults and adolescents with a kidney condition called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 helps people with FSGS. Participants are put into 2 groups randomly, which means by chance. Every participant has an equal chance of being in each group. 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 up to 2 years. All participants also continue their standard medication for FSGS. Participants are in the study for up to 2 years. During this time, they visit the study site about every 3 months. Participants regularly collect urine samples. This is done to check their kidneys. 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.
Who can participate
Inclusion criteria: 1. Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1) 2. Weight of ≥40 kg at the screening visit (Visit 1) 3. Body mass index (BMI) of ≤40 kg/m² at the screening visit (Visit 1) 4. 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) 5. Urine protein-creatinine ratio (UPCR) ≥1500 mg/g based on the mean of the spot urine sample and first morning void urine sample (both assessed by central laboratory) at the screening visit (Visit 1) 6. 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 combined serum creatinine plus 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 height and serum cystatin C at the screening visit (Visit 1) Further inclusion criteria apply. Exclusion criteria: 1. Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations) 2. Clinical or histologic evidence of secondary maladaptive or toxic forms of FSGS (based on Investigator's judgement) 3. FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement) 4. A history of organ transplantation or planned organ transplantation during the course of the trial 5. Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1) Further exclusion criteria apply.
Locations 32
Argentina (1)
Terapia Renal Domiciliaria
Buenos Aires
NOT_YET_RECRUITING
Australia (1)
Nepean Hospital
Kingswood , New South Wales
NOT_YET_RECRUITING
Belgium (1)
AZORG Ziekenhuis
Aalst
NOT_YET_RECRUITING
Brazil (1)
Synvia
Campinas
NOT_YET_RECRUITING
Canada (1)
Victoria Hospital (LHSC)
London , Ontario
NOT_YET_RECRUITING
China (1)
The First Affiliated Hospital of Baotou Medical College
Baotou
NOT_YET_RECRUITING
Croatia (1)
Clinical Hospital Sveti Duh
Zagreb
NOT_YET_RECRUITING
Denmark (1)
Copenhagen University Hospital, Rigshospitalet
København Ø
NOT_YET_RECRUITING
France (1)
CHU Amiens-Picardie
Amiens
NOT_YET_RECRUITING
Georgia (1)
LTD Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi
NOT_YET_RECRUITING
Greece (1)
University General Hospital of Heraklion
Heraklion
NOT_YET_RECRUITING
Hong Kong (1)
Hong Kong Children's Hospital
Hong Kong
NOT_YET_RECRUITING
India (1)
Aartham Multi Super Speciality Hospital
Ahmedabad
NOT_YET_RECRUITING
Italy (1)
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Bari
NOT_YET_RECRUITING
Japan (1)
Kasugai Municipal Hospital
Aichi, Kasugai
NOT_YET_RECRUITING
Malaysia (1)
Hospital Sultan Idris Shah Serdang
Kajang
NOT_YET_RECRUITING
Mexico (1)
Centenario Hospital Miguel Hidalgo
Aguascalientes
NOT_YET_RECRUITING
Netherlands (1)
Amsterdam UMC Locatie AMC
Amsterdam
NOT_YET_RECRUITING
New Zealand (1)
Waikato Hospital
Hamilton , Waikato Region
NOT_YET_RECRUITING
Norway (1)
Akershus Universitetssykehus HF
Lørenskog
NOT_YET_RECRUITING
Philippines (1)
Manila Doctors Hospital
Manila
NOT_YET_RECRUITING
Poland (1)
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz
NOT_YET_RECRUITING
Romania (1)
Institutul Clinic Fundeni
Bucharest
NOT_YET_RECRUITING
Singapore (1)
National University Hospital
Singapore
NOT_YET_RECRUITING
Slovakia (1)
Faculty hospital with clinics F.D. Roosevelta
Banská Bystrica
NOT_YET_RECRUITING
South Korea (1)
Pusan National University Hospital
Busan
NOT_YET_RECRUITING
Spain (1)
Complejo Hospitalario Torrecárdenas
Almería
NOT_YET_RECRUITING
Sweden (1)
Danderyds Sjukhus
Danderyd
NOT_YET_RECRUITING
Taiwan (1)
Buddhist Tzu Chi General Hospital-Hualien-20741
Hualien City
NOT_YET_RECRUITING
Turkey (1)
Adana City Hospital
Adana
NOT_YET_RECRUITING
United Kingdom (1)
Clatterbridge Hospital
Bebington
NOT_YET_RECRUITING
United States (1)
Alabama Kidney Research
Alabaster , Alabama
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Healthy volunteers
No
Start date
16.02.2026
Completion date
18.12.2029
Registry ID
NCT07220083
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.