Last updated 14 days ago
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
286 patients around the world
Available in Argentina, United States, Mexico, Brazil
Boehringer Ingelheim
10Research sites
286Patients around the world
This study is for people with
Glomerulonephritis
Focal segmental glomerulosclerosis
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- Male or female participants ≥12 years old on the day of signing informed consent/assent.Weight of ≥40 kg at the screening visit.Body mass index (BMI) of ≤40 kg/m² at the screening visit.Participants with a diagnosis prior to the screening visit of either.Biopsy-confirmed primary focal segmental glomerulosclerosis (pFSGS) based on Investigator's judgement.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 urine sample both assessed by central laboratory at the screening visit.Estimated glomerular filtration rate (eGFR).For adult participants (≥18 years): ≥25 mL/min/1.73 m² based on chronic kidney disease epidemiology collaboration (CKD-EPI) formula based on combined serum creatinine plus cystatin C at the screening visit.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.
- Known monogenic or syndromic causes of FSGS with the exception of TRPC6 gain-of-function gene mutations.Clinical or histologic evidence of secondary maladaptive or toxic forms of FSGS based on Investigator's judgement.FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit 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 in the last 6 months prior to screening.
Sites
Centro Médico Maffei - CABA, Buenos Aires
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Hospital Universitario Austral - Pilar
CardioAlem Investigaciones
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Clínica Privada Vélez Sarsfield - Córdoba
Hospital de Clínicas de Porto Alegre
Hospital das Clínicas Universidade Federal de Pernambuco - UFPE
Hospital do Rim - HRIM– Fundação Oswaldo Ramos
Instituto Nacional de Cardiologia Ignacio Chavez
SponsorBoehringer Ingelheim
Study typeInterventional
Conditions
Focal segmental glomerulosclerosis
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07220083
