Clinical Trials List
2025-11-01 - 2030-12-31
Phase III
Recruiting6
ICD-10N03.1
Chronic nephritic syndrome with focal and segmental glomerular lesions
ICD-10N03.3
Chronic nephritic syndrome with diffuse mesangial proliferative glomerulonephritis
ICD-9582.1
Chronic glomerulonephritis, with lesion of membranous glomerulonephritis
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial to Assess the Effects of Oral TRPC6 Inhibitor BI 764198 Taken Over a 104 Week Treatment Period in Adult and Adolescent Participants With Primary Focal Segmental Glomerulosclerosis (pFSGS) or Genetic FSGS Related to TRPC6 Gene Variants
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Trial Applicant
Boehringer Ingelheim
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/04/09
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 謝易庭 Division of Ophthalmology
- 黃道民 Division of General Internal Medicine
- CHUN-FU LAI Division of General Internal Medicine
- 楊紹佑 Division of General Internal Medicine
- WEN-CHIH CHIANG Division of General Internal Medicine
- 潘思宇 Division of Family Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 蔡尚峰 Division of Nephrology
- LIN-SHIEN Fu Division of Pediatrics
- CHENG-HSU CHEN Division of Nephrology
- TUNG-MIN YU Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 賴史忠 Division of Ophthalmology
- YUNG-HO HSU
- Li-Yee Hong
- Mei-Yi Wu
- Chia-Te Liao
- Cai-Mei Zheng
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Placebo to BI 764198 Film-coated Tablets
Dosage Form
116
Dosage
Endpoints
Inclution 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 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 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
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 (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.
The Estimated Number of Participants
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Taiwan
12 participants
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Global
286 participants
