2025-522191-86-00招募中3 期
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
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.93 个研究点 分布在 12 个国家目标入组 86 人开始时间: 2025年12月5日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 93
- 主要终点
- Relative change in 24-hour UPCR, (measured in mg/g) from baseline to Week 104
研究概览
简要总结
The primary objective is to demonstrate superiority of BI 764198 for the mean relative change from baseline to Week 104 in 24-hour urinary protein-to-creatinine ratio (UPCR, measured in mg/g) in participants with pFSGS or those with genetic FSGS due to TRPC6 gain-of-function gene mutations, some of whom are on background calcineurin inhibitor (CNI) treatment.
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 18-64 Years, 0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •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 pFSGS (based on Investigator’s judgement) OR - genetic FSGS resulting from a gain-of-function gene mutation in the TRPC6 gene (based on historical genetic test)
- •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): ≥25 mL/min/1.73 m2 (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 CKiD U25 formula using serum cystatin C at the screening visit (Visit 1)
- •Further inclusion criteria apply.
排除标准
- •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.
研究组 & 干预措施
Placebo matching BI 764198
Placebo
干预措施: Placebo matching BI 764198 (Drug)
BI 764198
Test
干预措施: BI 764198 (Drug)
结局指标
主要结局
Relative change in 24-hour UPCR, (measured in mg/g) from baseline to Week 104
Relative change in 24-hour UPCR, (measured in mg/g) from baseline to Week 104
Relative change in 24-hour urinary protein-to-creatinine ratio (UPCR, measured in mg/g) from baseline to Week 104
Relative change in 24-hour urinary protein-to-creatinine ratio (UPCR, measured in mg/g) from baseline to Week 104
次要结局
- Change from baseline across disease-specific Clinical Outcome Assessment (COA) NS-SIM-PRO at Week 104
- Change from baseline across COA KDQOL-36 at Week 104
- Key secondary endpoint: Absolute change in eGFRcys in mL/min/1.73m2 from baseline to Week 104
- Key secondary endpoint: Treatment response, defined as 24-hr UPCR <1000 mg/g at Week 104
- Treatment response, defined as 24-hr UPCR <1000 mg/g and eGFRcys ≥85% vs. baseline at Week 104 and no treatment failure between randomisation and Week 104 (combined or multi-component endpoint)
- Complete remission, defined as 24-hr UPCR <300 mg/g at Week 104
- Change from baseline across disease-specific COA NS-SIM-PRO at Week 104
- Change from baseline across Clinical Outcome Assessment (COA) KDQOL-36 at Week 104
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (93)
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