2024-511706-23-00已完成2 期
A multicenter, randomized, double-blind, parallel group, placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics profile of BI 764198 administered orally once daily for 12 weeks in patients with focal segmental glomerulosclerosis.
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 20
- 主要终点
- Number of patients achieving at least 25% reduction in 24-hour urine protein-creatinine ratio (UPCR) relative to baseline at week 12
研究概览
简要总结
To explore the efficacy of BI 764198 in lowering proteinuria
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent in accordance with ICH-GCP and local legislation prior to admission to the study.
- •Male and female patients 18 years to 75 years (both inclusive) of age on the day of signing informed consent.
- •Patients diagnosed with biopsy proven primary focal segmental glomerulosclerosis (FSGS) or documented transient receptor potential cation subfamily C member 6 (TRPC6) gene mutation causing FSGS prior to screening visit.
- •Urine protein-creatinine ratio (UPCR) ≥ 1000 mg/g based on first morning void urine sample during screening.
- •Patients treated with corticosteroids must be on a stable dose for at least 4 weeks prior to screening visit with no plan to change the dose until end of trial treatment.
- •Patients treated with angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), finerenone, aldosterone inhibitors, or sodium-glucose cotransporter-2 (SGLT2) inhibitors should be on a stable dose for at least 4 weeks prior to screening visit with no plan to change the dose until end of trial treatment.
- •Body Mass Index (BMI) of ≤ 40 kg/m2 at screening visit.
- •Women of childbearing potential (WOCBP) must be willing and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the informed consent form (ICF).
排除标准
- •Known monogenic (with the exception of TRPC6 gene mutations) or clinical or histologic evidence of secondary FSGS.
- •Documented Alport syndrome, Nail Patella syndrome, diabetic nephropathy, IgA-nephropathy, lupus nephritis, or monoclonal gammopathy (e.g., multiple myeloma).
- •Genito-urinary malformations with vesicoureteral reflux or renal dysplasia.
- •A history of organ transplantation or planned transplantation during the course of the study.
- •Uncontrolled hypertension defined as an average resting systolic blood pressure >160 mmHg calculated from the last two of the triplicate sitting blood pressure measurements at screening visit. Patients with a documented history of white coat hypertension may be included.
- •Concomitant use of calcineurin inhibitors within 5 half-lives before screening visit.
- •Concomitant treatment with cytotoxic agents (cyclophosphamide, chlorambucil), or CD20 monoclonal antibody, e.g., rituximab, within 5 half-lives before screening visit.
- •Treatment with metformin or dofetilide (multidrug and toxin extrusion 1 (MATE1) or organic cation transporter 2 (OCT2) substrates); dabigatran or digoxin (P-gp substrates with narrow therapeutic window) within 5 half-lives before screening visit.
- •Further exclusion criteria apply.
结局指标
主要结局
Number of patients achieving at least 25% reduction in 24-hour urine protein-creatinine ratio (UPCR) relative to baseline at week 12
Number of patients achieving at least 25% reduction in 24-hour urine protein-creatinine ratio (UPCR) relative to baseline at week 12
次要结局
- Change in 24-hour UPCR relative to visit 3 at week 12
- Change in 24-hour UPCR relative to baseline at week 13
- Change in 24-hour urinary protein excretion relative to baseline at week 12
- Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 4
- Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 12
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (20)
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