PODOMOUNT-Basket, a Phase II, Multicentre, Randomised, 2-arm Parallel-group, Double-blind, Placebo-controlled Basket Trial to Assess Safety, Tolerability, PK, and Efficacy of BI 764198 in Four Proteinuric Kidney Diseases

This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions.
Participants are put into 2 groups randomly, which means by chance. 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 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group.
Participants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. 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.

开始日期2026-02-24

申办/合作机构

Boehringer Ingelheim GmbH

NCT07308652

/ Not yet recruiting临床1期

The Effect of Multiple Doses of Itraconazole on the Single-dose Pharmacokinetics of BI 764198 Following Oral Administration in Healthy Male Trial Participants (an Open-label, Non-randomised, Two-period, Fixed-sequence Design Study)

The purpose of this study is to find out whether a medicine called itraconazole changes the amount of another medicine called BI 764198 in the blood. Some people may take more than 1 medicine at a time. Therefore, it is important to understand how medicines influence each other. This study will help us learn more about how BI 764198 works.

开始日期2026-02-09

申办/合作机构

Boehringer Ingelheim GmbH

NCT07220083

/ Not yet recruiting临床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

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.

开始日期2026-02-06

申办/合作机构

Boehringer Ingelheim GmbH

100 项与 Apecotrep 相关的临床结果

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100 项与 Apecotrep 相关的转化医学

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100 项与 Apecotrep 相关的专利（医药）

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项与 Apecotrep 相关的文献（医药）

2026-01-01·LANCET

TRPC6 inhibition for the treatment of focal segmental glomerulosclerosis: a randomised, placebo-controlled, phase 2 trial of BI 764198

Article

作者: Kretzler, Matthias ; Prasad, Srinivasa ; Cross, Nicholas ; Gesualdo, Loreto ; Licarião Rocha, Fabia T ; Retlich, Silke ; Trachtman, Howard ; Kaufeld, Jessica ; Ye, Zhiming ; Meijers, Björn ; Lobmeyer, Maximilian T ; Chen, Qinkai ; Derebail, Vimal K ; Soleymanlou, Nima ; Ng, Monica Suet Ying ; Ji, Bo ; Workeneh, Biruh

BACKGROUND:

In focal segmental glomerulosclerosis (FSGS), transient receptor potential cation channel, subfamily C, member 6 (TRPC6) overactivity might cause podocyte loss and progressive kidney function decline. This exploratory study assessed the safety and efficacy of a novel once-daily oral selective TRPC6 inhibitor, BI 764198.

METHODS:

This multicentre phase 2, double-blind, placebo-controlled, randomised controlled trial assessed BI 764198 (20 mg, 40 mg, or 80 mg once daily) versus placebo over 12 weeks in participants aged 18-75 years with biopsy-confirmed primary FSGS (based on the absence of clinical evidence of secondary cause) or with a disease-causing TRPC6 variant. The study took place in 31 sites in ten countries, and random allocation was performed centrally in blocks in a 1:1:1:1 ratio and was stratified according to use of corticosteroids. Participants were receiving stable conservative and immunosuppressive therapy, with screening urine protein-creatinine ratio (UPCR) at 1·0 g/g or greater and estimated glomerular filtration rate at 30 mL/min per 1·73 m² or greater. The primary endpoint was the proportion of participants with proteinuria response (≥25% UPCR reduction from baseline) at week 12. Other key outcomes were safety and tolerability. The study was registered with ClinicalTrials.gov on Jan 27, 2022 (NCT05213624) and is complete as of Jan 3, 2025.

FINDINGS:

From March 10, 2022, to Sept 3, 2024, 139 participants were screened and 67 were randomly assigned to receive placebo or BI 764198 at doses of 20 mg, 40 mg, or 80 mg (five participants were randomly assigned in error and were not treated). 62 participants received treatment, two of whom had missing baseline or post-baseline UPCR measurements and were not included in the full analysis set. Overall, 37 participants (60%) were male and 25 participants (40%) were female; the mean age was 40·7 years (SD 12·6); and the majority of the trial cohort were White (39 [63%] of 62). Proteinuria responses were observed in eight (44%) of 18, two (14%) of 14, and six (43%) of 14 participants receiving BI 764198 20 mg, 40 mg, and 80 mg, respectively (16 [35%] of 46 for all BI 764198 doses) versus one (7%) of 14 receiving placebo; corresponding odds ratios (ORs) versus placebo were OR 10·0 (95% CI 1·6-118·1), 1·5 (0·2-19·5), and 6·0 (0·9-73·6) for the three doses of BI 764198, and 4·9 (1·0-48·8) for all doses combined. BI 764198 was well tolerated with no meaningful differences in adverse event frequencies across treatment arms; treatment-emergent adverse events were reported by 44 (71%) of 62 participants, with similar frequencies of adverse events observed in the placebo group (ten [71%] of 14) and BI 764198 groups (34 [71%] of 48).

INTERPRETATION:

BI 764198 lowered proteinuria and was well tolerated by participants in this trial. This is the first evidence of efficacy with a podocyte-targeted therapy in FSGS. Larger randomised controlled trials over longer treatment durations, enabling meaningful subgroup analyses, are planned to evaluate the safety and efficacy of BI 764198 treatment in FSGS and other conditions affected by podocytopathy.

FUNDING:

Boehringer Ingelheim.

2025-05-04·EXPERT OPINION ON INVESTIGATIONAL DRUGS

Phase 1 trials of BI 764198, a transient receptor potential channel 6 inhibitor, in healthy volunteers and participants with kidney impairment

Article

作者: Soleymanlou, Nima ; Seitz, Friedeborg ; Wülfrath, Hauke S. ; Lobmeyer, Maximilian T. ; Schultz, Armin ; Halabi, Atef ; Retlich, Silke ; Lemmens, Katrien ; Choi, Wansuk

BACKGROUND:

BI 764198 could reduce podocyte injury in focal segmental glomerulosclerosis (FSGS).

RESEARCH DESIGN AND METHODS:

Four Phase 1 BI 764198 trials: single rising dose (SRD) and multiple rising dose (MRD)/drug-drug interaction trials in healthy volunteers; relative bioavailability (rBA) study (food and formulations effects on pharmacokinetics; PK); and kidney impairment (KI) PK study.

RESULTS:

SRD trial: 4/54 BI 764198-treated participants (7.4%) had ≥ 1 investigator-defined drug-related adverse event (DRAE): headache (n = 3; 5.6%); diarrhea (n = 1; 16.7%). BI 764198 PK was approximately linear. MRD trial: DRAEs occurred in 5/32 (15.6%) participants receiving BI 764198 and 1/8 (12.5%) receiving placebo. Once-daily BI 764198 80 mg (10 days) did not alter midazolam PK. All BI 764198 formulations tested had similar rBA; food did not affect PK. KI study: geometric mean ratios for area under the plasma concentration-time curve were 147.8% and 177.7% for participants with moderate and severe KI, respectively (vs. without). Limitations include typically small Phase 1 sample sizes and open-label design for the rBA and KI trials.

CONCLUSIONS:

BI 764198 was well tolerated and could be taken with/without food; evaluation in FSGS is ongoing.

CLINICAL TRIAL REGISTRATION:

The trials are registered at www.clinicaltrials.gov with codes NCT03854552; NCT04102462; NCT04656288; NCT04176536.

2025-05-04·EXPERT OPINION ON INVESTIGATIONAL DRUGS

A randomized, Phase I study of the safety, tolerability, and pharmacokinetics of BI 764198, a transient receptor potential channel 6 (TRPC6) inhibitor, in healthy Japanese men

Article

作者: Tachibana, Yoshifumi ; Retlich, Silke ; Soleymanlou, Nima ; Sarashina, Akiko ; Yonemura, Takuma

BACKGROUND:

BI 764198 is a selective, oral transient receptor potential cation channel, subfamily C, member 6 inhibitor under investigation for focal segmental glomerulosclerosis.

RESEARCH DESIGN AND METHODS:

Phase I study in 44 Japanese male volunteers. Single dose part: BI 764198 20 mg (n = 6) vs. placebo (n = 2); multiple dose part: BI 764198 40, 80, or 160 mg (n = 9 each) or placebo (n = 9) as a single dose then multiple daily dosing for 2 weeks. Primary endpoint: participants with drug-related adverse events (DRAEs); secondary endpoints: pharmacokinetic.

RESULTS:

DRAEs were reported in 20.5% (9/44) of participants (total BI 764198 21.2% [7/33]; placebo 18.2% [2/11]), mostly diarrhea (total BI 764198 15.2% [5/33]; placebo 18.2% [2/11]) and headache (BI 764198 80 mg 11.1% [1/9]; BI 764198 160 mg 33.3% [3/9]). BI 764198 exposure increased near dose proportionally to 80 mg and was slightly higher than anticipated with 160 mg. Pharmacokinetics were similar in Asians and non-Asians after accounting for body weight. Limitations include small sample size per dose and short trial duration.

CONCLUSIONS:

BI 764198 was well tolerated; exposure increased near dose proportionally to 80 mg, as previously observed in predominantly White volunteers.

CLINICAL TRIAL REGISTRATION:

This study was registered on Clinical Trials.gov, identifier NCT04665700.

项与 Apecotrep 相关的新闻（医药）

2026-02-04

·美通社

勃林格殷格翰在研药物apecotrep在II期肾病试验中实现蛋白尿降低

Apecotrep（BI 764198）是一款潜在的同类首创、口服、选择性TRPC6 抑制剂，作为一种新型、靶向、非免疫抑制类疗法，用于治疗原发性局灶节段性肾小球硬化（FSGS）的研究正在进行中。原发性FSGS是一种罕见的肾脏疾病，肾脏滤过屏障的重要组成部分足细胞的受损与丢失，会逐渐导致蛋白尿并发展为肾衰竭。发表在《柳叶刀》上的II期临床试验结果显示，接受apecotrep（20mg剂量组）治疗12周后，患者的蛋白尿较安慰剂组降低了40%。目前III期临床试验正在招募原发性FSGS的成人及青少年患者。另一项针对其他蛋白尿性肾病的II期临床试验将于今年第一季度启动。上海 2026年2月4日 /美通社/ -- 近日，勃林格殷格翰公布了一项为期12周的II期临床试验结果，该试验评估了apecotrep（BI 764198）的疗效和安全性。Apecotrep是一款口服、潜在同类首创、非免疫抑制性的TRPC6 抑制剂，用于治疗原发性局灶节段性肾小球硬化（FSGS）。蛋白尿是反映肾脏损伤的关键指标，相比安慰剂，接受20 mg剂量apecotrep治疗的患者组的蛋白尿降低了40%。 [1] 该研究成果已发表于《柳叶刀》，并在2025年美国肾脏病学会（ASN）肾脏周大会上报告。III期临床试验（NCT07220083）目前正在招募原发性FSGS的成人及青少年患者。此外，另一项评估apecotrep在其他蛋白尿性肾病中安全性和疗效的II期临床试验（NCT07355296）将于今年第一季度启动。 Apecotrep展现了勃林格殷格翰致力于解决广泛肾病领域高度未满足的医疗需求的承诺，其中也包括目前仍无获批疾病修饰疗法的原发性肾脏疾病。 "这些结果突显了勃林格在肾脏健康领域的科学领导力，以及我们对患有心血管-肾脏-代谢疾病患者（包括原发性FSGS等罕见肾病患者）的承诺。"勃林格殷格翰董事会成员创新事业部负责人Paola Casarosa表示，"随着III期临床试验的推进，我们正在加速推动apecotrep的研发，使其有望成为首个用于原发性FSGS的疾病修饰疗法，重新定义患者的标准治疗。" 原发性FSGS是一种罕见且具进展性的肾病，最终可发展成肾衰竭。 [ 2,3,4 ] 尽管疾病严重且给患者带来沉重负担，目前仍尚无获批的靶向疗法。 [ 5,6,7 ] 能够从疾病根本机制入手的靶向疗法仍存在巨大的未被满足医疗需求。 "原发性FSGS是一种严重的肾小球疾病，也是儿童和成人肾衰竭的重要原因之一。通过靶向原发性FSGS的潜在致病机制，apecotrep在成人患者中实现了较安慰剂40%的蛋白尿降低，且具有良好的耐受性。"密歇根大学首席研究者Howard Trachtman说，"这些具有临床意义的研究结果强化了进一步研究apecotrep作为原发性FSGS潜在同类首创靶向疗法的必要性，这一疾病领域仍存在高度未满足的医疗需求。" 在原发性FSGS中，足细胞（负责肾脏滤过功能的细胞）上的瞬时受体电位通道6（TRPC6）被认为处于过度激活状态。 [8] 这种过度激活会导致过量钙离子进入细胞，引起足细胞的持续损伤和丢失，最终导致蛋白尿并推动肾脏疾病进展。Apecotrep旨在通过降低蛋白尿来保护足细胞，从而减缓疾病进程。 [ 9 ] 鉴于其作为原发性FSGS治疗新选择的潜力，apecotrep已获得中国国家药品监督管理局药审中心（CDE）授予的突破性疗法认定，并获得欧洲药品管理局（EMA）和日本厚生劳动省（MHLW）授予的孤儿药资格认定。关于 apecotrep（BI 764198）及II期试验 Apecotrep（BI 764198）是一款在研的、潜在同类首创、每日一次口服、非免疫抑制性的TRPC6抑制剂，正在开发用于治疗原发性FSGS。 [ 9] 其作用机制旨在对抗TRPC6的过度激活 —— TRPC6是维持足细胞结构和功能的重要离子通道，而足细胞是负责肾脏滤过功能的细胞。 [ 9] 该化合物由勃林格殷格翰研发，是公司心血管-肾脏-代谢（CRM）产品组合的一部分。 II期临床试验中，将尿蛋白/肌酐比（UPCR）降低≥25%定义为治疗应答。经过12周治疗后，所有剂量组中共有35%的apecotrep受试者达到该应答标准，而安慰剂组仅为14人中的1人（7.1%）达到该标准。其中，20 mg剂量组的患者响应比例最高（达到44.4%）。此外，20 mg剂量组相比安慰剂组实现了40%的UPCR降幅（p=0.0024）。总体来看，apecotrep的整体耐受性良好。关于原发性局灶节段性肾小球硬化原发性局灶节段性肾小球硬化（FSGS）是一类足细胞病，其特征为足细胞受损和丢失导致尿液中蛋白质异常升高（蛋白尿）。大约50%的原发性FSGS患者会在5–10年内进展为终末期肾病（ESKD）。 [ 10 ] FSGS是成年人肾病综合征的主要病因之一，全球估计发病率约为每10万人口0.8人。 [ 7] 该疾病与肾小球（肾脏滤过单位）瘢痕形成相关，可引起下肢和身体其他部位水肿、泡沫尿、疲劳、体重增加、高血压和胆固醇升高。 [ 11 ] 原发性FSGS指疾病在无明确诱因的情况下发生，而继发性FSGS则由感染、糖尿病或肥胖等可识别原因引起。 [11] 此外，遗传性FSGS是由足细胞或肾小球基底膜蛋白的基因突变或某些易感基因（如TRPC6）导致。 [ 12,13] References 1. Trachtman H, et al. TRPC6 inhibition for the treatment of focal segmental glomerulosclerosis: a randomized, placebo-controlled, phase 2 trial of BI 764198. Lancet. 2026;S0140-6736(25)02255-X. 2. Rosenberg AZ, Kopp JB. Focal segmental glomerulosclerosis. Clinical Journal of the American Society of Nephrology. 2017;12:502–517. 3. Munis MA, et al. Incidence and proportion of primary focal segmental glomerulosclerosis (FSGS) among a racially and ethnically diverse adult patient population between 2010 and 2021. Clinical Journal of the American Society of Nephrology. 2025;20(2):229-238. 4. Ossareh S, et al. Kidney outcome in primary focal segmental glomerulosclerosis (FSGS) by using a predictive model. Iranian Journal of Kidney Diseases. 2021;15(6):408-418. 5. Buttgereit F, et al. Optimised glucocorticoid therapy: the sharpening of an old spear. Lancet 2005;365:801–803. 6. Trachtman H. Emerging drugs for treatment of focal segmental glomerulosclerosis. Expert Opinion on Emerging Drugs. 2020;25(3):367-375. 7. McGrogan A, et al. The incidence of primary glomerulonephritis worldwide: a systematic review of the literature. Nephrology Dialysis Transplantation. 2011;26(2):414-30. 8. Kim EY, et al. Changes in podocyte TRPC channels evoked by plasma and sera from patients with recurrent FSGS and by putative glomerular permeability factors. Molecular Basis of Disease. 2017;1863(9):2342-2354. 9. Trachtman H, et al. TRPC6 inhibitor BI 764198 in focal segmental glomerulosclerosis: Phase 2 study design. Kidney International Reports. 2023;;8(12):2822-2825. 10. Bensink ME, et al. Kidney failure attributed to focal segmental glomerulosclerosis: a USRDS retrospective cohort study of epidemiology, treatment modalities, and economic burden. Kidney Medicine. 2023;6(2):100760. 11. Mayo Clinic. Focal segmental glomerulosclerosis (FSGS). Available at: https://www.mayoclinic.org/diseases-conditions/fsgs/symptoms-causes/syc-20354693 . Accessed January 2026. 12. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney International. 2021;100:S1-S276. 13. Winn MP et al. A mutation in the TRPC6 cation channel causes familial focal segmental glomerulosclerosis. Science. 2005;308(5729):1801-4.

临床2期临床3期临床结果引进/卖出

2026-02-02

·今日头条

全球肾脏病周报：（1.27-2.2）

产业与器械重磅 (Industry & Devices) 1. Outset Medical 新一代 Tablo 透析系统获 FDA 510(k) 批准【器械创新】 1月27日，Outset Medical 宣布其新一代 Tablo® 血液透析系统获得 FDA 510(k) 许可。核心亮点：此次获批使 Tablo 成为首个符合 FDA 2025年最新、最严苛网络安全（Cybersecurity）指南的透析设备。临床意义：新系统不仅在硬件耐用性上进行了升级以适应医院急症环境，更在数据传输安全性上建立了新行业标准，计划于2026年第二季度正式向客户发货。信息来源： Outset Medical Official Press Release / GlobeNewswire 2. Quanta 透析系统扩展急重症应用，播客披露最新战略【重症肾脏病】 1月29日，在最新的医疗制造行业播客中，Quanta Dialysis Technologies 披露了其便携式透析系统在急重症护理（Critical Care）领域的最新部署进展。进展：基于其 FDA 获批的连续性肾脏替代治疗（CRRT）功能，Quanta 正通过与 Innovative Renal Care 的战略合作，加速在 ICU 场景下的应用，旨在解决传统大型 CRRT 设备操作复杂的问题。信息来源： Medical Design & Development / Quanta News 3. Monogram Health 高管入选纳什维尔医疗委员会，强化居家肾病护理话语权【行业动态】 1月27日消息，居家肾脏护理服务商 Monogram Health 的 CEO Michael Uchrin 及多位高管被正式任命为纳什维尔医疗保健委员会（Nashville Health Care Council）董事会成员。解读：作为价值导向护理（Value-Based Care）的领军企业，Monogram Health 的入选标志着居家透析和慢病管理模式在主流医疗决策圈层中的影响力进一步提升。信息来源： Monogram Health Press Release 药物研发与临床试验 (Therapeutics & Clinical Trials) 4. 《柳叶刀》发表 BI 764198 二期结果：FSGS 蛋白尿显著降低【顶级期刊】 1月28日，《柳叶刀》（The Lancet）正式发表了勃林格殷格翰（Boehringer Ingelheim）在研药物 Apecotrep (BI 764198) 的二期临床详细数据。数据：研究显示，作为一种新型 TRPC6 抑制剂，20mg 剂量的 Apecotrep 在治疗12周后，使原发性局灶节段性肾小球硬化（FSGS）患者的蛋白尿水平较安慰剂组显著降低了 40%。三期临床试验目前已启动招募。信息来源： The Lancet / Boehringer Ingelheim 5. Idorsia 宣布将在 WORLDSymposium 公布 Fabry 病肾脏活检数据【会议预告】 1月30日，Idorsia 宣布将在即将于2月2日开幕的 WORLDSymposium 大会上，公布其口服药物 Lucerastat 治疗法布雷病（Fabry Disease）长达42个月的长期随访数据。看点：业界高度关注即将披露的肾脏活检结果，这将是评估该底物减少疗法能否在组织学层面真正逆转或稳定肾脏病变的关键证据。信息来源： BioSpace / Idorsia Ltd 6. Vera Therapeutics IgA 肾病新药获 FDA 优先审评资格【监管速递】据 DocWire News 1月27日周报回顾，FDA 已正式授予 Vera Therapeutics 的 Atacicept 生物制品许可申请（BLA）优先审评资格，用于治疗 IgA 肾病。预期： PDUFA 目标日期定于2026年7月。基于此前发布的36周数据（蛋白尿降低42%），该药有望成为首个靶向双重 B 细胞因子的 IgAN 疗法。信息来源： DocWire News / FDA Updates 前沿医学研究 (Cutting-edge Research) 7. Nature Comms：碱基编辑技术成功逆转多囊肾（ADPKD）进程【基因治疗】 1月29日，梅奥诊所（Mayo Clinic）研究团队在《Nature Communications》发表重磅研究。突破：研究人员利用 CRISPR 碱基编辑技术（Base Editing），在临床前模型中成功修正了导致常染色体显性多囊肾病（ADPKD）的 PKD1 基因突变。单次治疗不仅减缓了囊肿生长，还改善了肾功能并延长了生存期，为遗传性肾病的治愈性疗法带来了新希望。信息来源： Nature Communications / Mayo Clinic News 8. NEJM：10分钟新型扫描技术可精准定位高血压病灶，预防肾损伤【诊断革新】 1月29日，《新英格兰医学杂志》（NEJM）发表通讯文章，介绍了一种新型 CT 扫描技术。发现：这种基于新型示踪剂的10分钟扫描可精准发现导致高血压的微小肾上腺结节（醛固酮瘤）。对于伴有难治性高血压的 CKD 患者，该技术有助于通过微创手术切除病灶，从而替代终身服药并显著降低高血压对肾脏的进一步损害。信息来源： New England Journal of Medicine 9. Nature Medicine：粪菌移植（FMT）可降低肾癌免疫治疗毒性【肿瘤肾病】 1月28日，发表在《Nature Medicine》上的一项研究揭示了肠道菌群与肾脏健康的深层联系。机制：临床试验显示，接受特定供体粪菌移植（FMT）的晚期肾细胞癌患者，在接受免疫检查点抑制剂治疗时，其治疗相关的免疫毒性（包括肾毒性）显著降低，且治疗响应率有所提升。这为“肠-肾轴”在临床治疗中的应用提供了直接证据。信息来源： Nature Medicine / EurekAlert 10. JASN 新刊：肾脏生酮作用在缺血性损伤中的保护机制【基础机制】《美国肾脏病学会杂志》（JASN）2026年2月刊（1月底上线）发表了一项关于肾脏代谢的重要研究。结论：研究发现，虽然肝脏是主要的生酮器官，但在急性肾损伤（AKI）等应激状态下，近端肾小管的 HMGCS2 酶会被诱导表达，启动局部的生酮作用。这种代谢重编程并非为了向全身供能，而是作为一种内源性保护机制，对抗缺血性肾损伤。信息来源： JASN (Journal of the American Society of Nephrology) 编者按：本周不仅是器械安全的里程碑（Outset获批），更是基础科研向临床转化的爆发周。从 Nature 子刊的基因编辑与菌群移植，到 Lancet 的新药实锤，科技正在以前所未有的速度重塑肾脏病的诊疗版图。 (本文信息检索自全球公开新闻与学术期刊，仅供专业参考)

临床2期优先审批临床3期

2026-02-02

·Global血透讯息

全球血透资讯周报（1.27-2.2）

🚀 产业与器械重磅 (Industry & Devices)1. Outset Medical 新一代 Tablo 透析系统获 FDA 510(k) 批准【器械创新】 1月27日，Outset Medical 宣布其新一代 Tablo® 血液透析系统获得 FDA 510(k) 许可。核心亮点：此次获批使 Tablo 成为首个符合 FDA 2025年最新、最严苛网络安全（Cybersecurity）指南的透析设备。临床意义：新系统不仅在硬件耐用性上进行了升级以适应医院急症环境，更在数据传输安全性上建立了新行业标准，计划于2026年第二季度正式向客户发货。信息来源： Outset Medical Official Press Release / GlobeNewswire 2. Quanta 透析系统扩展急重症应用，播客披露最新战略【重症肾脏病】 1月29日，在最新的医疗制造行业播客中，Quanta Dialysis Technologies 披露了其便携式透析系统在急重症护理（Critical Care）领域的最新部署进展。进展：基于其 FDA 获批的连续性肾脏替代治疗（CRRT）功能，Quanta 正通过与 Innovative Renal Care 的战略合作，加速在 ICU 场景下的应用，旨在解决传统大型 CRRT 设备操作复杂的问题。信息来源： Medical Design & Development / Quanta News 3. Monogram Health 高管入选纳什维尔医疗委员会，强化居家肾病护理话语权【行业动态】 1月27日消息，居家肾脏护理服务商 Monogram Health 的 CEO Michael Uchrin 及多位高管被正式任命为纳什维尔医疗保健委员会（Nashville Health Care Council）董事会成员。解读：作为价值导向护理（Value-Based Care）的领军企业，Monogram Health 的入选标志着居家透析和慢病管理模式在主流医疗决策圈层中的影响力进一步提升。信息来源： Monogram Health Press Release 💊 药物研发与临床试验 (Therapeutics & Clinical Trials) 4. 《柳叶刀》发表 BI 764198 二期结果：FSGS 蛋白尿显著降低【顶级期刊】 1月28日，《柳叶刀》（The Lancet）正式发表了勃林格殷格翰（Boehringer Ingelheim）在研药物 Apecotrep (BI 764198) 的二期临床详细数据。数据：研究显示，作为一种新型 TRPC6 抑制剂，20mg 剂量的 Apecotrep 在治疗12周后，使原发性局灶节段性肾小球硬化（FSGS）患者的蛋白尿水平较安慰剂组显著降低了 40%。三期临床试验目前已启动招募。信息来源： The Lancet / Boehringer Ingelheim 5. Idorsia 宣布将在 WORLDSymposium 公布 Fabry 病肾脏活检数据【会议预告】 1月30日，Idorsia 宣布将在即将于2月2日开幕的 WORLDSymposium 大会上，公布其口服药物 Lucerastat 治疗法布雷病（Fabry Disease）长达42个月的长期随访数据。看点：业界高度关注即将披露的肾脏活检结果，这将是评估该底物减少疗法能否在组织学层面真正逆转或稳定肾脏病变的关键证据。信息来源： BioSpace / Idorsia Ltd 6. Vera Therapeutics IgA 肾病新药获 FDA 优先审评资格【监管速递】据 DocWire News 1月27日周报回顾，FDA 已正式授予 Vera Therapeutics 的 Atacicept 生物制品许可申请（BLA）优先审评资格，用于治疗 IgA 肾病。预期： PDUFA 目标日期定于2026年7月。基于此前发布的36周数据（蛋白尿降低42%），该药有望成为首个靶向双重 B 细胞因子的 IgAN 疗法。信息来源： DocWire News / FDA Updates 🔬 前沿医学研究 (Cutting-edge Research) 7. Nature Comms：碱基编辑技术成功逆转多囊肾（ADPKD）进程【基因治疗】 1月29日，梅奥诊所（Mayo Clinic）研究团队在《Nature Communications》发表重磅研究。突破：研究人员利用 CRISPR 碱基编辑技术（Base Editing），在临床前模型中成功修正了导致常染色体显性多囊肾病（ADPKD）的 PKD1 基因突变。单次治疗不仅减缓了囊肿生长，还改善了肾功能并延长了生存期，为遗传性肾病的治愈性疗法带来了新希望。信息来源： Nature Communications / Mayo Clinic News 8. NEJM：10分钟新型扫描技术可精准定位高血压病灶，预防肾损伤【诊断革新】 1月29日，《新英格兰医学杂志》（NEJM）发表通讯文章，介绍了一种新型 CT 扫描技术。发现：这种基于新型示踪剂的10分钟扫描可精准发现导致高血压的微小肾上腺结节（醛固酮瘤）。对于伴有难治性高血压的 CKD 患者，该技术有助于通过微创手术切除病灶，从而替代终身服药并显著降低高血压对肾脏的进一步损害。信息来源： New England Journal of Medicine 9. Nature Medicine：粪菌移植（FMT）可降低肾癌免疫治疗毒性【肿瘤肾病】 1月28日，发表在《Nature Medicine》上的一项研究揭示了肠道菌群与肾脏健康的深层联系。机制：临床试验显示，接受特定供体粪菌移植（FMT）的晚期肾细胞癌患者，在接受免疫检查点抑制剂治疗时，其治疗相关的免疫毒性（包括肾毒性）显著降低，且治疗响应率有所提升。这为“肠-肾轴”在临床治疗中的应用提供了直接证据。信息来源： Nature Medicine / EurekAlert 10. JASN 新刊：肾脏生酮作用在缺血性损伤中的保护机制【基础机制】《美国肾脏病学会杂志》（JASN）2026年2月刊（1月底上线）发表了一项关于肾脏代谢的重要研究。结论：研究发现，虽然肝脏是主要的生酮器官，但在急性肾损伤（AKI）等应激状态下，近端肾小管的 HMGCS2 酶会被诱导表达，启动局部的生酮作用。这种代谢重编程并非为了向全身供能，而是作为一种内源性保护机制，对抗缺血性肾损伤。信息来源： JASN (Journal of the American Society of Nephrology) 编者按：本周不仅是器械安全的里程碑（Outset获批），更是基础科研向临床转化的爆发周。从 Nature 子刊的基因编辑与菌群移植，到 Lancet 的新药实锤，科技正在以前所未有的速度重塑肾脏病的诊疗版图。 (本文信息检索自全球公开新闻与学术期刊，仅供专业参考)

100 项与 Apecotrep 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
局灶性节段性肾小球硬化症	临床3期	美国	Boehringer Ingelheim GmbH	2026-01-07
局灶性节段性肾小球硬化症	临床3期	中国	Boehringer Ingelheim GmbH	2026-01-07
局灶性节段性肾小球硬化症	临床3期	日本	Boehringer Ingelheim GmbH	2026-01-07
局灶性节段性肾小球硬化症	临床3期	阿根廷	Boehringer Ingelheim GmbH	2026-01-07
局灶性节段性肾小球硬化症	临床3期	澳大利亚	Boehringer Ingelheim GmbH	2026-01-07
局灶性节段性肾小球硬化症	临床3期	比利时	Boehringer Ingelheim GmbH	2026-01-07
局灶性节段性肾小球硬化症	临床3期	巴西	Boehringer Ingelheim GmbH	2026-01-07
局灶性节段性肾小球硬化症	临床3期	加拿大	Boehringer Ingelheim GmbH	2026-01-07
局灶性节段性肾小球硬化症	临床3期	克罗地亚	Boehringer Ingelheim GmbH	2026-01-07
局灶性节段性肾小球硬化症	临床3期	丹麦	Boehringer Ingelheim GmbH	2026-01-07

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05213624 (CTgov)	临床2期	局灶性节段性肾小球硬化症 \| 慢性肾病	67	BI 764198 (BI 764198 20 mg)	鬱網夢襯築鑰鏇積繭艱 = 範餘鏇獵製鹹醖餘餘願襯獵齋範獵膚廠膚鹹觸 (蓋鑰鏇餘鬱積顧鑰廠糧, 觸網廠構壓鹽窪築鏇憲 ~ 獵窪鏇獵憲糧鹽襯鏇遞) 更多	-	2026-01-12
				BI 764198 (BI 764198 40 mg)	鬱網夢襯築鑰鏇積繭艱 = 夢衊積範鏇齋築艱獵鹹襯獵齋範獵膚廠膚鹹觸 (蓋鑰鏇餘鬱積顧鑰廠糧, 鏇簾顧蓋艱鏇網廠鑰鬱 ~ 繭願襯簾鏇餘獵鏇襯網) 更多
NCT05213624 (ASN2025)	临床2期	局灶性节段性肾小球硬化症	60	BI 764198	憲膚蓋膚鹹壓蓋選製繭(鏇鹹繭構構顧鑰願顧夢) = 夢膚網顧築衊鑰醖鹽齋窪繭鏇膚鬱衊範鏇網鏇 (範鹹襯壓壓蓋選繭窪鹹 )	积极	2025-11-08
				BI 764198	憲膚蓋膚鹹壓蓋選製繭(鏇鹹繭構構顧鑰願顧夢) = 艱鬱壓簾夢憲鹽壓壓衊窪繭鏇膚鬱衊範鏇網鏇 (範鹹襯壓壓蓋選繭窪鹹 )
NCT04102462 \| NCT03854552 \| NCT04176536 \| NCT04656288 (Phase 1 trials of BI 764198, Pubmed \| Expert Opin Investig Drugs)	临床1期	肾功能不全	54	BI 764198	艱衊襯夢製構餘鬱鑰淵(膚網醖鹹獵鹹憲餘醖齋) = 1 participant (16.7%) experienced diarrhea 壓壓衊壓鑰壓淵廠範淵 (選構構築簾選網廠網製 ) 更多	积极	2025-06-08
				Placebo
NCT04665700 (Pubmed \| Expert Opin Investig Drugs)	临床1期	TRPC6	44	BI 764,198 20 mg	蓋襯糧鹹鹽糧糧窪遞範(襯窪範繭遞範淵衊簾齋) = 遞衊選繭壓夢鹹鏇餘繭繭遞鏇餘艱選窪蓋鹹衊 (鬱壓夢製繭淵鹹積艱壓 ) 更多	-	2025-05-04
				Placebo	蓋襯糧鹹鹽糧糧窪遞範(襯窪範繭遞範淵衊簾齋) = 鏇繭鏇衊網鑰選窪築願繭遞鏇餘艱選窪蓋鹹衊 (鬱壓夢製繭淵鹹積艱壓 ) 更多
NCT04604184 (Pubmed)	临床2期	新型冠状病毒感染	-	BI 764198	觸齋壓膚選簾醖夢繭鹽(艱醖顧築餘遞獵鬱襯範): days = 3.41 (95% CI, 0.49 ~ 6.34) 更多	不佳	2023-04-06
				Placebo
NCT04604184 (CTgov)	临床2期	新型冠状病毒感染 \| 急性呼吸窘迫综合征	133	BI 764198 (BI 764198 Treatment Group)	鑰觸壓醖鏇衊憲簾鬱繭 = 選願餘獵鏇蓋糧夢憲衊獵鏇襯網鏇顧繭鹹鏇簾 (膚膚糧繭簾鏇積艱齋觸, 觸襯膚構構鬱蓋鬱鬱獵 ~ 顧選範糧鏇醖製壓選蓋) 更多	-	2022-04-11
				Placebo (Placebo)	鑰觸壓醖鏇衊憲簾鬱繭 = 鬱淵醖憲艱衊鏇鑰餘衊獵鏇襯網鏇顧繭鹹鏇簾 (膚膚糧繭簾鏇積艱齋觸, 鏇襯觸蓋製鬱鹽願繭鬱 ~ 餘廠繭積鏇壓構餘鑰衊) 更多