EUCTR2020-000384-23-DE进行中（未招募）1 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 - PoCP study in FSGS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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 FSGS or documented TRPC6 gene mutation causing FSGS prior to screening visit.
- •- 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 ACE inhibitors, ARBs, finerenone, aldosterone inhibitors, or 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). Men must be willing and able to use condom if their partner is a WOCBP.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
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).
- •- 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. Note: use of other immunosuppression therapies considered as standard of care may be allowed as long as the
- •patient remains on stable dose throughout the study.
- •- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (CKD EPI formula based on serum creatinine and cystatin C) at screening visit.
- •- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >3X the upper limit of normal (ULN) at screening visit.
- •- QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator's discretion) at screening visit.
- •- Detection of graded cataract by LOCS III higher than NC1/NO1, C0, P0 in the slit lamp eye examination at screening visit. Planned cataract surgery during participation in the study. Patients with cataract who
- •have undergone lens replacement are not excluded.
- •- Women who are pregnant, nursing, or who plan to become pregnant while in the study.
- •Further criteria apply.
研究者
相似试验
进行中（未招募）
不适用
A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV) - ATMOSPHEREchronic heart failure (NYHA Class II - IV)MedDRA version: 16.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849EUCTR2008-004104-31-SEovartis Pharma Services AG7,046
进行中（未招募）
不适用
This study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality of patients with chronic heart failure.MedDRA version: 15.1Level: LLTClassification code 10008502Term: CHFSystem Organ Class: 100000004849Chronic Heart FailureEUCTR2009-015834-31-DEovartis Pharma Services AG7,980
进行中（未招募）
1 期
A multicenter, randomized, double-blind, Phase 2 study to assess ATX01 (topical study drug) in comparison to placebo, in cancer adult patients with chemotherapy-induced peripheral neuropathy (CIPN)chemotherapy-induced peripheral neuropathy (CIPN)MedDRA version: 20.1Level: LLTClassification code 10079545Term: Chemotherapy induced peripheral neuropathySystem Organ Class: 100000004852EUCTR2022-000435-23-CZAlgoTherapeutix240
进行中（未招募）
1 期
Study of efficacy and safety of iptacopan in complement 3 glomerulopathy patientscomplement 3 glomerulopathyMedDRA version: 20.0Level: PTClassification code 10077827Term: C3 glomerulopathySystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2020-004589-21-SKovartis Pharma AG83
进行中（未招募）
1 期
A clinical trial to evaluate efficacy and safety of aliskiren and aliskiren/enalapril combination compared to enalapril in patients with heart failure.Chronic heart failure (NYHA Class II - IV)MedDRA version: 16.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849EUCTR2008-004104-31-IEovartis Pharma AG7,046