2022-502102-32-00招募中3 期
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of RO7434656, an Antisense Inhibitor of Complement Factor B, in Patients with Primary IgA Nephropathy at High Risk of Progression
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 87
- 试验地点
- 39
- 主要终点
- Change in proteinuria, as measured by the UPCR change at Week 37 from baseline from a 24-hour collection
研究概览
简要总结
To evaluate the efficacy of RO7434656 compared with placebo on the basis of change in proteinuria, as measured by the urine protein-to-creatinine ratio (UPCR) change at Week 37 from baseline from a 24-hour collection
研究设计
- 分配方式
- Randomized
- 主要目的
- Wa43966
- 盲法
- Double (Analyst, Investigator, Carer, Subject, Monitor)
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
- 是
入选标准
- •Primary IgA nephropathy (IgAN), as evidenced by a kidney biopsy performed within 10 years prior to or during screening, without known secondary cause.
- •Treatment with maximum tolerated doses of angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) for at least 90 days immediately prior to screening, except for interruptions due to illness (not greater than 7 consecutive days) ), unless the potential participant is intolerant to these medications
- •UPCR ≥ 1 g/g or urine protein excretion ≥ 1 g/day (with UPCR ≥ 0.8 g/g), all measured from a 24-hour urine collection during screening
- •eGFR ≥ 20 mL/min/1.73 m2, as calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation
- •Vaccination against Neisseria meningitidis < 3 years prior to initiation of study treatment and against Streptococcus pneumoniae. Vaccination against Haemophilus influenzae according to national vaccination recommendations for patients receiving complement inhibitors
- •Agree to use protocol defined methods of contraception by female participants and no contraception requirements for male participants
排除标准
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 weeks after the final dose of RO7434656
- •Histopathologic or other evidence of another autoimmune glomerular disease
- •Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg
- •Previous treatment with RO7434656
- •History of malignancy within <5 years prior to screening
- •Hemoglobin A1c ≥ 6.5% or a clinical diagnosis of diabetes mellitus of any type
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Change in proteinuria, as measured by the UPCR change at Week 37 from baseline from a 24-hour collection
Change in proteinuria, as measured by the UPCR change at Week 37 from baseline from a 24-hour collection
次要结局
- Estimated eGFR slope at Week 105 from baseline. eGFR will be calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation
- Time to the composite kidney failure endpoint, defined as receipt of kidney transplantation, need for kidney replacement therapy, a sustained decline in eGFR of ≥ 30% from baseline, or a sustained eGFR < 15 mL/min/1.73m2 over at least 4 weeks (both eGFR criteria requiretwo consecutive central laboratory eGFR values meeting criteria ≥ 4 weeks apart), whichever occurs first, without the receipt of other immunosuppressive or background therapies for the treatment of IgAN
- Change in fatigue at Week 105 compared with baseline, as assessed through the use of the Functional Assessment of Chronic Illness Therapy−Fatigue Scale
- Incidence and severity of treatment-emergent adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 grading scale
- Plasma concentrations of RO7434656 conjugated and/or unconjugated equivalent at specified timepoints
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (39)
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