NCT07146906招募中2 期
An Open-label, Multicenter Study to Assess the Effect of Zigakibart Treatment on Histologic, Circulating, and Excreted Markers of Kidney Disease and Dysfunction in Adult Patients With IgA Nephropathy.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 29
- 主要终点
- Change in mesangial IgA deposition
研究概览
简要总结
The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.
详细描述
This is an open-label multicenter study where participants are randomized into one of two groups, where the only difference between the groups is the on-treatment biopsy time point, end of the first year of treatment (Group A) or at the end of the second year of treatment (Group B).
The total study duration for each participant may be up to 125 weeks, including the maximum screening period (8 weeks), the treatment period (104 weeks), and the safety follow up period (13 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary IgAN, confirmed by kidney biopsy, within 5 years prior to Screening
- •eGFR ≥45 mL/min/1.73 m2, based on the 2021 CKD-EPI equation, at Screening
- •Persistent proteinuria, defined as either
- •Total Urine Protein ≥0.5 g/day or UPCR ≥0.5 g/g in a 24-hour urine collection, at Screening, despite maximally tolerated dose or poorly tolerated supportive therapy or
- •IgAN diagnosis <6 months prior to Screening with Total Urine Protein >1.5 g/day or UPCR >1.5 g/g in a 24-hour urine collection, at the time of clinical presentation or diagnosis
- •Body weight ≥45 kg and body mass index (BMI) ≤35.0 kg/m2, at Screening
排除标准
- •Secondary forms of IgAN, as determined by the Investigator, diagnosis of IgA vasculitis, or any other nephropathy or chronic urinary tract disorder
- •Total IgG <6.0 g/L at screening
- •Any chronic urinary tract disorder, including but not limited to retention, incontinence, and/or recurrent urinary tract infections
- •An average systolic blood pressure >150 mmHg or average diastolic blood pressure >90 mmHg based on three measurements at Screening
- •Treatment with complement pathway inhibitors, mycophenolic acids, systemic calcineurin inhibitors or corticosteroids, immunosuppressive or immunomodulatory agents within 12 months prior to screening
- •Acute kidney injury (AKI), defined by AKI network criteria, within 4 weeks prior to screening
- •Current treatment with anti-APRIL monoclonal antibodies or dual APRIL/BAFF inhibitors or past treatment of the same at any time for >3 consecutive months prior to screening
- •Planned initiation of, or recently (within 24 weeks) initiated, treatment with glucagon-like peptide-1 agonists at screening
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
zigakibart
Experimental
zigakibart injections every second week for two years
干预措施: zigakibart (Biological)
结局指标
主要结局
Change in mesangial IgA deposition
时间窗: Baseline to Week 53 or 105
Change in mesangial IgA deposition as assessed by intensity of immunofluorescence staining
次要结局
- Change in eGFR(Baseline to Week 53 and 105)
- Change in MEST-C score(Baseline to Week 53 or 105)
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 to Week 118)
- Change in CD68+ cells in glomeruli and tubulo-interstitial compartment(Baseline to Week 53 or 105)
- Change in complement component C3c(Baseline to Week 53 or 105)
- Change in UPCR(Baseline to Week 53 and 105)
- Change in albuminuria(Baseline to Week 53 and 105)
- Change in hematuria(Baseline to Week 53 and 105)
- Change in serum IgA, IgM and IgG(Baseline to Week 13, 29, 53, 79 and 105)
- Serum zigakibart concentrations(Baseline, Week 13, 29, 66, 79 and 105)
- Circulating anti-zigakibart antibodies(Baseline, Week 13, 29, 66, 79 and 105)
研究者
研究点 (29)
Loading locations...
相似试验
招募中
3 期
Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.GlomerulonephritisKidney Diseases, ChronicUrological DiseasesKidney DiseasesGlomerular DiseaseGlomerulonephritis, IGAGlomerulopathyImmunoglobulin DiseaseNCT06858319Novartis Pharmaceuticals220
已完成
4 期
Rituximab in Progressive Immunoglobulin A (IgA) NephropathyIgA NephropathyNCT00498368Mayo Clinic34
招募中
2 期
A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia GravisMyasthenia GravisNCT05265273Janssen Research & Development, LLC12
已完成
3 期
Treatment of IgA Nephropathy According to Renal LesionsIgA NephropathyNCT03188887Assistance Publique - Hôpitaux de Paris62
已完成
不适用
Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA NephropathyIgA NephropathyNCT02526966Centre Hospitalier Universitaire de Saint Etienne68