NCT07020923进行中（未招募）2 期
A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients With IgAN
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Evaluate the effect of atacicept on Gd-IgA1 in patients with IgAN
研究概览
简要总结
This is a Phase 2, open-label, multicenter, randomized study comprising parallel groups of participants receiving weekly and/or monthly doses of atacicept
详细描述
This Phase 2 study is to explore the effectiveness, safety and tolerability of different dosing regimens of atacicept. Regimens include monthly and weekly dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments
- •Adult male or female of ≥18 years of age, or as per country specific legally or nationally recognized adult age, who provides written informed consent prior to performing any study assessments
- •Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
- •Total urine protein excretion ≥0.75 g per 24-hour or urine protein-to-creatinine ratio (UPCR) ≥0.75 mg/mg based on a 24-hour urine sample
- •eGFR ≥30 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
- •On a stable prescribed regimen of RASi (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker) for at least 8 weeks that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1
排除标准
- •IgAN secondary to another condition (eg, liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (ie, Henoch-Schonlein purpura), systemic lupus erythematosus, dermatitis herpetiformis, ankylosing spondylitis
- •Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening)
- •Evidence of nephrotic syndrome within 6 months of screening (serum albumin <3.0 g/dL in association with UPCR >3.5 mg/mg)
- •Renal or other organ transplantation prior to or expected during the study, with the exception of corneal transplants
- •Concomitant chronic renal disease in addition to IgAN (eg, diabetic nephropathy, primary focal segmental glomerulosclerosis, membranous nephropathy, C3 glomerulopathy, lupus nephritis)
研究组 & 干预措施
Atacicept Arm 5
Experimental
Atacicept dose E administered subcutaneous (sc) injection weekly for 24 weeks, followed by monthly sc injections
Atacicept Arm 4
Experimental
Atacicept dose D administered subcutaneous (sc) injection weekly
Atacicept Arm 2
Experimental
Atacicept dose B administered subcutaneous (sc) injection monthly
Atacicept Arm 3
Experimental
Atacicept dose C administered subcutaneous (sc) injection monthly
Atacicept Arm 1
Experimental
Atacicept dose A administered subcutaneous (sc) injection monthly
干预措施: Atacicept (Drug)
结局指标
主要结局
Evaluate the effect of atacicept on Gd-IgA1 in patients with IgAN
时间窗: Up to 24 weeks
Gd-IgA1 levels through Week 24
次要结局
- To evaluate the safety and tolerability of atacicept at different dosing regimensT(Baseline until end of study up to Week 24)
- To evaluate the effect of atacicept on serum immunoglobulins (IgA)(24 Weeks)
- To evaluate the effect of atacicept on serum immunoglobulins (IgG)(24 Weeks)
- To evaluate the effect of atacicept on serum immunoglobulins (IgM)(24 Weeks)
- To evaluate serum PK of atacicept(Baseline until end of study up to Week 24)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Randomized Study on Multiple Cycles of Interleukin-7 in HIV Patients Immune Non-respondersHIVNCT01241643Cytheris SA92
已完成
2 期
The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseNCT03487913Palladio Biosciences31
已完成
2 期
Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic ConjunctivitisAllergic ConjunctivitisNCT00836485Senju USA, Inc.122
已完成
2 期
A Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected With Chronic HBVHepatitis BHepatitis, ViralNCT02751996F-star Therapeutics, Inc.80
已完成
2 期
Assessment of the Safety, Efficacy, PK, and Extrapulmonary Pharmacodynamics (PD) of Albuterol Sulfate Pressurized Inhalation Suspension (Hereafter Referred to as AS MDI) Compared to Proventil as an Active Control in Subjects With AsthmaAsthmaNCT03371459AstraZeneca46