EUCTR2015-005450-36-Outside-EU/EEA进行中（未招募）1 期
A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Arms With Switchover, Pilot Study to Evaluate the Efficacy and Safety of Intravenous Abatacept in Treatment Resistant Nephrotic Syndrome (Focal Segmental Glomerulosclerosis/ Minimal Change)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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 subjects ages = 6 years
- •Subjects resistant to corticosteroids, calcineurin inhibitors (cyclosporine and tacrolimus), sirolimus, mycophenolate mofetil (MMF), mycophenolic acid (MPA), or cyclophosphamide or intolerant to at least 2 of these
- •UPCR = 3 at screening
- •FSGS or MCD confirmed by renal biopsy
- •eGFR = 60 for children and = 45 for adults
- •Concomitant use of angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at stable doses for at least 2 weeks
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 54
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 37
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •Kidney diseases other than FSGS or MCD
- •Collapsing FSGS
- •Systemic lupus erythematosus
- •Diabetes mellitus, both type 1 and type 2
- •Clinically significant congestive heart failure
- •Body mass index (BMI): > 40 in subjects = 18 years of age and = 99% percentile for subjects < 18 years of age
研究者
相似试验
进行中（未招募）
1 期
Study to Asses the Safety and Efficacy of Multiple Doses of Ionis-FB-LRX in patients with Geographic Atrophy Secondary to Age-Related Macular DegeneratioEUCTR2020-005174-94-ATIonis Pharmaceuticals, Inc.330
进行中（未招募）
1 期
Study to Asses the Safety and Efficacy of Multiple Doses of Ionis-FB-LRX in patients with Geographic Atrophy Secondary to Age-Related Macular DegeneratioGeographic atrophy (GA) secondary to age-related macular degeneration (AMD)MedDRA version: 20.1Level: PTClassification code 10064930Term: Age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.1Level: LLTClassification code 10063947Term: Geographic atrophySystem Organ Class: 10015919 - Eye disordersEUCTR2020-005174-94-ESIonis Pharmaceuticals, Inc.355
进行中（未招募）
1 期
Study to Asses the Safety and Efficacy of Multiple Doses of Ionis-FB-LRX in patients with Geographic Atrophy Secondary to Age-Related Macular DegeneratioGeographic atrophy (GA) secondary to age-related macular degeneration (AMD)MedDRA version: 20.1Level: PTClassification code 10064930Term: Age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.1Level: LLTClassification code 10063947Term: Geographic atrophySystem Organ Class: 10015919 - Eye disordersEUCTR2020-005174-94-NLIonis Pharmaceuticals, Inc.355
进行中（未招募）
1 期
Study to Asses the Safety and Efficacy of Multiple Doses of Ionis-FB-LRX in patients with Geographic Atrophy Secondary to Age-Related Macular DegeneratioGeographic atrophy (GA) secondary to age-related macular degeneration (AMD)MedDRA version: 20.1Level: PTClassification code 10064930Term: Age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.1Level: LLTClassification code 10063947Term: Geographic atrophySystem Organ Class: 10015919 - Eye disordersEUCTR2020-005174-94-CZIonis Pharmaceuticals, Inc.330
进行中（未招募）
1 期
Phase 2 Study to see if RMC-035 is effective and safe in Subjects at High Risk for Acute Kidney Injury following Cardiac SurgeryCardiac surgery associated acute kidney injuryMedDRA version: 21.1Level: PTClassification code 10069339Term: Acute kidney injurySystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2021-004040-19-DEGuard Therapeutics International AB268