SLCTR/2022/010尚未招募2 期
A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients with IgA Nephropathy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female >18 years of age
- •2.Biopsy proven IgAN
- •3.Urine protein > 0.75g/24 hours at Screening despite optimization with ACE inhibitors or angiotensin receptor blockers (ARB)
- •4.eGFR >45 mL/min per 1.73 m2 or eGFR < 45 mL/min per 1.73 m2 and >30 mL/min per 1.73 m2 with a kidney biopsy within 2 years of Screening showing < 50% tubulointerstitial fibrosis
- •5.Agree to comply with contraception requirements during and for 90 days after study completion.
排除标准
- •1.Any secondary IgAN as defined by the investigator
- •2.Patients who have undergone a kidney transplant
- •3.Any history of kidney disease other than IgAN
- •4.Any history of diabetes (Type 1 or Type 2)
- •5.Seated blood pressure > 140 mmHg (systolic) or > 90 mmHg (diastolic) at the Screening Visit. Patients must be on a stable dose and regimen of an ACE inhibitor or ARB for at least 90 days
- •6.Significant liver disease,;
- •7.Pregnancy or breastfeeding;
- •8.Concurrent participation in another interventional study or treatment with an investigational drug
研究者
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