NCT07642050尚未招募3 期
A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BHV-1400 in the Treatment of IgA Nephropathy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 420
研究概览
简要总结
The purpose of this study is to determine if BHV-1400 is effective and safe in the treatment of IgA Nephropathy. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IgAN as confirmed by renal biopsy conducted within 10 years prior to Screening.
- •If a participant has a history of diabetes, the biopsy must have been conducted within 2 years prior to Screening with no evidence of diabetic nephropathy.
- •In all cases, if a historical biopsy report is not available, a biopsy may be performed prior to Screening.
- •UPCR ≥ 0.75 g/g or UPE ≥ 1.0 g/d determined via 24 hour collection.
- •eGFR ≥ 30 mL/min/1.73m2 (CKD-EPI equation).
- •Participants must have been on supportive care including a stable dose regimen of ACEi or ARB (at the locally approved maximal daily dose or the maximally tolerated dose per Investigators' judgment) for at least 90 days prior to Screening. Subjects who are not able to tolerate ACEi or ARB therapy may be eligible for participation in the trial if their overall management including blood pressure control is as per local applicable guidelines. This must be discussed with the medical monitor and documented by the Investigator.
- •Patients may be on a dual endothelin angiotensin receptor antagonist (DEARA) or endothelin receptor antagonist (ERA) but must be on a stable dose for at least 90 days prior to Screening and they must remain on a stable dose throughout the course of the study. Participants may be on a sodium-glucose cotransporter 2 (SGLT2) inhibitor, mineralocorticoid receptor antagonist (including Finerenone), but must be on a stable dose for 90 days prior to Screening and must remain on a stable dose throughout the course of the study.
排除标准
- •Any secondary IgAN as defined by the Investigator; secondary IgAN can be associated with cirrhosis, celiac disease, HIV infection, herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, familial Mediterranean fever, etc. NOTE: IgA Vasculitis excluded if patient has had any IgA Vasculitis related extrarenal signs or symptoms, or requirement for steroid or other immunosuppressive therapy in the past year.
- •Any cause of chronic kidney disease that is not diagnosed as IgAN or may be due to non-IgAN cause, such as diabetic nephropathy. If presence of other kidney disease or concurrent glomerulopathies felt to be non-dominant, consideration for inclusion must be discussed with and approved by the Sponsor Medical Monitor/Sponsor Designee.
- •Presence of rapidly progressive glomerulonephritis as defined by 50% decline in eGFR within 3 months prior to Screening.
- •Evidence of nephrotic syndrome, defined as 24-hour protein > 3.5g with concurrent hypoalbuminemia (Albumin < 3.0 g/dl), within 6 months of Screening
- •End-stage renal disease requiring dialysis or transplantation
研究者
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