NCT05237388已完成2 期
Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Percent change in albuminuria (UACR)
研究概览
简要总结
The purpose of this study is to determine if the drug, baricitinib, is safe and effective in reducing high levels of albumin in the urine (albuminuria) in African American/Blacks with APOL1- associated focal segmental glomerulosclerosis (FSGS) and non-diabetic APOL1-associated chronic kidney disease due to hypertension (HTN-CKD).
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
- Double (Participant, Investigator)
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
- •Adults 18-70 years
- •High Risk APOL1 genotype (i.e., G1G1, G2G2, or G1G2)
- •FSGS diagnosed by kidney biopsy or clinically diagnosed HTN-CKD
- •UACR ≥300 mg/dL
- •Estimated glomerular filtration rate (eGFR) ≥26 ml/min/1.73 m2 at screening
- •Stable antihypertensive regimen for ≥ 1 month prior to enrolment
- •Able to provide written informed consent
排除标准
- •Sickle cell disease.
- •Tip variant of FSGS.
- •Systolic BP >180 mmHg or diastolic BP >90 mmHg based on average of 3 measurements.
- •Active serious viral, bacterial, fungal or parasitic infection.
- •Symptomatic herpes zoster infection within 12 weeks prior to study entry.
- •Positive hepatitis B surface antigen during screening (could enroll after treatment).
- •Previous kidney transplant.
- •History of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the ULN or the most recent available total bilirubin ≥1.5 times the ULN
- •Hemoglobin <10 g/dL.
- •Absolute lymphocyte count (ALC)<500cells/mm3 or absolute neutrophil count (ANC) < 1000 cells/mm
- •Pregnant or nursing at time of enrollment
- •Prior or current treatment with JAK inhibitor.
- •Current use of potent immunosuppressants such as abatacept, adalimumab, anakinra, azathioprine, certolizumab, etanercept, golimumab, infliximab, probenecid, rituximab, ruxolitinib, sarilumab, tofacitinib, or tocilizumab.
- •High dose corticosteroids (>10 mg per day of prednisone or equivalent) or an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization.
研究组 & 干预措施
Baricitinib
Experimental
Participants will take one pill of Baricitinib daily with their regular medications.
干预措施: Baricitinib (Drug)
Placebo
Placebo Comparator
Participants will take a Baricitinib placebo pill matching Baricitinib daily with their regular medications.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change in albuminuria (UACR)
时间窗: Baseline, monthly for 6 months
次要结局
- Percent change in eGFR as measured by blood test(Baseline, monthly for 6 months)
- Percent change in urine CXCL 9-11 as measured by urine test(Baseline, monthly for 6 months)
- Number of adverse events as measured by patient report(Up to 6 months)
- Number of adverse events as measured by clinical lab value of hemoglobin less than 9.5g/dL(Up to 6 months)
研究者
研究点 (2)
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