A Phase 2 Open-label Trial Evaluating the Efficacy and Safety of Daratumumab in Treatment of Patients With Active Lupus Nephritis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Efficacy of daratumumab in inducing complete(CR) or partial(PR) renal remission in patients with active class III or IV Lupus Nephritis
研究概览
简要总结
The purpose of this research is to study the safety and efficacy of daratumumab in inducing complete or partial remission in patients with active lupus nephritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years of age.
- •Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria.
- •Renal biopsy confirming the diagnosis of active class III/IV (± class V) LN (based on International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003) within 12 months of enrollment.
- •Proteinuria ≥ 500 mg over 24 hours.
- •eGFR ≥ 30 ml/min/SA.
- •Subjects should be able to give informed consent.
排除标准
- •Pregnancy.
- •Hepatitis B or C, HIV
- •Anemia with Hgb < 8.0 g/dL.
- •Thrombocytopenia with platelet count < 100'
- •Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication.
- •Unable to provide consent.
- •Patients receiving > 10 mg of oral prednisone or glucocorticoid equivalent if on corticosteroids for > 2 weeks (patients would be allowed to be on > 10 mg of prednisone or its oral equivalent as long as the duration is ≤ 2 weeks).
- •Patients who had received immunosuppressive therapy including cyclosporine, tacrolimus or azathioprine in the last 3 months.
- •Patients who have received cyclophosphamide in the last 6 months.
- •Patients who received rituximab previously with CD20 count of zero at the time of enrollment.
- •Patient are allowed to be on MMF at time of enrollment but no higher than total of 1500mg/day.
- •For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (<) 1 percent (%) per year, during the treatment period and for at least 12 months after the last dose of study drug.
- •For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 12 months after the last dose of study drug and agreement to refrain from donating sperm during this same period.
- •Patients with diagnosis of glaucoma.
研究组 & 干预措施
Daratumumab
Subjects diagnosed with lupus nephritis will receive Daratumumab once weekly for 8 weeks and then once every 2 weeks for 8 additional does (+/- 4 days). Subjects will be followed for a total of 24 months (18 months after the last daratumumab administration).
干预措施: Daratumumab (Drug)
结局指标
主要结局
Efficacy of daratumumab in inducing complete(CR) or partial(PR) renal remission in patients with active class III or IV Lupus Nephritis
时间窗: 12 months after first infusion of Daratumumab
Complete Renal Response:- \< 500 mg proteinuria/24 hours, Inactive urinary sediment (\<10 RBC/HPF and absence of RBC casts), No greater than a 15% reduction in eGFR from enrollment
Efficacy of daratumumab in inducing complete(CR) or partial(PR)
时间窗: 12 months after first infusion of Daratumumab
Partial Renal Response: \> 50% reduction in 24-hour proteinuria and proteinuria \< 1g/24hr if baseline 24hr proteinuria, - ≤3 g/24hr and proteinuria ≤ 3 g/24hr if starting proteinuria \> 3 g/24hrs. , Improved urinary sediment (\>=50% reduction in RBC/HPF and absence of RBC casts), No greater than a 20% reduction in baseline eGFR
次要结局
- Change in hematuria.(Baseline,6, 12, 18 and 24 months after first infusion of Daratumumab)
- Safety of daratumumab in patients with active class III/IV LN.(24 months after first infusion of Daratumumab)
- Improvement from proteinuria(Baseline, 6, 12, 18 and 24 months after first infusion of Daratumumab)
- Improvement in eGFR(Baseline, 6, 12, 18 and 24 months after first infusion of Daratumumab)
- Change in ds-DNA(Baseline, 6, 12, 18 and 24 months after first infusion of Daratumumab)
研究者
Fernando Fervenza
Principal Investigator
Mayo Clinic