NCT02006849撤回不适用
ACTH Treatment of APOL1- Associated Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in proteinuria with H.C. Acthar gel
研究概览
简要总结
The purpose of this research study is to determine if the study drug H.C. Acthar gel slows the progression of your kidney disease. This drug is a steroid-based medicine with fewer side effects than other steroids used for treatment of kidney diseases similar to APOL1 nephropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-diabetic African-American with two APOL1-risk genotypes
- •Age ≥21 years
- •BMI < 40 kg/m2
- •Hemoglobin A1c <6.5%
- •eGFR ≥30 ml/min/1.73m2
- •Historical urine protein: creatinine ratio ≥ 1.0 g/g
- •Strong clinical suspicion of APOL1-associated nephropathy or history of biopsy proven focal segmental glomerulosclerosis (FSGS) or focal global glomerulosclerosis (FGGS)
- •Women of childbearing potential: negative serum pregnancy test at Screening and agreement to follow a medically acceptable form of contraception for the duration of Acthar administration and 4 weeks thereafter
排除标准
- •Diagnosis of diabetes mellitus and/or on pharmacologic treatment for diabetes
- •Medical condition that could cause secondary FSGS
- •History of sensitivity to steroids (psychosis, steroid-induced diabetes)
- •Chronic systemic corticosteroid use (Prednisone or equivalent systemic steroid taken for more than 4 consecutive weeks within 6 months prior to screening). Intra-articular, inhaled, and topical steroids are not exclusion criteria.
- •Contraindication to Acthar per package insert: scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery (within previous 6 months), history of or the presence of peptic ulcer (within 6 months prior to Screening), adrenal insufficiency or hyperfunction.
- •Acute glaucoma diagnosed ≤3 months prior to Screening
- •Biopsy proven glomerular disease other than FSGS or FGGS
- •Live or live attenuated vaccine received within 1 month prior to screening, or planned administration once enrolled in the study
- •Uncontrolled hypertension (HTN) (≥ 180/110 mmHg) and frequent admissions (≥1 admission per 6 months interval) for hypertensive urgency or hypertensive emergency
- •Unstable cardiovascular disease: history of congestive heart failure (NYHA Functional Class III-IV); history of dilated cardiomyopathy with ejection fraction < 40%; any of the following events within 3 months of screening: unstable angina, myocardial infarction, coronary artery bypass graft or percutaneous transluminal coronary angioplasty, transient ischemic attack or cerebrovascular accident, unstable arrhythmia
- •Uncontrolled volume overload: history of moderate or severe peripheral edema; on loop diuretics ≥ 120 mg daily of furosemide or ≥ 3.0 mg daily of bumetanide or ≥ 150 mg daily of ethacrynic acid or ≥ 60 mg daily of torsemide;
- •History of secondary hypertension (i.e., renal artery stenosis, primary aldosteronism or pheochromocytoma)
- •Significant comorbidities (e.g., advanced malignancy, advanced liver disease) with a life expectancy of less than 1 year
- •Subject is expected to initiate dialysis within 6 months
- •Previous treatment on a drug being investigated for the treatment of FSGS
- •Known diagnosis of Human Immunodeficiency Virus, Hepatitis B, or Hepatitis C
- •Known history of a primary immunodeficiency or an underlying condition such as splenectomy that predisposes the subject to infections
- •Systemic hematologic disease (e.g., hematologic malignancy, sickle cell anemia, myelodysplastic syndrome)
- •Current malignancy or history of malignancy within 5 years of screening, with the exception of non-melanoma skin cancers and cervical intraepithelial neoplasia
- •Treatment for any malignancy (e.g., radiation, chemotherapy, hormone therapy, or biologics) within 5 years of screening, with the exception of locally excised non-melanoma skin cancer or cervical intraepithelial neoplasia
- •Pregnant or breast feeding, or might become pregnant during the study or within 4 weeks after the end of treatment
- •Female of reproductive potential not willing to use highly effective methods of birth control during treatment and for 4 weeks after the end of treatment
- •Currently receiving systemic antibiotics for treatment of an active infection; or history of frequent infections (more than one event per 6 months)
- •History of any organ transplant
- •Bipolar disorder, or Major Depressive Disorder characterized by severe depression requiring hospitalization, or history of suicidal ideation/attempts
- •Currently enrolled in another interventional study, or less than 4 weeks since ending another interventional study(s) or receiving investigational agents(s)
- •Subject has a disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with all required study procedures.
研究组 & 干预措施
Acthar 40 units
Other
Acthar 40 units subcutaneously three times a week for patients with sub-nephrotic proteinuria.
干预措施: Acthar (Drug)
Acthar 80 units
Other
Acthar 80 units subcutaneously twice a week for patients with nephrotic proteinuria.
干预措施: Acthar (Drug)
结局指标
主要结局
Change in proteinuria with H.C. Acthar gel
时间窗: End of treatment with H.C. Acthar gel (end of 6 months or 1 year of treatment)
Percent change in proteinuria at the end of Treatment period in patients with baseline sub-nephrotic proteinuria
Change in eGFR with H.C. Acthar gel
时间窗: End of treatment with H.C. Acthar gel (end of 6 months or 1 year of treatment)
Percent change in Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR at the end of Treatment period
次要结局
- Percent change in proteinuria(1 year and 2 years of study follow-up after treatment completion)
- Percent change in CKD-EPI eGFR(1 year and 2 years of study follow-up after treatment completion)
- Change in CKD-EPI eGFR(1 year and 2 years of study follow-up after treatment completion)
- Duration of remission after H.C. Acthar gel treatment(1 year and 2 years of study follow-up after treatment completion)
- Changes in kidney fibrosis after H.C. Acthar gel treatment(End of treatment with H.C. Acthar gel (end of 6 months or 1 year of treatment))
- Cholesterol and lipoprotein profile before and after treatment with H.C. Acthar gel(End of treatment with H.C. Acthar gel (end of 6 months or 1 year of treatment))
研究者
研究点 (1)
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