NCT01599507已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Sequential Group, Dose Ranging Safety and Efficacy Study of FG 4592 in Non-dialysis Chronic Kidney Disease (CKD) Subjects With Anemia
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- FibroGen
- 入组人数
- 91
- 试验地点
- 13
- 主要终点
- Maximum change in hemoglobin by Week 9 from baseline
研究概览
简要总结
The primary purpose of this study is to evaluate efficacy and safety of FG-4592 in the correction of anemia in non-dialysis chronic kidney disease patients.
详细描述
Dose ranging study with two consecutive dose escalation cohorts. The study objective is to demonstrate that FG-4592 is effective in the correction of anemia in chronic kidney disease patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years
- •Subject has voluntarily signed and dated an informed consent form
- •Chronic Kidney Disease, not receiving dialysis
- •Hemoglobin (Hb) values in 4 screening visits and the mean Hb must be <10g/dL
- •Aminotransferase levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) and total bilirubin must be ≤ upper limit of normal (ULN) during the screening period
- •Serum alkaline phosphatase (ALP) ≤2x ULN during screening period. Subjects with serum ALP values between 1 x and 2 x ULN may be included only if bone-specific ALP (BSAP) is also elevated > ULN
- •Total bilirubin values must be ≤ULN during screening period
- •Serum folate and vitamin B12 levels above the lower limit of normal (LLN)
- •Body weight: 40 to 100 kg (dry weight) inclusive
- •Body mass index (BMI): 16 to 38 kg/m2 inclusive
排除标准
- •Received any erythropoiesis-stimulating agent (ESA) other than epoetin alfa within 12 weeks prior to Day 1
- •Any clinically significant infection or evidence of an underlying infection such as a white blood cell count (WBC) > ULN during screening on two separate occasions,
- •Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); anti-hepatitis C virus antibody (anti-HCV Ab)
- •History of chronic liver disease
- •New York Heart Association Class III or IV congestive heart failure
- •Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
- •Active or chronic gastrointestinal bleeding, or a known coagulation disorder
- •Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.)
- •Hematological disorders, including myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
- •History of hemosiderosis, hemochromatosis, polycystic kidney disease, or anephric
- •Active hemolysis or diagnosis of hemolytic syndrome
- •Known bone marrow fibrosis
- •Uncontrolled or symptomatic secondary hyperparathyroidism (PTH>600ng/L)
- •Any prior organ transplantation
- •Drug-treated gastroparesis, short-bowel syndrome, or any other gastrointestinal condition that may lead to reduced absorption of study drug
- •Serum albumin <3 g/dL
- •History of alcohol or drug abuse; or a positive drug screen for a substance that has not been prescribed for the subject
- •Prior treatment with FG-4592
- •Use of an investigational medication or treatment, or carryover effect of an investigational treatment expected, during the screening visit, treatment and follow-up period.
- •Use of traditional Chinese medicines (TCM) during the screening visit to Day 1 or plans to use TCM during the study unless approved in advance by the Medical Monitor
研究组 & 干预措施
FG-4592
Experimental
Active Drug
干预措施: FG-4592 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum change in hemoglobin by Week 9 from baseline
时间窗: Week 9
次要结局
- Proportion of subjects achieving a target Hb level ≥11 g/dL by Weeks 5,6,7,8 and 9.(Week 9)
- Proportion of subjects with a Hb increase from baseline ≥1.0 g/dL.(Week 9)
研究者
研究点 (13)
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