NCT07487727招募中3 期
A Phase 3, Multi-center, Randomized, Open-Label, Active-Controlled, Efficacy and Safety Study of AND017 to Treat Anemia in Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Evaluate the efficacy of AND017 compared with the active control in maintaining Hemoglobin (Hb) levels in patients with anemia due to CKD
研究概览
简要总结
This is a pilot phase III, randomized, open-label, active-controlled study to evaluate the safety and efficacy of AND017 in non-dialysis-dependent (NDD)-CKD 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
- None
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
- •A diagnosis of CKD confirmed at screening, KDOQI CKD stage 3, 4, or 5 defined by estimated Glomerular Filtration Rate (eGFR) using the CKD Epidemiology Collaboration (EPI) formula.
- •Not on dialysis and no clinical evidence of impending need to initiate dialysis during the study treatment.
- •Prior ESA and hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) treatment
- •ESA/HIF-PHI-naïve: Defined as no use of any ESA/HIF-PHI treatment for at least 12 weeks before randomization; Mean of the two most recent Hb values during the screening period obtained at least 7 days apart must be ≥7.5 g/dL and <10.0 g/dL with a difference of ≤1.3 g/dL between the two values;
- •ESA-treated: Defined as having received an approved ESA, administered intravenously or subcutaneously, for at least 6 weeks prior to randomization, with no change in ESA product and no treatment interruption exceeding 2 consecutive weeks; Mean of the two most recent Hb values during the screening period obtained at least 7 days apart must be 9.0-12.0 g/dL inclusive.
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3× upper limit of normal (ULN)
- •Transferrin saturation (TSAT) ≥20% or ferritin ≥100 ng/mL at screening test
- •Serum folate and vitamin B12 ≥ lower limit of normal (LLN) at screening test
排除标准
- •Concurrent retinal neovascular lesions requiring treatment.
- •Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis or concurrent autoimmune disease with inflammatory symptoms.
- •History of gastric/intestinal resection considered to affect the absorption of drugs in the gastrointestinal tract or concurrent symptomatic gastroparesis despite being on treatment.
- •Uncontrolled hypertension, defined as patients with hypertension having more than one of three systolic blood pressure >180 mmHg, or diastolic blood pressure >110 mmHg during the screening assessment
- •Concurrent congestive heart failure (New York Heart Association [NYHA] Class III or higher).
- •History of stroke, transient ischemic attack (TIA), myocardial infarction, thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or lung infarction within 24 weeks before the screening assessment.
- •Participants with a history of significant liver disease or active liver disease.
- •History of a seizure disorder or any occurrence of seizures in the past.
- •Serum albumin (ALB) < 2.5 g/dL at screening test.
- •Prior ESA/HIF-PHI treatment caused total bilirubin >1.5xULN, or AST/ALT/ALP>3xULN, or serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.).
- •Any prior functioning organ transplant or a scheduled organ transplantation, or anephric.
结局指标
主要结局
Evaluate the efficacy of AND017 compared with the active control in maintaining Hemoglobin (Hb) levels in patients with anemia due to CKD
时间窗: From Week 23 to Week 27
The mean Hb levels averaged over Week 23-27
次要结局
- The percentage of responders(From baseline to Week 27)
- Percentage of participants that maintained Hb level over target lower limit(From Week 5 to Week 27)
- Maintenance of Hb within 10.0-12.0 g/dL after initial achievement ≥10.0 g/dL during the entire study treatment period(From baseline to Week 53)
- Incidence of extreme Hb levels of ≥13.0 g/dL or <7.5 g/dL during the entire study treatment period(From baseline to Week 53)
- Incidence of excessive erythropoiesis(From baseline to Week 53)
- The cumulative incidence of Hb non-response(From baseline to Week 27)
- Mean Hb change from baseline averaged over Weeks 5-27(From baseline to Week 27)
- Mean Hb change from baseline averaged over Weeks 23-27(From baseline to Week 27)
- Mean Hb change from baseline averaged over Weeks 13-17(From baseline to Week 17)
- Mean Hb change from baseline averaged over Weeks 27-53(From baseline to Week 53)
- Mean Hb change from baseline averaged over Weeks 49-53(From baseline to Week 53)
- During the entire treatment period, mean Hb at each visit(From baseline to Week 53)
- The use of intravenous iron during the entire study treatment period(From baseline to Week 53)
- The mean weekly dose of intravenous iron during the entire treatment period(From baseline to Week 53)
- The time to first initiation of intravenous iron during the entire treatment period(From baseline to Week 53)
研究者
研究点 (1)
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