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临床试验 NCT07494409 针对Anemia Due to Chronic Kidney Disease目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia III期 300 随机化 开放性试验
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临床试验NCT07494409旨在研究治疗，主要针对Anemia Due to Chronic Kidney Disease。这是一项III期 干预性研究试验，目前试验状态为招募中。试验始于2025年10月31日，计划招募300名患者。该研究由Kind Pharmaceuticals LLC主导，预计于2027年4月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月27日。
简要概括
This is a phase III, randomized, open-label, active-controlled study to evaluate the safety and efficacy of AND017 in anemic patients with End-Stage-Kidney-Disease (ESKD)
官方标题
A Phase 3, Multi-center, Randomized, Open-Label, Active-Controlled, Efficacy and Safety Study of AND017 to Treat Anemia in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia
疾病
Anemia Due to Chronic Kidney Disease其他研究标识符
- AND017-CN-302
- CTR20253615 (其他标识符) (China National Medical Products Administration)
NCT编号
实际开始日期
2025-10-31
最近更新发布
2026-03-27
预计完成日期
2027-04-30
计划入组人数
300
研究类型
干预性研究
试验分期 (阶段)
III期
试验状态
招募中
关键词
anemia
CKD
ESKD
CKD
ESKD
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性AND017 | AND017 capsules AND017 capsules administered orally with a starting dose of 10 mg TIW |
阳性对照Erythropoiesis Stimulating Agents (ESA) | ESA ESA injection and dose based on package insert and local practice |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Evaluate the efficacy of AND017 compared with the active control in maintaining Hb levels in anemic patients with ESKD | The mean Hb levels averaged over Week 23-27 | From Week 23 to Week 27 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
The percentage of responders | Responder is defined as: for participants with baseline Hb ≥ 9.0 g/dL, mean Hb ≥10.0 g/dL and a change from baseline ≥ -1.0 g/dL during Weeks 23-27 | From baseline to Week 27 |
Percentage of participants that maintained Hb level over target lower limit | Percentage of participants with mean Hb ≥ 10.0 g/dL averaged over Weeks 5-27 | 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. | During entire study treatment period, the percentage of participants in which Hb, after first reaching ≥ 10.0 g/dL, is maintained within the target range of 10.0-12.0 g/dL (inclusive) | 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 | During the entire study treatment period, the percentage of participants in which Hb is ≥ 13.0 g/dL or \< 7.5 g/dL | From baseline to Week 53 |
Incidence of excessive erythropoiesis | During the entire study treatment period, the percentage of participants with an Hb increase ≥ 1.0 g/dL within any 2-week period and an Hb increase ≥ 2.0 g/dL within any 4-week period respectively | From baseline to Week 53 |
The cumulative incidence of Hb non-response | The cumulative incidence of Hb non-response is defined as Hb \< 10.0 g/dL and an increase from baseline \< 1.0 g/dL averaged over Weeks 5-27 | From baseline to Week 27 |
Mean Hb change from baseline averaged over Weeks 5-27 | 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 | 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 | 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 | 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 | Mean Hb change from baseline averaged over Weeks 49-53 | Mean Hb change from baseline averaged over Weeks 49-53 |
During the entire treatment period, mean Hb at each visit | 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 | The percentage of participants that have received 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 | 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 | The time to first initiation of intravenous iron during the entire treatment period | From baseline to Week 53 |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Receiving stable hemodialysis (including combination methods such as hemodiafiltration or hemofiltration), peritoneal dialysis for ESKD for a minimum of 16 weeks prior to randomization and determined by the Investigator to be compliant with dialysis treatment prescription.
- Patient must have been on IV or SC of an approved ESA under the prescription for at least 6 weeks
- The mean of two hemoglobin values during screening must be 9.0-12.0 g/dL.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)<3× upper limit of normal (ULN)
- Transferrin saturation ≥20% or ferritin ≥100 ng/mL at screening test
- Serum folate and vitamin B12 ≥ lower limit of normal (LLN) at screening test
- 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/hypoxia-inducible factor-prolyl hydroxylase inhibitor (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
Kind Pharmaceuticals LLC研究中心联系人
联系人: Yusha Zhu, MD, PhD, 6467252552, [email protected]
1 位于 1 个国家/地区的研究中心
Fudan Univeristy Zhongshan Hospital, Shanghai, 200032, China
Xiaoqiang Ding, 主要研究者
招募中