NCT05035641已完成2 期
A Pilot Phase II Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral AND017 to Treat Anemia in Nondialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 8
- 主要终点
- Rate of rise in hemoglobin for each of 3 dose levels as compared with placebo from baseline to 5 weeks after TIW oral dosing
研究概览
简要总结
This is a pilot phase II study to evaluate the safety and efficacy of AND017 in NDD-CKD patients
详细描述
This is a pilot phase 2, multicenter, randomized, parallel-group, double-blind, placebo-controlled, dose-ranging, safety and efficacy study of oral AND017 to treat anemia in non-dialysis-dependent 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic kidney disease, not receiving dialysis, with an eGFR <60 mL/min/1.73 m
- •Baseline Hb level ≥ 7.5 g/dL and <10.0 g/dL.
- •TSAT ≥ 20% or ferritin ≥ 100 ng/mL at screening test
- •Serum folate and vitamin B12 ≥ lower limit of normal at screening test
- •AST and ALT ≤ 3×ULN.
- •Total bilirubin ≤ 1.5×ULN.
排除标准
- •Concurrent retinal neovascular lesions requiring treatment including proliferative diabetic retinopathy, exudative age-related macular degeneration, retinal vein occlusion, macular edema, etc.
- •Anemia that is possibly mainly caused by concurrent autoimmune disease with inflammatory symptoms
- •History of gastric/intestinal resection considered to affect the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent symptomatic gastroparesis despite being on treatment.
- •Clinically significant bleeding (eg, requiring transfusion or drop in Hb of ≥ 2g/dL) within 4 weeks of first dose; no bleeding diathesis or risk of bleeding that has not been medically or surgically corrected at least 4 weeks prior to first dose of study drug.
- •Uncontrolled hypertension defined as patients with hypertension having more than one of three diastolic blood pressure values >95 mmHg and each test at least 5 min apart during the screening assessment.
- •Concurrent congestive heart failure (New York Heart Association [NYHA] Class III or higher).
- •History of stroke, transient ischemic attack, myocardial infarction, thromboembolic event, pulmonary embolism, or lung infarction within 24 weeks before the screening assessment.
- •Concurrent anemia due to another cause other than renal anemia
- •Known hemosiderosis, hemochromatosis or hyper-coagulable condition
- •Any treatment with a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) within 5 weeks before randomization.
- •Having received treatment with erythropoiesis stimulating agents, androgenic anabolic steroids, testosterone enanthate, or mepitiostane within 5 weeks before the first dose.
- •Total bilirubin >1.5xULN, or AST>3xULN, or ALT>3xULN, or ALP>3xULN, or previous or concurrent serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.) thought to be caused by ESAs.
- •Patients with a history of significant liver disease or active liver disease. Investigators should discuss this with the Medical Monitor for cases where there is doubt about whether to exclude or not.
- •Patients that have major surgery planned during the study period.
- •Having undergone blood transfusion and/or a surgical procedure within 8 weeks before the screening assessment.
- •Having undergone a kidney transplantation.
- •History of a seizure disorder or any occurrence of seizures in the past
研究组 & 干预措施
AND017 Dose C
Experimental
AND017 will be administrated orally at dose C
干预措施: AND017 (Drug)
Placebo
Placebo Comparator
Placebo will be administrated orally
干预措施: Placebo (Drug)
AND017 Dose A
Experimental
AND017 will be administrated orally at dose A
干预措施: AND017 (Drug)
AND017 Dose B
Experimental
AND017 will be administrated orally at dose B
干预措施: AND017 (Drug)
结局指标
主要结局
Rate of rise in hemoglobin for each of 3 dose levels as compared with placebo from baseline to 5 weeks after TIW oral dosing
时间窗: Up to 5 weeks after dosing
Calculate the slope of a linear regression for each patient using all hemoglobin data collected during the Fixed-Dose Period
Safety Evaluations
时间窗: Up to 17 weeks
Incidence of adverse events
次要结局
- Change from baseline in Hb(Up to 13 weeks after dosing)
- To assess iron utilization parameter during treatment - total iron-binding capacity (TIBC)(Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose)
- To assess iron utilization parameter during treatment - transferrin level(Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose)
- Hb response to treatment during Period 1(Up to 5 weeks after dosing)
- Percentage of responder patients(Up to 13 weeks after dosing)
- Change in hemoglobin levels from baseline to the mean of weeks 10-13(Baseline and at Week 10, 11, 12, 13, and 14)
- To assess changes in the levels of PD indicator - EPO(Baseline and at Week 2, 4, 6, 8, 10, 12, 14, and 28 days after the last dose)
- To assess changes in the levels of PD indicator - hepcidin(Baseline and at Week 2, 4, 6, 8, 10, 12, 14, and 28 days after the last dose)
- To assess iron utilization parameters during treatment - serum iron(Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose)
- Percentage of visits at which patients maintain hemoglobin between 10.0-11.0 g/dL after achieving hemoglobin ≥10.0 g/dL(Up to 13 weeks after dosing)
- Percentage of patients who maintain hemoglobin between 10.0-11.0g/dL at each visit(Up to 13 weeks after dosing)
- Mean Hb levels at weeks 6-14 including the average of weeks 10-13(Up to 13 weeks after dosing)
- Cumulative incidence of lack of response over the entire treatment period(Up to13 weeks after dosing)
- To assess iron utilization parameter during treatment - transferrin saturation (TSAT)(Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose)
- To assess iron utilization parameters during treatment - ferritin(Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose)
研究者
研究点 (8)
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相关资讯
AND017 Receives FDA Orphan Drug Designation for Sickle Cell Disease- Kind Pharmaceuticals' AND017, an oral small molecule, has been granted orphan drug status by the FDA for the treatment of sickle cell disease (SCD).
- The designation provides incentives, including tax credits and market exclusivity, to encourage the development of treatments for rare diseases like SCD.
- AND017 inhibits hypoxia-inducible factor prolyl hydroxylase (HIF-PH), stimulating red blood cell production and potentially improving safety and efficacy over existing treatments.
- Phase 1 and 2 studies have demonstrated AND017's safe and predictable behavior, with ongoing trials exploring its efficacy in SCD and other conditions.last yearFDA Grants Orphan Drug Designation to AND017 for Sickle Cell Disease- The FDA has granted Orphan Drug Designation to AND017, a novel hemoglobin-elevating agent developed by Kind Pharmaceutical, for the treatment of sickle cell disease (SCD).
- AND017 targets multiple stages of the red blood cell life cycle and is being developed for various anemia indications, including those associated with chronic kidney disease and myelodysplastic syndromes.
- Clinical trial data presented at ASN Kidney Week 2024 demonstrated the safety and efficacy of AND017 in treating anemia in both non-dialysis-dependent and dialysis-dependent chronic kidney disease patients.
- AND017 represents a potential new oral treatment option for SCD with a unique mechanism of action and a promising safety profile, according to researchers.last year