NCT05265325已完成2 期
A Phase 2, Multicenter, Open-label, Randomized, Active-Controlled Study of Efficacy and Safety of AND017 in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
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
- 175
- 试验地点
- 25
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This is a phase II study to evaluate the safety and efficacy of AND017 in renal anemia patients on dialysis
详细描述
This is a Phase II study to assess the safety and efficacy of AND017 in patients with CKD who are anemic and on dialysis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight from 45 to 140 kg inclusive
- •Receiving stable HD (including combination methods such as hemodiafiltration or hemofiltration), HHD, or PD 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, and ≤25% change in dose between the two most recent doses, prior to randomization.
- •The mean of two hemoglobin values during screening (at least 7 days apart) must be 9.0-11.0 g/dL with a difference of ≤1.3 g/dL between the two values
- •TSAT ≥ 20% or ferritin ≥ 100 ng/mL at screening
- •Folate ≥ 3.0 ng/mL and vitamin B12 ≥ lower limit of normal (LLN) at screening
- •AST and ALT < 3×ULN at screening.
- •No evidence of other causes of anemia caused by a pathologic process in the hematopoietic system, including intra- or extravascular hemolysis, or myelodysplasia.
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 determined by the Investigator to be caused by concurrent autoimmune disease with inflammatory symptoms (such as systemic erythematosus, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, Sjögren's syndrome, celiac disease, etc.).
- •History of gastric/intestinal resection considered influential on the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent symptomatic gastroparesis despite on treatment.
- •Clinically significant bleeding (eg, requiring transfusion or drop in Hb of ≥ 2 g/dL) within 4 weeks of first dose; 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 (TIA), myocardial infarction, thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or lung infarction within 24 weeks before the screening assessment.
- •Positive for hepatitis B surface antigen or anti-hepatitis C virus antibody at the screening assessment, or positive for human immunodeficiency virus in a past test.
- •Not complying with COVID-19 prevention and control requirements per local policy.
- •Concurrent primary form of anemia other than renal anemia (hemolytic anemia, thalassemia, sickle cell anemia, history of pure red cell aplasia, history of myelodysplastic syndrome or multiple myeloma, iron deficiency, etc.). Any question of the primary cause of anemia should be discussed with the Medical Monitor before the patient signs informed consent.
- •Known hemosiderosis, hemochromatosis or hyper-coagulable condition
- •Known to be hypersensitive or intolerant to ESA.
- •Having received treatment with androgenic anabolic steroids, testosterone enanthate, or mepitiostane within 5 weeks prior to the first dose.
- •Any treatment with a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) within 5 weeks prior to the first dose.
- •TBIL>1.5 ULN, or AST>3 ULN, or ALT>3 ULN, or ALP>3 ULN, or previous or concurrent serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.) thought to be caused by any other HIF-PHI.
- •Previous or current malignant tumor (patients with no recurrence for at least 5 years are eligible. Exemption: basal cell and squamous cell carcinoma not under active stage).
- •Patients with a history of significant liver disease or active liver disease.
- •Patients that have major surgery planned during the study period.
- •Patients that have undergone blood transfusion or with evidence of major blood loss within 8 weeks before the screening assessment. Investigators should discuss this with the Medical Monitor for cases where there is doubt about whether to exclude or not.
- •Patients unable to discontinue IV iron during the screening period.
- •Patients with an organ transplant on immunosuppression, or with a scheduled kidney or any other organ transplant within the duration of the study, or without kidney.
- •Serum albumin < 2.5 g/dL at screening.
- •Patients with other chronic medical condition that may limit life expectancy in the opinion of the Investigator.
- •History of a seizure disorder or any occurrence of seizures in the past.
研究组 & 干预措施
AND017 Dose Regimen A
Experimental
AND017 will be administrated orally at dose A three times a week
干预措施: AND017 capsules TIW (Drug)
AND017 Dose Regimen B
Experimental
AND017 will be administrated orally at dose B once a week
干预措施: AND017 capsules QW (Drug)
Erythropoietin stimulating agent
Active Comparator
Investigator will select an erythropoietin stimulating agent, such as epoetin alfa, darbepoetin alfa, Mircera®, or their biosimilars, for the patient under this arm with starting doses and dose adjustment rules according to the epoetin alfa USPI or SmPC.
干预措施: epoetin alfa, darbepoetin alfa, Mircera®, or their biosimilars (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 20 weeks
Incidence of adverse events
Mean change from baseline in Hb at Week 6
时间窗: Up to 5 weeks after dosing
Mean change from baseline in Hb at Week 6
次要结局
- Proportion of responders, during the entire study period.(up to Week 20)
- Mean proportion of visits at which patients maintain Hb within the target range from baseline during the fixed-dose period and titration period(up to Week 20)
- Proportion of patients with a mean Hb between 10.0-11.0 g/dL inclusive during Week 14-20(at Week 14, 15, 16, 17, 18, 19, and 20)
- Change in Hb from baseline to the mean Hb levels over Week 14-20(Baseline and at Week 14, 15, 16, 17, 18, 19, and 20)
- Mean Hb levels and mean change from baseline in Hb level at each visit(up to Week 20)
- Cumulative response rate over the entire study period(up to Week 20)
研究者
研究点 (25)
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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