NCT05629598招募中2 期
A Phase Ⅱ Clinical Study on the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Polyethylene Glycol Recombinant Human Erythropoietin Injection (CHO Cell) in Optimal Dose and Administration Regimen for Maintenance Therapy in Patients With Regular Dialysis Renal Anemia.
Angde Biotech Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年4月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change of mean hemoglobin during dose adjustment period
研究概览
简要总结
The purpose of the study is to explore the optimal dose and administration of the experimental drug, and to evaluate the safety and efficacy of the drug in patients with renal anemia. Patients with renal anemia on regular dialysis treatment are expected to be enrolled in this study.
详细描述
This study is a multi-center, randomized, open-label, positive controlled phase II clinical study. A total of 125 to 150 patients with renal anemia receiving regular dialysis were enrolled in this study. Those patients were randomly allocated to 5 treatment groups in a ratio of 1:1:1:1:1, with 25 to 30 patients in each group.
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
- •Male and female patients at the age of 18~75 (including critical value).
- •Patients clinically diagnosed with renal anemia who have received dialysis for at least 12 weeks (hemodialysis≥3 times/week, total urea clearance index (Kt/V) ≥1.2 or urea reduction rate (URR) ≥65%; peritoneal dialysis≥4 times/day, weekly Kt/V≥1.7);
- •Hb in screening period should be within the range of 100~130g/L (including both ends), and the deviation should not exceed 10g/L;
- •Iron status (TSAT ≥20% or SF ferritin ≥100μg/L) during screening.
- •Have been stably treated with short-acting EPO 1-3 times per week for at least 12 weeks before baseline;
- •Consent to use reliable contraceptive methods and no family planning from the screening period to 3 months after the last administration；
- •Voluntarily participate in the trial and sign the informed consent form.
排除标准
- •1. Patients with a history of severe allergies (including drug allergies), especially allergic to erythropoietin, or to any component of the test drug (e.g. polyethylene glycol);
- •2. Have a history of kidney transplantation or plan to undergo kidney transplantation during the trial；
- •3. Have any other disease that causes chronic anemia (e.g., sickle cell anemia, myelodysplastic syndrome, hematologic malignancy, myeloma, hemolytic anemia, pure red cell aplastic anemia) or PRCA following therapy of erythropoietin protein;
- •4. Suffered from acute or chronic blood loss (such as gastrointestinal bleeding) or undergwent surgical procedures due to massive bleeding within 3 months before screening, or plan to have a surgery during the clinical trial (except for arteriovenous fistula or peritoneal dialysis tube adjustment);
- •5. Have a history of malignant tumors within the past 5 years (excluding non-melanoma skin cancer or excised carcinoma in situ);
- •6. Suffer from autoimmune diseases (such as rheumatoid arthritis or systemic lupus erythematosus) or diseases of endocrine system (such as poorly controlled diabetes mellitus complicated with peripheral vascular diseases, severe secondary hyperparathyroidism \[parathyroid hormone \> 800ng/L\]);
- •7. Received systemic antibiotic treatment or C-reactive protein ≥30mg/L within 4 weeks due to severe infection before screening;
- •8. The following conditions occur during screening period:
- •Hepatic dysfunction (AST or ALT\>3 times ULN); Coagulation dysfunction (activated partial thrombin time \> 1.5 times ULN); Folic acid or vitamin B12 deficiency (serum folic acid level \ 170mmHg or DBP ≥100mmHg) or hypotension (SBP before dialysis \<90mmHg);
- •10. Suffer from severe cardiovascular and cerebrovascular disease, severe or unstable coronary artery disease, heart failure (NYHA CLASS III or IV), or those who received coronary artery bypass grafting or percutaneous coronary intervention within 6 months, or those who had a history of myocardial infarction or stroke within 3 months;
- •11. Received androgen therapy or blood transfusion within 8 weeks before screening period;
- •12. Received long-acting ESAs within 3 months or HIF-PHI (e.g., rosalat) within 2 weeks before initial administration;
- •13. Participated in other clinical trials as a subject within 4 weeks before screening period or the duration from the last administration to enrollment was shorter than the 5 half-lives of the drug;
- •14. Have a history of epileptic seizures or mental illness;
- •15. Alcoholism, drug abuse or drug addiction
- •16. Pregnant or breastfeeding;
- •17. Investigator considers not suitable to enter this trial.
结局指标
主要结局
Change of mean hemoglobin during dose adjustment period
时间窗: Day85-Day126
Change of mean hemoglobin compared to baseline from week 13 to 18 during dose adjustment period (dose adjustment period: week 7 to week 18/week 20).
Change of mean hemoglobin compared to baseline during fixed treatment
时间窗: Day1-Day42
Change of mean hemoglobin (Hb) content from baseline during fixed treatment (fixed treatment：week 1 to week 6)
次要结局
- Proportion of patients receiving red blood cell transfusion and number of transfusions during the trial.(Day1-Day126/140)
- Cmax(Day1-Day126/140)
- Tmax(Day1-Day126/140)
- AUC 0-t(Day1-Day126/140)
- Emax(Day1-Day126/140)
- Reticulocyte count, Hematocrit, Erythrocyte count(Day1-Day42、Day85-Day126)
- The number and proportion of patients with dose adjustments during the trial(Day1-Day126/140)
- Anti-drug antibody(1,5, 9, 13, 17 weeks (before administration) and 28±2 days after the last administration (A2/B2group ,A1/B1 patients with intensive blood collection) or 14±2 days after the last administration (A1/B1 patients with sparse blood collection))
- Tmax of Emax(Day1-Day126/140)
- Proportion of patients with hemoglobin keeping within the target range(Day1-Day42、Day85-Day126)
- Adverse events(Day1-Day126/140)
- AUC 0-∞(Day1-Day126/140)
- Number of iron deficiency, number of patients and proportion of patients with iron deficiency during the trial(Day1-Day126/140)
- AUE0-t(Day1-Day126/140)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant TumorsOvarian CancerCervical CancerNCT06769152Shanghai Henlius Biotech190
招募中
2 期
A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard TherapyEsophageal CancerNCT06769113Shanghai Henlius Biotech102
已完成
1 期
A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in Participants With Hematologic MalignanciesHematologic NeoplasmsNCT02329847Janssen Research & Development, LLC144
已完成
1 期
A Study of FORE8394 as a Single Agent in Patients With Advanced Unresectable Solid TumorsAdvanced Unresectable Solid TumorsBRAF-mutated TumorsNCT02428712Fore Biotherapeutics113
已完成
2 期
Safety, Efficacy and Pharmacokinetics of OPC-67683 in Patients With Pulmonary TuberculosisPulmonary TuberculosisNCT00401271Otsuka Frankfurt Research Institute GmbH54