EUCTR2006-002815-28-GB进行中（未招募）1 期
A Phase 2, Open-label, Multi-Center, Dose Finding Study of the Safety, Pharmacodynamics, and Pharmacokinetics of AF37702 Injection (HematideTM) for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •a. Patient is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local, and national guidelines
- •b. Males or females = 18 years of age. Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 4 weeks prior to study start, and must be willing to continue contraception until at least 4 weeks after the last dose of study drug
- •c. Clinically stable on hemodialysis for = 3 months prior to study start
- •d. Epoetin (alfa or beta) maintenance therapy, = 50 and = 200 U/kg/wk, at the same dosing frequency, continuously prescribed for 8 weeks prior to study start
- •e. Three mid- or end-of-week Hgb values of = 10.0 and = 12.5 g/dL in the 4 weeks prior to study start, with = 1.2 g/dL difference between any of the three values
- •f. One TSAT > 20% within 4 weeks prior to study start
- •g. One ferritin level = 100 ng/mL within 4 weeks prior to study start
- •h. One serum or red cell folate level = lower limit of normal during the 4 weeks prior to study start
- •i. One vitamin B12 level = lower limit of normal during the 4 weeks prior to study start
- •j. One C-reactive protein (CRP) level = 30 mg/L within 4 weeks prior to study start
- •k. Urea clearance/volume (Kt/V) = 1.2 within 4 weeks prior to study start
- •l. One white blood cell count (WBC) = 3.0 x 109/L within 4 weeks prior to study start
- •m. One platelet count = 100 x 109/L and = 500 x 109/L within 4 weeks prior to study start
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a. Pregnant or breast-feeding patients
- •b. Known intolerance to any erythropoiesis stimulating agent, parenteral iron
- •supplementation or PEGylated molecules
- •c. History of antibodies to any erythropoiesis stimulating agent or history of pure red cell aplasia (PRCA)
- •d. Known bleeding or coagulation disorder
- •e. Known hematologic disease (e.g., homozygous sickle-cell disease, thalassemia of all types, multiple myeloma, hemolytic anemia)
- •f. Uncontrolled or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.)
- •g. Known history of seizure disorder or received anti-epileptic medication within the
- •previous 6 months
- •h. Uncontrolled or symptomatic secondary hyperparathyroidism, per Investigator’s
- •clinical judgment
- •i. Poorly controlled hypertension within 4 weeks prior to study start, per Investigator’s clinical judgment
- •j. Chronic congestive heart failure of New York Heart Association class III or IV
- •k. High likelihood of early withdrawal or interruption of the study (e.g., myocardial
- •infarction, severe or unstable coronary artery disease, stroke, respiratory, autoimmune, neuropsychiatric, or neurological abnormalities, liver disease including active hepatitis B or C, active HIV disease, or any other clinically significant medical diseases or conditions in the prior 6 months that may, in the Investigator’s opinion, interfere with safety, assessment, or follow-up of the patient)
- •l. Evidence of malignancy within the past 5 years (except non-melanoma skin cancer
- •which is not an exclusion criterion)
- •m. Life expectancy < 12 months
- •n. Temporary (untunneled) dialysis access catheter
- •o. Anticipated elective surgery during the study period, that may be expected to lead to significant blood loss, including vascular access surgery such as an arteriovenous fistula or graft, or a scheduled kidney transplant
- •p. RBC or whole blood transfusion within 12 weeks prior to study start
- •q. Received antibiotics for systemic infection within 2 weeks prior to study start
- •r. Previous exposure to any investigational agent within 6 weeks prior to study start, or planned receipt of an investigational agent, other than as specified by this protocol, during the study period
研究者
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