EUCTR2005-004944-30-DE进行中（未招募）1 期
An Open-Label Study to Investigate the Efficacy and Safety of AF37702 Injection (Hematide™) in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients with Chronic Kidney Disease - AFX01-06
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- 性别
- All
入选标准
- •Patients who have confirmed antibody-mediated PRCA are potentially eligible for enrollment into this study. The following criteria must be documented in the patient's medical record at the time of diagnosis of PRCA:
- •i. Treatment with an ESA (e.g., epoetin or darbepoetin) with either a hemoglobin decrease while receiving a stable or increased dose of an ESA or requirement for blood transfusions
- •ii. Reticulocytes < 30,000 / mm3
- •iii. Bone marrow examination showing changes consistent with PRCA (i.e. markedly
- •decreased erythroid precursors in an otherwise normal marrow) or bone marrow
- •showing a normal number of erythroblasts without any excess blasts (e.g., less than
- •5%) and or any dysplastic features of the myeloid, erythroid or megakaryocytic
- •iv. Demonstration of anti-EPO antibodies
- •- Patients must be = 18 years old at the time of consent.
- •- ESAs must be discontinued for a minimum of 1 months prior to screening and enrollment into the study.
- •- Periodic transfusions are required to maintain the hemoglobin.
- •- Hemoglobin < 10 g/dL for at least 2 measurements, obtained at least 1 week apart or the patient has received a transfusion within the past 4 week to achieve a hemoglobin > 10 g/dL (without ESA therapy).
- •- Anti-EPO antibody confirmed by the central reference laboratory for this study (Professor Casadevall, Service d'Hematologie Biologique, Hopital Hotel-Dieu, Paris, France) within 1 month prior to baseline.
- •- Patients can either be chronic kidney disease (CKD) patients not yet requiring renal replacement therapy (patients not on dialysis), those on regular hemodialysis or peritoneal dialysis, or following a renal transplant.
- •- Patients may or may not have previously been treated with immunosuppressive therapy. Except for patients with a renal transplant, immunosuppressive therapy should be stopped at least 4 weeks before commencement of the study; patients with a renal transplant will be allowed to remain on a stable maintenance immunosuppressive regimen.
- •- 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 throughout the study until at least 4 weeks prior to study start and must be willing to continue practicing birth control for at least 4 weeks after the last dose of study drug. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence (only acceptable if practiced as a life-style and not acceptable if one who is sexually active practices abstinence only for the duration of the study) or vasectomized partner.
- •- Written informed consent must be obtained.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Patients already successfully re-challenged with another erythropoietic agent.
- •- Abnormal bone marrow findings consistent with the diagnosis of myelodysplasia, a myeloproliferative disorder, hematologic malignancy (e.g., acute or chronic leukemia) or evidence of metastatic infiltration.
- •- Poorly controlled hypertension within 4 weeks prior to study drug administration, per investigator’s clinical judgment, e.g., systolic = 170 mm Hg, diastolic = 100 mm Hg on repeat readings.
- •- Previous exposure to any investigational agent within 4 weeks prior to administration of study drug or planned receipt during the study period.
- •- High likelihood of early withdrawal or interruption of the study (e.g., myocardial infarction, severe or unstable coronary artery disease, stroke, severe or unstable respiratory, liver or neuropsychiatric disease , or other clinically significant medical diseases or conditions within the prior 6 months that may, in the investigator’s opinion, interfere with safety, assessment or follow-up of the patient).
- •- Patients who refuse to give informed consent.
- •- Women who are pregnant, lactating or not using a medically approved birth control (e.g., barrier or hormonal contraception).
- •- Life expectancy < 12 months.
研究者
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