EUCTR2019-003140-71-DE进行中（未招募）1 期
Hemoglobin maintenance in pediatric ESRD patients by ferric pyrophosphate citrate (FPC)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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 must meet all of the following criteria to be eligible for inclusion in the study:
- •1. Parents/legal guardians of the patient have the ability to understand the requirements of the study and have demonstrated a willingness to have their child comply with all study procedures by signing an institutional review board-approved informed consent form. Where applicable, assent of the patient has also been obtained for all study procedures prior to any study-related activities.
- •2. Patient is between 6 months and <18 years of age at screening.
- •3. Patient has chronic kidney disease receiving in-center hemodialysis or hemodiafiltration (HDF) at least twice weekly for at least 3 months prior to screening.
- •4. Patient is receiving adequate hemodialysis as assessed by the investigator and based on a single pool Kt/V measurement >1.2.
- •5. Patient has a vascular access (tunneled catheter, AV fistula or AV graft) suitable to support blood flows for hemodialysis treatment.
- •6. Patient has a body mass of =11 lbs (5 kg).
- •7. Patient is iron-replete as measured by a TSAT = 20% and a ferritin >100 µg/L at screening.
- •8. Patient has a whole blood Hgb concentration of = 9.5 g/dL at. screening.
- •9. If the patient is female, she must be pre-pubertal, have had documented surgical sterilization prior to Baseline admission, or be practicing adequate birth control. All female patients who have reached menarche must have a negative serum pregnancy test during screening. It is the investigator’s responsibility to determine whether the patient has adequate birth control for study participation.
- •10. Patients who have experienced a previous adverse event with IV iron products are eligible to participate in this study if the agent that caused the event is not administered during the Baseline period.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A patient will not be eligible for inclusion in the study if any of the following criteria apply:
- •1. Patient is positive for human immunodeficiency virus (HIV) or hepatitis B by history.
- •2. Patient is receiving intravenous or oral antibiotics or antifungals for any infectious process. (Prophylactic antibiotics administered on a regular basis are allowed. Patients may enter the study once the infection has cleared.)
- •3. Patient has evidence of an ongoing active inflammatory process (e.g., systemic lupus erythematosus, acute or chronic active hepatitis, etc.) requiring treatment.
- •4. Patient has been dosed in an investigational drug study within the 30 days prior to Baseline.
- •5. Administration of iron containing phosphate binder ferric citrate (Aurixia®) or sucroferric oxyhydide (Velphoro®) within 2 weeks prior to Baseline. (Patient is only eligible if iron based binders are stopped at least 2 weeks prior to Baseline).
研究者
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