EUCTR2010-023471-26-DK进行中（未招募）不适用
A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison with Intravenous Iron Sucrose in Subjects with Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 350
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
- •Subjects with a diagnosis of CKD-5D, in dialysis therapy for at least 90 days prior to inclusion, will be
- •included if they meet all of the following criteria:
- •1. Men or women, aged 18 years or greater.
- •2. Subjects diagnosed with CKD-5D and in haemodialysis therapy for at least 90 days.
- •3. Life expectancy beyond 12 months by Principal Investigator’s judgement.
- •4. Willingness and ability to participate after Informed Consent.
- •5. Hb concentrations between 10.0 g/dL and 12.5 g/dL (both values included) both at screening
- •Visit 1a and at Screening Visit 1b. (Screening Visit 1a and Visit 1b must be separated by at
- •least 1 week).
- •6. Serum ferritin < 800 ng/mL.
- •7. Transferrin Saturation < 35%.
- •8. Subjects receiving ESA treatment with dose stable for the previous 4 weeks prior to inclusion
- •(with only 1 missed dose to be allowed. Does to be kept stable during the study period).
- •9. Subjects receiving no IV iron or an average of no more than 100 mg/week for the previous 4
- •weeks (with only 1 missed dose to be allowed. Does to be kept stable during the study
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •1. Anaemia caused primarily by factors other than renal related anaemia.
- •2. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and
- •haemosiderosis).
- •3. Patients currently undergoing treatment with immunosuppresives (low dose steroids are
- •allowed during the study conduct for dosages no more than 10 mg prednisolone/day or
- •equivalent. If possible the dosage should be kept constant through the study).
- •4. Difference of Hb 1.0 g/dL between screening Visits 1a and 1b.
- •5. Patients with a history of multiple allergies.
- •6. Decompensated liver cirrhosis or active hepatitis [Alanine Aminotransferase (ALT) > 3 times
- •normal] or history of Hepatitis B or C.
- •7. Active acute or chronic infections (assessed by clinical judgement), supplied with White Blood
- •Cells (WBC) and C-Reactive Protein (CRP).
- •8. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
- •9. Pregnancy or nursing. (To avoid pregnancy, women have to be postmenopausal (at least 12
- •months must have elapsed since last menstruation), surgically sterile, or women of child
- •bearing potential must use one of the following contraceptives during the whole study period
- •and after the study has ended for at least 5 times plasma biological half-life of the
- •investigational medicinal product: Contraceptive pills, Intrauterine Devices (IUD),
- •contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal
- •ring, and transdermal patches).
- •10. Blood transfusion within the previous 12 weeks.
- •11. Planned elective surgery in the next 8 weeks.
- •12. Participation in any other clinical trial within the past 30 days, or if longer, where the study
- •drug has not passed five half-lives prior to screening.
- •13. Untreated Vitamin B12 or folate deficiency.
- •14. Any other medical condition that, in the opinion of Principal Investigator, may cause the
- •subject to be unsuitable for the completion of the study or place the subject at potential risk
- •from being in the study. Examples include Uncontrolled Hypertension, Unstable Ischemic
- •Heart Disease or Uncontrolled Diabetes Mellitus.
研究者
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A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison with Intravenous Iron Sucrose in Subjects with Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).Stage 5 Chronic Kidney Disease on Dialysis Threapy (CKD-5D)MedDRA version: 14.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857EUCTR2010-023471-26-PLPharmacosmos A/S350