EUCTR2010-023471-26-PL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). - P-Monofer-CKD-03
适应症
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
- •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 9.5 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. Dose 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).
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •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
相似试验
已完成
3 期
Research Study to demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is non-inferior to oral iron sulphate in reducing renal related anemia in subjects with non-dialysis dependent chronic kidney disease (NDD-CKD), determined as ability to increase Hb.CTRI/2010/091/000417Pharmacosmos AS350
招募中
3 期
To demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is equivalent to IV iron sucrose determined as ability to maintain the iron level to certain limits in patients already on iron therapy with CKD-5D who are on maintenance iron therapyCTRI/2011/05/001740Lars Christensen MD351
进行中（未招募）
不适用
A Phase III study where Iron Isomaltoside 1000 (Monofer®) administered by infusions or repeated bolus injections is compared with Iron Sulphate taken by mouth in subjects with non-dialysis dependent chronic kidney disease and with renal-related anaemia.EUCTR2009-016728-29-DEPharmacosmos A/S350
进行中（未招募）
不适用
A study to compare Iron Isomaltoside 1000 (Monofer®), as single or repeated injections, with intravenous Iron Sucrose in subjects with Chronic Kidney Disease and who is on Dialysis Therapy (CKD-5D) and have reached stage 5 in their disease.Stage 5 Chronic Kidney DiseaseMedDRA version: 14.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2010-023471-26-SEPharmacosmos A/S351
进行中（未招募）
不适用
Et randomiseret, komparativt, ikke-blindt fase III-forsøg med intravenøst jernisomaltosid 1000 (Monofer®), indgivet som vedligeholdelsesbehandling med enkelte eller gentagne bolusinjektioner sammenlignet med intravenøst jernsukrose hos forsøgspersoner med kronisk nyresygdom i stadie 5, som er i dialyse.EUCTR2010-023471-26-DKPharmacosmos A/S350