A COMPARATIVE STUDY OF PROACTIVE VERSUS REACTIVE APPROACH TO IV IRON THERAPY IN PATIENTS ON MAINTENANCE DIALYSIS
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the incidence of fatigue & Quality of life index at the end of 6 months between the two groups
研究概览
简要总结
After taking clearance from ethical committee of the institute, study will be conducted in the Department of MEDICINE, Command Hospital (EC). This will be a Randomized Clinical Trial. All eligible patients of Chronic Kidney Disease on Dialysis admitted in CHEC KOLKATA who meet the inclusion criteria will be included in the study after taking a written informed consent.
Enrolment, randomization and intervention - At enrolment, subjects will enter 2 weeks run-in period. Thereafter at baseline visit, subjects shall be randomized {allocation ratio 1:1} to receive Intravenous iron supplementation with iron isomaltoside (500 mg) once monthly to Proactive Group or 0 to1500mg once monthly as per requirement (15 mg/kg body weight) for correction of iron deficiency in reactive Group. In Proactive Group intravenous iron isomaltoside given to maintain serum ferritin level of >700mcg/l and transferrin saturation > 40% and in Low dose group (Reactive Group) intravenous ferric carboxy maltose is given if serum ferritin is <200mcg/l and transferrin saturation 20%. Blood samples (whole blood, plasma & serum) would be stored for biomarker analysis at baseline visit as per case record form.
Follow up visits - The subjects will be followed up monthly for 6 months after baseline visit. At these visits, Blood samples taken for Iron profile, complete blood count, renal function test, liver function test. And possible drug related side effects. In addition, information about general health and drug related side effects was sought at every months after baseline visit through telephonic interview. Subjects would be encouraged to report any change in their health status till 1 month after completion of study period. Every adverse event (major or minor) would be recorded. Blood samples (whole blood, plasma and serum) would be taken and preserved for subsequent analysis as per case record form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •CKD patients on Maintenance dialysis (hemodialysis or peritoneal dialysis) Age more than 18 years, Duration of Maintenance Dialysis more than 60 days, Hemoglobin less than 11g/dl, Ferritin < 400 µg/l and TSAT < 30% Follow up in Command Hospital, Eastern Command, Kolkata during study period.
排除标准
- •Current use of IV Iron therapy or Use of IV or Oral Iron Therapy within last 15days Blood Transfusion in last one month Active infection (bacterial, fungal) Known HIV or Hepatitis B or C Known / suspected diagnosis of autoimmune disease Past or present diagnosis of malignancy Known diagnosis of chronic liver disease History of any bleeding diathesis History of gastro-intestinal surgery in past 3 months Present or past diagnosis of peptic ulcer disease or gastro-intestinal bleeding History of severe allergic reactions to any form of intravenous iron preparations Pregnancy or lactation, in case of females Life expectancy < 1 year History of acquired iron overload Presence of Macrocytic anemia or Low Vitamin B12 level Patient not giving consent.
结局指标
主要结局
To compare the incidence of fatigue & Quality of life index at the end of 6 months between the two groups
时间窗: At the end of 6 months
次要结局
- To compare the incidence of Major Cardiovascular Adverse Events (Non fatal stroke, Non Fatal Myocardial infarction & cardiovascular death)(After 6 months)
- To compare the dose of Erythropoietin Stimulating agents & incidence of serious infections between the two groups(After 6 months)