Efficacy of Ferric Carboxymaltose Versus Iron Sucrose in Non-dialysis Dependent Chronic Kidney Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Change from baseline in hemoglobin concentration
研究概览
简要总结
The goal of this clinical trial is to learn if Ferric Carboxymaltose is a safe efficacious alternative to Iron Sucrose for treatment of Iron deficiency anemia in non-dialysis dependent chronic kidney disease patients. The main questions it aims to answer are:
- Does Ferric Carboxymaltose causes similar or higher rise in hemoglobin concentration and serum Ferritin and transferrin saturation
- What medical problems will participants have when receiving Ferric Carboxymaltose
Participants will:
- Be administered either Ferric Carboxymaltose or Iron Sucrose
- Visit the clinic at day 28 and 56 for checkup and tests
- Be monitored for any medical problem during and after infusion
详细描述
Anemia is a common complication of chronic kidney disease with its prevalence increasing with disease progression. The major causes of anemia in patients who have CKD are iron and erythropoietin deficiency. For management of iron deficiency either oral or intravenous iron products are used. Currently Iron Sucrose is being used as drug of choice for intravenous iron replacement for treatment of iron deficiency anemia as standard of care in Pakistan.
Objective of this study is to compare Ferric Carboxymaltose versus Iron Sucrose for treatment of iron deficiency anemia.
This study will be conducted at the department of Nephrology, Sindh Institute of Urology and Transplantation (SIUT), Karachi, Sindh, Pakistan. Data will be collected after taking approval of Institutional review board and Ethical review Committee and informed written consent from the participants.
Participants will be enrolled by principal investigator. All participants will be randomized into two groups by sealed envelopes.
After enrollment, participants will be administered either Ferric Carboxymaltose or Iron Sucrose at daycare clinic of department, Dose will be according to calculated iron deficit though Ganozi formula. Iron deficit(mg) = bodyweight(kg) x (target hemoglobin - actual hemoglobin ) (g/dl) x 2.4 + Iron storage depot(mg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients
- •Between age 18-85 years
- •Patients diagnosed with Chronic kidney disease having eGFR of less than 60 ml/kg/1.73m2 (not on maintenance dialysis)
排除标准
- •Patients on maintenance dialysis
- •Patients with concomitant B12 or folate deficiency
- •Patients receiving ESA therapy
- •Patients with prior Iron replacement therapy within preceding 2 weeks
- •Patients receiving blood transfusions within preceding 3 months
- •Pregnant Females
- •Patients with Upper GI Bleeding
- •Patients with history of hematologic disorders, active malignancy or chronic inflammatory conditions like tuberculosis or ulcerative colitis
研究组 & 干预措施
Ferric Carboxymltose (FCM)
Participants will receive intravenous Ferric Carboxymaltose according to their Iron deficit
干预措施: Ferric Carboxymaltose (FCM) (Drug)
Iron Sucrose (IS)
Participants will receive intravenous Iron Sucrose according to their Iron deficit
干预措施: Iron Sucrose injection (Drug)
结局指标
主要结局
Change from baseline in hemoglobin concentration
时间窗: Baseline, Day 28, Day 56
Change from baseline in Transferrin Saturation (TSAT)
时间窗: Baseline, Day 28, Day 56
Transferrin Saturation (TSAT) will be calculated as: TSAT (%) = 100 x Serum Iron/Total Iron binding capacity (TIBC)
Change from baseline in serum Ferritin
时间窗: Baseline, Day 28, Day 56
次要结局
- Safety, as measured by number of subjects with at least one adverse event(Baseline, Day 28, Day 56)
研究者
Kamlesh Kumar
FCPS Nephrology Resident
Sindh Institute of Urology and Transplantation