NCT04627181Unknown4 期
The Role Of IV Iron (Ferric Carboxymaltose) And IM Vitamin B12 (Hydroxycobalamin) Supplementation In The Management Of Anaemic Prevalent Indian Hemodialysis Patients: A Parallel Group, Quadruple Blind, Placebo-Controlled, Pragmatic Randomized Control Trial With 2x2 Factorial Design
Christian Medical College, Vellore, India1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年11月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean haemoglobin
研究概览
简要总结
A parallel group, quadruple blind, placebo-controlled, randomized control trial with 2x2 factorial design to determine the effect of simultaneous IV ferric carboxymaltose and IM hydroxycobalamin supplementation in anemic Indian HD patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult prevalent HD patients on HD for at least 3 months with hemoglobin < 11 g/dL
排除标准
- •Blood transfusion, blood loss, infection, surgery or change in haemoglobin by > 1 g/dL in the last 1 month
- •Hemoglobinopathy
- •Cirrhosis
- •Hematological malignancy or myeloproliferative disorder
- •HIV, HBV or HCV infection
- •Any chronic inflammatory disorder
- •IV iron or oral/IM B12 received in the last 3 months
- •Severe hyperparathyroidism (intact parathyroid hormone > 1,000 pg/mL)
- •Pregnancy
- •Age < 18 years
- •History of asthma or eczema, any history of drug allergy, including allergy to iron preparations
- •History of exposure to chemotherapy or cytotoxic drugs - 5-FU, hydroxyurea, hydroxycarbamide, methotrexate, trimethoprim, colchicine, azathioprine
- •History of G-CSF use in the last 1 month
- •General anaesthesia with nitrous oxide in the last 1 month
研究组 & 干预措施
B12 + placebo
Experimental
- Hydroxycobalamine: Single dose, 1000 mcg
- Placebo: Single dose
干预措施: Placebo (Drug)
FCM + placebo
Experimental
- Ferric carboxymaltose: Single dose, 500 mg
- Placebo: Single dose
干预措施: Ferric carboxymaltose (Drug)
FCM + placebo
Experimental
- Ferric carboxymaltose: Single dose, 500 mg
- Placebo: Single dose
干预措施: Placebo (Drug)
B12 + placebo
Experimental
- Hydroxycobalamine: Single dose, 1000 mcg
- Placebo: Single dose
干预措施: Hydroxycobalamin (Drug)
FCM +B12
Experimental
- Ferric carboxymaltose: Single dose, 500 mg
- Hydroxycobalamine: Single dose, 1000 mcg
干预措施: Ferric carboxymaltose (Drug)
FCM +B12
Experimental
- Ferric carboxymaltose: Single dose, 500 mg
- Hydroxycobalamine: Single dose, 1000 mcg
干预措施: Hydroxycobalamin (Drug)
Placebo + placebo
Placebo Comparator
- Placebo: Single dose
- Placebo: Single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Mean haemoglobin
时间窗: 30 days
Mean haemoglobin measured 30 days after the intervention
次要结局
- Sensitivity and specificity of baseline automated red cell indices, peripheral smear red cell indices, and iron indices for diagnosis of iron deficiency(Baseline)
- Optimum cutoff for baseline automated red cell indices for the diagnosis of iron deficiency anemia using ROC curve analysis(Baseline)
- Sensitivity and specificity of baseline peripheral blood smear hypochromia, peripheral blood smear anisocytosis and automated red cell indices for the diagnosis of iron deficiency anemia in participants with TSAT < 30% and TSAT > =30%.(Baseline)
- Sensitivity and specificity of baseline peripheral smear neutrophil hypersegmentation and cell population data for the diagnosis of B12 deficiency.(Baseline)
- Optimum cutoff of cell population data for the diagnosis of B12 deficiency using ROC curve analysis(Baseline)
- Adverse effects of IV ferric carboxymaltose and IM hydroxycobalamin therapy(Day 0)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant WomenAnaemiaNCT01131624Vifor Pharma252
撤回
4 期
Iron Substitution With Ferric Carboxymaltose as Treatment Strategy for Heart Failure Patients With Preserved Ejection FractionHeart Failure With Normal Ejection FractionIron-deficiencyNCT05477498Cantonal Hosptal, Baselland
进行中（未招募）
1 期
Effect of iron supplementation on symptoms of patient wit heart failure andiron deficiency.Patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency (ID) with and without anaemiaEUCTR2015-005757-12-DECharité – Universitätsmedizin Berlin200
招募中
4 期
Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTionMyocardial Infarction, AcuteNCT05759078Wroclaw Medical University1,000
终止
3 期
Effects of Oral Iron on Postoperative Fatigue Upon Coronary Artery Bypass Graft PatientsFatigueNCT01912261Nova Scotia Health Authority121