Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Exercise tolerance
研究概览
简要总结
Iron deficiency is common in kidney transplant recipients and is associated with impaired exercise tolerance and an unfavourable prognosis.
This multicentre double-blind, placebo-controlled randomized controlled clinical trial will allow the investigators to analyse the effects of intravenous iron correction with ferric(III) carboxymaltose on exercise tolerance and other parameters, in comparison to a placebo.
详细描述
Rationale: Iron deficiency is common in kidney transplant recipients. The presence of iron deficiency is associated with an unfavourable prognosis in these patients. In patients with heart failure and iron deficiency, treatment with intravenous iron improved exercise capacity and quality of life. Whether such beneficial effects may also occur in kidney transplant recipients is unknown.
Objective: Our main objective is to address whether correction of iron deficiency with ferric(III) carboxymaltose improves exercise tolerance and quality of life in iron-deficient kidney-transplant recipients.
Study design: A multicentre double-blind, placebo-controlled randomized controlled clinical trial will be performed to compare the effects of ferric(III) carboxymaltose with placebo.
Study population: 158 iron-deficient kidney transplant recipients. The intervention arm will receive 10 mL of ferric(III) carboxymaltose (50 mg Fe3/mL, intravenously) every six weeks, with a total of four dosages. The control arm receives an intravenous placebo solution (saline).
Main study parameters/endpoints: The primary endpoint is the distance walked in six minutes, as quantified by the six-minute-walking-test at the end of follow-up.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All participants, care providers and researchers will be blinded, except for the nurse who will administer the medication.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant recipient
- •Iron deficiency, defined by a ferritin level of ≤100 ug/L, or 100-299 ug/L combined with a transferrin saturation of ≤20%
- •At least six months after transplantation at baseline
- •Age ≥18 years
- •Ability to comply with the study protocol
- •Informed consent
排除标准
- •Intolerance to any intravenous iron solution
- •Severe anemia (Hb <10.5 g/dL, <6.5 mmol/L), microcytic anemia (MCV <80 fl) or progressive anemia (˃3.2 g/dL per month decline for two months or more)
- •A positive feces occult blood test or otherwise demonstrated gastrointestinal, or urogenital, blood loss
- •Blood transfusion in the past six weeks
- •Polycythemia (Hb >15.3 g/dL, 9.5 mmol/L)
- •Estimated glomerular filtration rate (eGFR) of ≤ 30 ml/min per 1.73 m2
- •History of haemochromatosis
- •Unstable angina or myocardial infarction during the previous month
- •Disability to walk
- •Severe hypophosphatemia in the month before baseline (serum phosphate <0.35 mmol/L)
- •Pregnancy or inability to take adequate contraceptive measures when at childbearing age (women)
- •Any signs of an active systemic infection
- •Participation in another interventional study
研究组 & 干预措施
Ferric(III) carboxymaltose
The intervention group will be treated with four dosages of 500 mg iron in the form of 10 mL ferric(III) carboxymaltose dissolved in 240 mL of NaCl 0.9%, with interval periods of six weeks.
干预措施: Ferric carboxymaltose (Drug)
Placebo
The placebo-controlled group will receive four dosages of 250 mL of NaCl 0.9% solution with interval periods of six weeks.
干预措施: Sodium chloride (Drug)
结局指标
主要结局
Exercise tolerance
时间窗: 24 weeks
The between-group difference in change in exercise tolerance quantified by the six-minute walk test (6MWT)
次要结局
- Hemoglobin level(24 weeks)
- Muscle mass(24 weeks)
- Phosphate level(24 weeks)
- Parathyroid hormone(24 weeks)
- FGF23(24 weeks)
- Incidence of hospitalisation(24 weeks)
- Incidence of cardiac events(24 weeks)
- Lymphocyte proliferation rate(24 weeks)
- Cognitive performance (semantic memory)(24 weeks)
- Plasma creatinine(24 weeks)
- Iron status(24 weeks)
- Muscle strength 3(24 weeks)
- Calcium level(24 weeks)
- Cognitive performance (memory span)(24 weeks)
- Quality of Life (subjective fatigue)(24 weeks)
- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination T-lymphocyte response(12 months)
- Gastro-intestinal symptoms(24 weeks)
- Cardiac function(24 weeks)
- Muscle strength 1(24 weeks)
- Vitamin D status(24 weeks)
- Intestinal microbiota(24 weeks)
- Incidence of any infection(24 weeks)
- Incidence of graft failure(24 weeks)
- Lymphocyte production of cytokines(24 weeks)
- Lymphocyte production of immunoglobulins(24 weeks)
- B-lymphocyte differentiation rate(24 weeks)
- Cognitive performance (verbal memory)(24 weeks)
- Cognitive performance (processing speed)(24 weeks)
- Cognitive performance (executive control)(24 weeks)
- Cognitive performance (working memory)(24 weeks)
- Muscle strength 2(24 weeks)
- Cognitive performance (visuomotor and mental speed)(24 weeks)
- Cognitive performance (cognitive flexibility)(24 weeks)
- Quality of Life (health)(24 weeks)
- Quality of Life (long-lasting fatigue)(24 weeks)
- Quality of Life (overall)(24 weeks)
- Hepatic injury(24 weeks)
- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination IgG response(12 months)
- Restless legs(24 weeks)
- Kidney graft rejection and injury(24 weeks)
研究者
Martin H. de Borst
Principal Investigator, Clinical Professor
University Medical Center Groningen