Greenwood Sharlene A, Oliveira Benjamin A, Asgari Elham, Ayis Salma, Baker Luke A, Beckley-Hoelscher Nicholas, Goubar Aicha, Banerjee Debasish, Bhandari Sunil, Chilcot Joseph, Burton James O, Kalra Philip A, Lightfoot Courtney J, Macdougall Iain C, McCafferty Kieran, Mercer Thomas H, Okonko Darlington O, Reid Chante, Reid Fiona, Smith Alice C, Swift Pauline A, Mangelis Anastasios, Watson Emma, Wheeler David C, Wilkinson Thomas J, Bramham Kate
King's College Hospital NHS Trust, London, UK.
King's College London, London, UK.
Kidney Int Rep. 2023 May 9;8(8):1496-1505. doi: 10.1016/j.ekir.2023.05.002. eCollection 2023 Aug.
Patients with chronic kidney disease (CKD) are often iron deficient, even when not anemic. This trial evaluated whether iron supplementation enhances exercise capacity of nonanemic patients with CKD who have iron-deficiency.
Prospective, multicenter double-blind randomized controlled trial of nondialysis patients with CKD and iron-deficiency but without anemia (Hemoglobin [Hb] >110 g/l). Patients were assigned 1:1 to intravenous (IV) iron therapy, or placebo. An 8-week exercise program commenced at week 4. The primary outcome was the mean between-group difference in 6-minute walk test (6MWT) at 4 weeks. Secondary outcomes included 6MWT at 12 weeks, transferrin saturation (TSAT), serum ferritin (SF), Hb, renal function, muscle strength, functional capacity, quality of life, and adverse events at baseline, 4 weeks, and at 12 weeks. Mean between-group differences were analyzed using analysis of covariance models.
Among 75 randomized patients, mean (SD) age for iron therapy ( = 37) versus placebo ( = 38) was 54 (16) versus 61 (12) years; estimated glomerular filtration rate (eGFR) (34 [12] vs. 35 [11] ml/min per 1.73 m], TSAT (23 [12] vs. 21 [6])%; SF (57 [64] vs. 62 [33]) μg/l; Hb (122.4 [9.2] vs. 127 [13.2] g/l); 6MWT (384 [95] vs. 469 [142] meters) at baseline, respectively. No significant mean between-group difference was observed in 6MWT distance at 4 weeks. There were significant increases in SF and TSAT at 4 and 12 weeks ( < 0.02), and Hb at 12 weeks ( = 0.009). There were no between-group differences in other secondary outcomes and no adverse events attributable to iron therapy.
This trial did not demonstrate beneficial effects of IV iron therapy on exercise capacity at 4 weeks. A larger study is needed to confirm if IV iron is beneficial in nondialysis patients with CKD who are iron-deficient.
慢性肾脏病（CKD）患者即使未贫血也常缺铁。本试验评估了补铁是否能增强缺铁的非贫血CKD患者的运动能力。
对非透析的CKD且缺铁但未贫血（血红蛋白[Hb]>110 g/l）患者进行前瞻性、多中心双盲随机对照试验。患者按1:1分配接受静脉（IV）铁剂治疗或安慰剂治疗。在第4周开始为期8周的运动计划。主要结局是4周时6分钟步行试验（6MWT）的组间平均差异。次要结局包括12周时的6MWT、转铁蛋白饱和度（TSAT）、血清铁蛋白（SF）、Hb、肾功能、肌肉力量、功能能力、生活质量以及基线、4周和12周时的不良事件。使用协方差分析模型分析组间平均差异。
在75例随机分组的患者中，铁剂治疗组（n = 37）与安慰剂组（n = 38）的平均（标准差）年龄分别为54（16）岁和61（12）岁；估计肾小球滤过率（eGFR）（34[12]对35[11]ml/min/1.73 m²），TSAT（23[12]%对21[6]%）；SF（57[64]对62[33]）μg/l；Hb（122.4[9.2]对127[13.2]）g/l；基线时6MWT分别为（384[95]对469[142]）米。4周时6MWT距离组间未观察到显著的平均差异。4周和12周时SF和TSAT显著升高（P<0.02），12周时Hb显著升高（P = 0.009）。其他次要结局组间无差异，且无铁剂治疗所致不良事件。
本试验未证明静脉铁剂治疗在4周时对运动能力有有益作用。需要进行更大规模的研究来证实静脉铁剂对缺铁的非透析CKD患者是否有益。
