Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 160 Pujian Road, Shanghai, China.
Department of Nephrology, Taixing People's Hospital, Taizhou, Jiangsu, China.
Trials. 2021 Oct 10;22(1):691. doi: 10.1186/s13063-021-05663-1.
Anemia is one of the main complications of chronic kidney disease especially kidney failure, which includes treatment with erythropoiesis-stimulating agents and iron supplementation, including intravenous and oral iron. However, intravenous iron may pose limitations, such as potential infusion reactions. Oral iron is mainly composed of divalent iron, which can excessively stimulate the gastrointestinal tract. Iron polysaccharide complex capsules are a novel oral iron trivalent supplement with higher iron content and lower gastrointestinal irritation. However, since high-quality evidence-based medicinal support is lacking, it is necessary to conduct clinical studies to further evaluate the effectiveness and safety of oral iron polysaccharide complex in chronic kidney disease patients.
This randomized controlled trial uses an open-label, parallel group design, where the efficacy and safety of maintenance hemodialysis (MHD) participants is evaluated. The experimental group is assigned erythropoietins and iron polysaccharide complex (two capsules each time, bid), and the control group is assigned erythropoietin and sucrose iron (100mg, 2w) injection. Participants (aged 18-75 years) undergoing maintenance hemodialysis were considered for screening. Inclusion criteria included hemoglobin (Hb) ≥110g/L and < 130g/L, transferrin saturation (TSAT) > 20% and < 50%, and serum ferritin (SF) > 200μg/L and < 500μg/L. Exclusion criteria included acute or chronic bleeding, serum albumin < 35g/L, hypersensitive C-reactive protein (HsCRP) > 10 mg/L, and severe secondary hyperparathyroidism (iPTH ≥ 800 pg/mL). Full inclusion and exclusion criteria are described in the "Methods" section. The primary endpoint is TSAT of the participants at week 12. Secondary endpoints include Hb, SF, hematocrit (Hct), HsCRP, pharmacoeconomic evaluation, drug costs, quality of life, and indicators of oxidative stress. The treatment will last for 24 weeks with a follow-up visit at baseline (within 7 days prior to initial treatment) and weeks 4, 8, 12, 16, 20, and 24 after initial treatment. This clinical research includes 9 hemodialysis centers in mainland China and plans to enroll 186 participants.
It is expected that it will provide strong evidence to reveal the clinical efficacy and safety of oral iron in the treatment of chronic CKD-related anemia in MHD patients through this clinical trial.
Chinese Clinical Trial Registry ChiCTR2000031166 . Registered on March 23, 2020.
贫血是慢性肾脏病（尤其是肾衰竭）的主要并发症之一，其治疗包括使用促红细胞生成素和铁补充剂，包括静脉内和口服铁。然而，静脉内铁可能存在一些限制，例如潜在的输注反应。口服铁主要由二价铁组成，会过度刺激胃肠道。多糖铁复合物胶囊是一种新型的口服三价铁补充剂，具有更高的铁含量和更低的胃肠道刺激性。然而，由于缺乏高质量的循证医学支持，有必要进行临床研究以进一步评估多糖铁复合物在慢性肾脏病患者中的疗效和安全性。
这是一项采用开放标签、平行组设计的随机对照试验，旨在评估维持性血液透析（MHD）参与者的疗效和安全性。实验组给予促红细胞生成素和多糖铁复合物（每次 2 粒，bid），对照组给予促红细胞生成素和蔗糖铁（100mg，2w）注射。筛选年龄在 18-75 岁之间接受 MHD 的参与者。纳入标准包括血红蛋白（Hb）≥110g/L 且＜130g/L、转铁蛋白饱和度（TSAT）＞20%且＜50%、血清铁蛋白（SF）＞200μg/L 且＜500μg/L。排除标准包括急性或慢性出血、血清白蛋白＜35g/L、超敏 C 反应蛋白（HsCRP）＞10mg/L、严重继发性甲状旁腺功能亢进症（iPTH≥800pg/mL）。详细的纳入和排除标准在“方法”部分描述。主要终点是第 12 周时参与者的 TSAT。次要终点包括 Hb、SF、血细胞比容（Hct）、HsCRP、药物经济学评价、药物费用、生活质量和氧化应激指标。治疗持续 24 周，随访时间为基线时（初始治疗前 7 天内）和初始治疗后第 4、8、12、16、20 和 24 周。这项临床研究包括中国大陆的 9 个血液透析中心，计划招募 186 名参与者。
预计通过这项临床试验，将提供强有力的证据揭示口服铁在治疗 MHD 患者慢性 CKD 相关贫血中的临床疗效和安全性。
中国临床试验注册中心 ChiCTR2000031166 。注册于 2020 年 3 月 23 日。
