Praxis für Nieren- und Hochdruckkrankheiten, Aachen, Germany.
Clin Drug Investig. 2012 Feb 1;32(2):99-110. doi: 10.2165/11594040-000000000-00000.
The continuous erythropoietin receptor activator (C.E.R.A.) has a long half-life, a relatively low binding affinity for the erythropoiesis receptor and low systemic clearance. These characteristics permit once-monthly dosing, which could reduce staffing requirements and be advantageous for patients. However, outcomes observed during controlled trials of C.E.R.A. have not been assessed under everyday clinical conditions in which physicians make all therapeutic decisions based on their own experience, rather than according to a pre-defined protocol.
This study aimed to assess whether the efficacy and safety of C.E.R.A. reported during controlled trials are reproducible under routine clinical conditions.
This was a non-interventional, single-cohort, multicentre study carried out in 92 specialist nephrology clinics and private practices in Germany. The study included patients with non-dialysis chronic kidney disease and anaemia, with or without current erythropoiesis stimulating agent (ESA) therapy. C.E.R.A. initiation and dosing was at the discretion of the physician. The primary efficacy variable was the proportion of patients for whom all measured haemoglobin (Hb) values during months 7-9 were within the range 11-12 g/dL ('responders').
335 patients received ≥1 dose of C.E.R.A.; 150 had previously received ESA therapy. The mean number of doses was 7.6 per patient over a mean follow-up of 7.9 months. Mean ± SD Hb was 10.7 ± 1.1 g/dL at baseline and 11.3 ± 1.1 g/dL at the final visit (efficacy population, n = 205). The primary endpoint, all measured Hb values during months 7-9 within the range 11-12 g/dL, was achieved by 19.0% (39/205) of patients, increasing to 41.5% for Hb 11-13 g/dL, 42.0% for 10-12 g/dL and 76.6% for Hb ≥10 g/dL. Hb fluctuation during months 7-9 was ≤1 g/dL in 185/205 patients (90.2%). C.E.R.A. was well tolerated without novel safety concerns.
Hb levels remained stable during routine use of C.E.R.A. in an unselected population of non-dialysis chronic kidney disease patients with anaemia. C.E.R.A. was administered approximately monthly compared with 3-7 doses per month on previous ESA therapy.
持续的红细胞生成素受体激活剂（C.E.R.A.）半衰期长，对红细胞生成素受体的亲和力相对较低，全身清除率低。这些特性允许每月给药一次，这可以减少人员配备需求，对患者有利。然而，在 C.E.R.A.的对照试验中观察到的结果尚未在日常临床情况下进行评估，在日常临床情况下，医生根据自己的经验而不是根据预先确定的方案做出所有治疗决策。
本研究旨在评估在常规临床情况下，C.E.R.A.在对照试验中报告的疗效和安全性是否具有重现性。
这是一项非干预性、单队列、多中心研究，在德国 92 家专科肾病诊所和私人诊所进行。该研究包括非透析慢性肾脏病伴或不伴当前红细胞生成刺激剂（ESA）治疗的贫血患者。C.E.R.A.的起始和剂量由医生决定。主要疗效变量是在第 7-9 个月内所有测量的血红蛋白（Hb）值均在 11-12g/dL 范围内的患者比例（“应答者”）。
335 名患者接受了至少一剂 C.E.R.A.；150 名患者之前接受过 ESA 治疗。平均每位患者在平均 7.9 个月的随访期间接受了 7.6 剂。基线时平均 Hb 为 10.7±1.1g/dL，最后一次就诊时为 11.3±1.1g/dL（疗效人群，n=205）。主要终点是在第 7-9 个月内所有测量的 Hb 值均在 11-12g/dL 范围内，205 名患者中有 19.0%（39/205）达到，Hb 为 11-13g/dL 的比例增加到 41.5%，Hb 为 10-12g/dL 的比例增加到 42.0%，Hb≥10g/dL 的比例增加到 76.6%。在 205 名患者中，185 名（90.2%）患者在第 7-9 个月期间 Hb 波动≤1g/dL。C.E.R.A.耐受性良好，无新的安全性问题。
在非透析慢性肾脏病贫血患者的未选择人群中，常规使用 C.E.R.A.时，Hb 水平保持稳定。与之前 ESA 治疗时每月 3-7 剂相比，C.E.R.A.每月给药约一次。
