Promod P J, Deshpande R, Mohanty N K, Kulkarni S, Shah H A, Ganju A, Kukreja A, Joshi S
Endocare Clinic and Diagnostic Centre, Vellore, Tamil Nadu.
Parel Hospital, Mumbai, Maharashtra.
J Assoc Physicians India. 2017 Mar;65(3):52-57.
C.E.R.A. reported effective correction of anaemia and was well tolerated in International studies on CKD patients not on dialysis.
The study aimed to describe the management of renal anaemia in CKD patients not on dialysis with C.E.R.A. in routine clinical practice in India.
This was a prospective, single-arm, open-label, multi-centre, non-interventional, Phase IV study which followed 108 CKD Stage III-IV patients, not on dialysis with Hb < 10 g/dL for correction of anaemia with C.E.R.A.
Of the 108 patients with Hb < 10 g/dL at baseline, 83 (90.2%) patients achieved target Hb of 10-12 g/dL and the time taken to achieve correction of anaemia was 9.6 weeks ± 6.13 weeks in the Intent-to-treat population. Haemoglobin concentration increased from 8.59 ± 0.808 g/dL pre-therapy to 10.91 ± 0.634 g/dL post-therapy. The change in mean ± SD Hb value was 2.32 ± 0.174 g/dL. Maintenance of Hb levels within the target range of Hb 10 - 12 g/dL was observed in 78.2% of ITT and 80.8% of the PP population for mean duration of 16.69 weeks. Four patients (3.7%) experienced 5 AEs and 2 patients (1.9%) experienced 3 SAEs in the safety population. As per the treating physician none of the AEs or SAEs was considered related to study drug. There were no deaths reported.
This study demonstrated successful correction of anaemia in Indian patients with C.E.R.A. treatment as well as maintenance of Hb levels within the target range. C.E.R.A. was well tolerated with no new safety concerns specific to the Indian population. The less frequent up to monthly dosing schedule of C.E.R.A. may offer clinicians and patients a simplified regimen of anaemia management as compared to traditional frequently administered (thrice weekly to once weekly) ESAs.
在针对未接受透析的慢性肾脏病（CKD）患者的国际研究中，C.E.R.A.显示出对贫血的有效纠正作用，且耐受性良好。
本研究旨在描述在印度的常规临床实践中，使用C.E.R.A.对未接受透析的CKD患者进行肾性贫血管理的情况。
这是一项前瞻性、单臂、开放标签、多中心、非干预性的IV期研究，对108例未接受透析且血红蛋白（Hb）<10 g/dL的CKD III-IV期患者进行随访，以使用C.E.R.A.纠正贫血。
在基线时Hb<10 g/dL的108例患者中，83例（90.2%）患者达到了10 - 12 g/dL的目标Hb水平，在意向性治疗人群中实现贫血纠正的时间为9.6周±6.13周。血红蛋白浓度从治疗前的8.59±0.808 g/dL增加到治疗后的10.91±0.634 g/dL。平均±标准差Hb值的变化为2.32±0.174 g/dL。在意向性治疗人群的78.2%和符合方案人群的80.8%中观察到Hb水平维持在10 - 12 g/dL的目标范围内，平均持续时间为16.69周。在安全性人群中，4例患者（3.7%）发生了5起不良事件（AE），2例患者（1.9%）发生了3起严重不良事件（SAE）。根据治疗医生的判断，没有AE或SAE被认为与研究药物有关。没有死亡报告。
本研究表明，使用C.E.R.A.治疗可成功纠正印度患者的贫血，并使Hb水平维持在目标范围内。C.E.R.A.耐受性良好，没有针对印度人群的新的安全问题。与传统的频繁给药（每周三次至每周一次）的促红细胞生成素类似物（ESA）相比，C.E.R.A.每月给药一次的给药方案频率较低，可能为临床医生和患者提供一种简化的贫血管理方案。
