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更新于：2026-05-11
Methoxy Polyethylene Glycol-Epoetin Beta
甲氧聚二醇重组人促红素
更新于：2026-05-11
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 欧盟 (2007-07-20), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
Sequence Code 8988
来源: *****
关联
115
项与 甲氧聚二醇重组人促红素 相关的临床试验CTRI/2025/01/078921
A randomized, observer blind, parallel-group, active controlled, single dose study to compare pharmacokinetic, pharmacodynamic, safety and immunogenicity of Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO) of Incepta and Methoxy Polyethylene Glycol-Epoetin Beta 100 micrograms/0.3 ml solution for injection of Roche (Mircera) in healthy adult human subjects. - NIL
TCTR20190718006
A RANDOMIZED, CONTROLLED, OPEN-LABEL, SINGLE-CENTER, PARALLEL GROUP STUDY TO ASSESS THE EFFECT OF MIRCERA ON DELAYING DIALYSIS IN ANEMIC PATIENTS WITH STAGE 5 CHRONIC KIDNEY DISEASE NOT ON DIALYSIS
NCT03552393
An Open-Label, Single-Arm, Multicenter Study to Ascertain the Optimal Starting Dose of MIRCERA® Given Subcutaneously for the Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.
100 项与 甲氧聚二醇重组人促红素 相关的临床结果
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100 项与 甲氧聚二醇重组人促红素 相关的转化医学
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100 项与 甲氧聚二醇重组人促红素 相关的专利（医药）
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474
项与 甲氧聚二醇重组人促红素 相关的文献（医药）2026-05-01Clinical and Experimental Nephrology
Changes in mean corpuscular volume after erythropoiesis-stimulating agent treatment are associated with renal outcomes in non-dialysis-dependent chronic kidney disease
Article
作者: Masaki, Takao ; Sofue, Tadashi ; Nakayama, Masaaki ; Narita, Ichiei ; Son, Raku ; Kagimura, Tatsuo ; Fujimaru, Takuya
Abstract:
Background:
Mean corpuscular volume (MCV) is routinely measured in patients with chronic kidney disease (CKD) and anemia; however, its prognostic significance, particularly in the context of erythropoiesis-stimulating agent (ESA) therapy, remains unclear.
Methods:
We conducted a post hoc analysis of the BRIGHTEN study, a multicenter, prospective trial that enrolled 1219 ESA-naïve patients with non-dialysis-dependent CKD who initiated darbepoetin alfa. Patients were categorized based on changes in MCV from baseline to week 16 as either increased or decreased. The primary outcome was renal function decline, defined as the initiation of dialysis, kidney transplantation, ≥ 50% reduction in estimated glomerular filtration rate (eGFR), or an eGFR ≤ 6 mL/min/1.73 m
2
within 96 weeks.
Results:
MCV decreased in 778 (63.8%) patients during the study period. Changes in MCV were not correlated with baseline MCV values or ESA responsiveness. Over a mean follow-up of 2.46 ± 0.78 years, renal function decline occurred in 304 (39.1%) and 140 (31.7%) patients in the decreased and increased MCV groups, respectively. After adjusting for age, sex, baseline eGFR, albumin, high-sensitivity CRP, proteinuria, ferritin, transferrin saturation and ESA responsiveness, increased MCV remained independently associated with a reduced risk of renal function decline (adjusted hazard ratio 0.67; 95% confidence interval 0.53–0.85;
p
< 0.001).
Conclusion:
In ESA-naïve patients with non-dialysis-dependent CKD, an increase in MCV following ESA treatment was associated with a significantly lower risk of renal function decline. Monitoring MCV dynamics may serve as a simple, adjunctive tool for risk stratification and individualized CKD management.
2026-02-01PHARMACEUTICAL RESEARCH
Forecasting the Biological Effect of PEGylated-rHuEPO Candidates in Chronic Kidney Disease Patients using a Middle-out Translation Approach
Article
作者: Duconge, Jorge ; Amaro, Daniel ; Azeredo, Francine Johansson ; Troconiz, Iñaki F ; Mangas-Sanjuan, Victor ; Vozmediano, Valvanera ; Reynaldo-Fernandez, Gledys ; Solozábal, Joaquin ; Rodriguez-Vera, Leyanis
BACKGROUND:
Anemia is a common and debilitating complication in patients with chronic kidney disease (CKD), often managed with erythropoiesis-stimulating agents. While PEGylation extends drug half-life, it may alter pharmacodynamics, requiring careful dose optimization. This study applies a middle-out translational pharmacokinetic/pharmacodynamic modeling approach, aligned with Model-Informed Drug Development principles, to evaluate two pegylated recombinant human erythropoietin candidates (PEG-EPO 32 kDa and PEG-EPO 40 kDa) and guide dose selection for CKD patients.
METHODS:
A semi-mechanistic pharmacokinetic/pharmacodynamic model developed in rabbits was extrapolated to humans using allometric scaling for pharmacokinetics and physiological adaptation for pharmacodynamics. The model was verified using intravenous data from Mircera®. Simulations were conducted in virtual CKD stage 4 and 5 populations to predict hemoglobin (Hb) trajectories over 90 days of dosing. Clinical thresholds were applied to assess efficacy and safety.
RESULTS:
Simulations with 0.6 µg/kg Q2W reproduced Mircera® profiles but showed higher proportions of patients exceeding Hb safety thresholds (> 11 g/dL in stage 4, > 9 g/dL in stage 5) for both PEG-EPOs. Dose reduction to 0.4 µg/kg Q2W aligned Hb responses with Mircera®, reducing the risk of excessive Hb elevation.
CONCLUSIONS:
Middle-out modeling successfully predicted clinical performance of PEG-EPO candidates and identified 0.4 µg/kg Q2W as optimal starting dose for clinical trials. PEG-EPO 32 kDa and 40 kDa emerges as a promising candidate for further development. This study exemplifies the value of MIDD in optimizing dose selection, enhancing translational relevance, and de-risking early clinical evaluation of long-acting erythropoiesis-stimulating agents in CKD.
2026-02-01Clinical and Experimental Nephrology
Erythropoiesis-stimulating agent hyporesponsiveness and malignancy development in patients with non-dialysis chronic kidney disease: a prospective cohort study
Article
Abstract:
Background:
Erythropoiesis-stimulating agents (ESA) hyporesponsiveness may be linked to malignancy, but studies examining this association are limited. We investigated whether initial ESA hyporesponsiveness and changes in responsiveness may serve as clinical markers reflecting undiagnosed malignancy in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD).
Methods:
We used data from the BRIGHTEN, a prospective study of NDD-CKD patients with anemia. Initial ESA responsiveness was assessed using the erythropoietin resistance index (ERI-1B), calculated as the ratio of darbepoetin-alfa dose (μg) to hemoglobin concentration (g/dL) at 12 weeks after darbepoetin-alfa initiation. ESA responsiveness trends after 12 weeks were analyzed using a joint latent class model (JLCM). The associations of both initial ESA responsiveness and ESA responsiveness trends after 12 weeks with malignancy development were analyzed using a Cox proportional hazards model.
Results:
Of the 1641 patients analyzed, 44 developed new malignancies. Patients with poor ESA response at 12 weeks (ERI-1B > 3.8 μg/g/dL) had a higher incidence of malignancy compared to those with better ESA response (adjusted hazard ratio [HR]: 2.07; 95% confidence interval [CI]: 1.07–4.00). Furthermore, based on the JLCM, patients in the poor response group, characterized by a faster decline in ESA responsiveness after 12 weeks, had a higher risk of malignancy than the good response group (adjusted HR: 2.01; 95% CI: 1.08–3.72).
Conclusion:
Both initial ESA hyporesponsiveness and subsequent declines in responsiveness were significantly associated with the development of malignancy in patients with NDD-CKD. ESA hyporesponsiveness may serve as a clinical marker that reflects an increased risk of undiagnosed malignancy.
100 项与 甲氧聚二醇重组人促红素 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | 甲氧聚二醇重组人促红素 |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 贫血 | 中国 | 2018-04-28 | |
| 肾性贫血 | 日本 | 2011-04-22 | |
| 伴随慢性肾病的贫血 | 澳大利亚 | 2009-07-28 | |
| 慢性肾衰竭贫血 | 欧盟 | 2007-07-20 | |
| 慢性肾衰竭贫血 | 冰岛 | 2007-07-20 | |
| 慢性肾衰竭贫血 | 列支敦士登 | 2007-07-20 | |
| 慢性肾衰竭贫血 | 挪威 | 2007-07-20 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 慢性肾病，V期 | 临床3期 | 美国 | 2007-03-01 | |
| 腹膜透析并发症 | 临床3期 | 日本 | 2007-02-01 | |
| 肾病 | 临床3期 | 日本 | 2007-01-01 | |
| 慢性肾病 | 临床3期 | 美国 | 2004-02-01 | |
| 慢性肾病 | 临床3期 | 巴西 | 2004-02-01 | |
| 慢性肾病 | 临床3期 | 加拿大 | 2004-02-01 | |
| 慢性肾病 | 临床3期 | 捷克 | 2004-02-01 | |
| 慢性肾病 | 临床3期 | 法国 | 2004-02-01 | |
| 慢性肾病 | 临床3期 | 德国 | 2004-02-01 | |
| 慢性肾病 | 临床3期 | 希腊 | 2004-02-01 |
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临床结果
临床结果
适应症
分期
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临床2期 | - | C.E.R.A. SC every 4 weeks | 衊壓願齋蓋顧簾鹽簾範(願淵艱淵製窪憲憲鏇繭) = 鏇淵選獵顧製鏇繭獵獵 構顧網餘醖網鹹製鬱醖 (構憲淵鏇構糧廠鬱鹹積, 1.03) 更多 | 积极 | 2022-05-03 | ||
N/A | 229 | (Peritoneal Dialysis (PD)) | 鑰蓋構襯夢鬱齋壓網獵(衊壓衊顧網顧築艱糧顧) = 121 PD patients (68%) and 36 HD patients (69%) had ≥ 1 hospitalization, of whom 102/121 (84%) and 32/36 (89%), respectively, had non-elective hospitalizations. Median hospitalization surveillance time/patient was 13.5 months in the PD and 18.3 months in the HD cohorts. The most frequent causes for non-elective hospitalization were infections, reported as a cause in 56/177 (32%) patients in the PD cohort and 14/52 (27%) in the HD cohort and technique complications, in 41/177 (23%) patients in the PD cohort and 20/52 (38%) in the HD cohort. 鏇廠鏇獵網觸衊鹹鏇醖 (網選顧獵積鏇醖繭願壓 ) 更多 | 积极 | 2022-05-03 | ||
临床2期 | 40 | 衊鹹鏇選膚淵憲範製憲(窪鹽築壓繭築淵壓夢衊) = 製齋蓋餘廠醖獵齋衊簾 選淵鬱簾餘獵壓餘蓋獵 (獵積觸醖糧鹹淵憲顧窪, 0.51) 更多 | - | 2022-03-07 | |||
临床4期 | 2,818 | 淵繭蓋淵簾築願觸築簾(蓋構選鑰鑰遞獵廠艱膚): HR = 1.06 (95% CI, 0.94 ~ 1.19) 更多 | - | 2019-12-06 | |||
Reference Erythropoiesis-Stimulating Agents | |||||||
临床4期 | 87 | (Pre-dialysis, Sea Level) | 選範簾廠襯艱鑰選憲鬱(獵鹽築製選積鬱淵廠窪) = 築夢壓顧製鏇襯艱網築 積齋齋範餘積鑰鏇簾壓 (醖願鏇淵鏇衊範築選憲, 69.0) 更多 | - | 2018-12-27 | ||
(Dialysis, Sea Level) | 選範簾廠襯艱鑰選憲鬱(獵鹽築製選積鬱淵廠窪) = 簾鏇築遞觸構艱鑰淵網 積齋齋範餘積鑰鏇簾壓 (醖願鏇淵鏇衊範築選憲, 214.2) 更多 | ||||||
临床4期 | 2,825 | (Erythropoiesis Stimulating Agents) | 醖艱積遞築鹹鏇憲壓醖(願顧繭齋衊餘積衊構壓) = 願廠壓窪築繭夢鹹鑰鹹 鹹膚蓋窪選遞膚鏇襯觸 (積鬱鏇網糧襯繭製衊艱, 範選衊衊糧遞構築鹹築 ~ 鹹鏇壓範蓋網觸憲簾衊) 更多 | - | 2018-08-15 | ||
(Methoxy Polyethylene Glycol-Epoetin Beta) | 醖艱積遞築鹹鏇憲壓醖(願顧繭齋衊餘積衊構壓) = 餘鬱窪艱網廠網膚顧築 鹹膚蓋窪選遞膚鏇襯觸 (積鬱鏇網糧襯繭製衊艱, 憲糧選淵餘獵餘膚顧夢 ~ 壓糧繭糧鏇糧積襯蓋蓋) 更多 | ||||||
临床2期 | 64 | 選築窪獵餘鬱簾鬱鬱鬱(壓簾築遞鹽艱衊鏇襯襯) = 選壓築鑰遞艱襯襯鏇鏇 構壓簾積餘顧憲鏇膚淵 (窪憲築膚製鬱醖簾願壓, -0.45 ~ 0.26) 更多 | 积极 | 2018-01-06 | |||
临床2期 | 64 | (MIRCERA Group 1: Intermediate-Conversion-Factor Group) | 遞繭鑰醖鏇構鏇鏇鏇鏇(壓遞繭範餘蓋鬱醖繭選) = 製遞鏇繭夢膚糧繭遞獵 鬱遞鬱願鹹鑰鬱鑰淵觸 (壓窪廠積壓網鏇範廠鹹, 0.496) 更多 | - | 2017-09-08 | ||
(MIRCERA Group 2: High-Conversion-Factor Group) | 遞繭鑰醖鏇構鏇鏇鏇鏇(壓遞繭範餘蓋鬱醖繭選) = 廠選糧簾襯廠壓鹽憲淵 鬱遞鬱願鹹鑰鬱鑰淵觸 (壓窪廠積壓網鏇範廠鹹, 0.493) 更多 | ||||||
临床2期 | 235 | erythropoiesis-stimulating agents | 簾鹽簾夢繭築廠淵糧鹹(顧範糧壓獵醖網顧壓淵) = 窪鬱鏇廠繭顧夢簾糧鏇 襯糧選積憲夢淵網衊製 (壓憲夢網壓窪膚網構範, -2.2 ~ 3.8) 更多 | 不佳 | 2017-02-01 | ||
Placebo | 簾鹽簾夢繭築廠淵糧鹹(顧範糧壓獵醖網顧壓淵) = 鬱窪廠遞醖築齋齋鑰範 襯糧選積憲夢淵網衊製 (壓憲夢網壓窪膚網構範, -2.0 ~ 3.2) 更多 | ||||||
临床3期 | 490 | 膚壓膚網夢構顧構構艱 = 簾艱構廠鹹願醖膚繭餘 獵衊夢壓鹹獵夢憲艱窪 (鹽遞鑰壓繭顧窪餘糧積, 憲齋範蓋構網顧鑰鹹製 ~ 艱艱範艱積壓鑰衊壓遞) 更多 | - | 2017-01-20 | |||
(Darbepoetin Alfa) | 膚壓膚網夢構顧構構艱 = 壓積製構蓋壓願築壓衊 獵衊夢壓鹹獵夢憲艱窪 (鹽遞鑰壓繭顧窪餘糧積, 觸獵顧蓋積積顧遞鹹鹹 ~ 簾鹹鬱餘繭觸餘網憲構) 更多 |
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