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Correlations of the Complement Proteins MASP-2 and MASP-3 With Clinical Severity and Short-Term Outcomes in Primary Membranous Nephropathy Patients. 补体蛋白MASP-2和MASP-3与原发性膜性肾病患者临床严重程度和短期预后的相关性
IF 2.4 4区 医学
Nephrology Pub Date : 2025-05-01 DOI: 10.1111/nep.70041
Tong Liu, Miao Hu, Yujie Bai, Jiayan Zhang, Yi Deng, Lei Shen, Ling Zhou
{"title":"Correlations of the Complement Proteins MASP-2 and MASP-3 With Clinical Severity and Short-Term Outcomes in Primary Membranous Nephropathy Patients.","authors":"Tong Liu, Miao Hu, Yujie Bai, Jiayan Zhang, Yi Deng, Lei Shen, Ling Zhou","doi":"10.1111/nep.70041","DOIUrl":"https://doi.org/10.1111/nep.70041","url":null,"abstract":"<p><strong>Aim: </strong>This study aimed to explore the serum levels of mannose binding lectin-associated serine protease 2(MASP-2) and 3(MASP-3) in primary membranous nephropathy (PMN) patients and its correlation with clinical activity and short-term prognosis.</p><p><strong>Methods: </strong>Serum levels of MASP-2, MASP-3 and C5a were measured in 72 PMN patients, 71 IgAN patients and 30 healthy controls via enzyme-linked immunosorbent assay (ELISA). Correlations between complement activation biomarkers and clinical parameters were analysed using Spearman correlation. Logistic regression analysis was used to identify risk factors for short-term clinical non-remission in PMN patients, and the predictive performance of the factors was evaluated using ROC curves and the area under the ROC curve (AUC).</p><p><strong>Results: </strong>Serum MASP-2 levels in the PMN group were lower than in both the healthy control and IgAN groups, while levels in the IgAN group were higher than in the healthy control group. Serum levels of MASP-3 and C5a in the PMN group were not significantly different from those in the IgAN group. Both patient groups had significantly elevated serum levels of MASP-3 and C5a compared to the healthy control group. In PMN patients, serum MASP-3 and C5a levels correlated with clinical indicators such as eGFR, serum creatinine and 24-h urinary protein. Multivariate logistic regression analysis revealed that serum anti-phospholipase A<sub>2</sub> receptor antibody (anti-PLA<sub>2</sub>R-ab) and MASP-3 were independent risk factors for the non-remission of PMN at 12 months. The combined detection of serum MASP-3 and anti-PLA<sub>2</sub>R-ab had a greater AUC for predicting early non-remission than either factor alone.</p><p><strong>Conclusion: </strong>Serum MASP-3 and C5a can serve as biomarkers reflecting the clinical severity of PMN. The combined detection of serum MASP-3 and anti-PLA<sub>2</sub>R-ab will improve the prediction efficiency of PMN prognosis.</p>","PeriodicalId":19264,"journal":{"name":"Nephrology","volume":"30 5","pages":"e70041"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144009111","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Diagnostic Value and Mechanism of Action of Serum miR-1281 Involved in T2DM and Complications of DKD. 血清miR-1281参与T2DM及DKD并发症的诊断价值及作用机制
IF 2.4 4区 医学
Nephrology Pub Date : 2025-05-01 DOI: 10.1111/nep.70052
Cuicui Hao, Cui Li, Junhong Wang, Shan Yu
{"title":"Diagnostic Value and Mechanism of Action of Serum miR-1281 Involved in T2DM and Complications of DKD.","authors":"Cuicui Hao, Cui Li, Junhong Wang, Shan Yu","doi":"10.1111/nep.70052","DOIUrl":"https://doi.org/10.1111/nep.70052","url":null,"abstract":"<p><strong>Objective: </strong>To research the diagnostic value and mechanism of miR-1281 involved in type 2 diabetes mellitus (T2DM) and diabetic kidney disease (DKD).</p><p><strong>Methods: </strong>One hundred and eighteen patients with T2DM (68 DKD patients) and 35 healthy individuals were included. Fasting venous blood and one-time morning urine were collected for biochemical testing. RT-qPCR detected miR-1281 expression, ROC curve assessed the diagnostic value of miR-1281 for T2DM and DKD, and logistic regression predicted risk factors affecting the progression of DKD. ELISA analysed inflammatory cytokine expression, and Pearson correlation assessed its relevance to miR-1281. CCK8 detected cell proliferation and flow cytometry recorded apoptosis.</p><p><strong>Results: </strong>miR-1281 was upregulated in T2DM patients and increased more significantly in DKD patients. The ROC curves indicated that miR-1281 had diagnostic value in predicting T2DM and DKD, and miR-1281 was closely related to the pathological characteristics of DKD patients. The logistic results showed that increased miR-1281 expression was a risk factor for DKD progression. ELISA showed that inflammatory cytokines (IL-6, IL-18, TNF-α) were significantly increased in patients with T2DM, and Pearson correlation analysis indicated a positive correlation between miR-1281 and inflammatory cytokine expression. The high-glucose environment promoted cell proliferation, decreased apoptosis, and increased inflammatory factor levels, but transfection of the miR-1281 inhibitor resisted the adverse effects of the high-glucose environment on cells.</p><p><strong>Conclusion: </strong>miR-1281 promotes glomerular cell proliferation, inhibits apoptosis, and increases the level of intracellular inflammation, leading to impaired renal function in T2DM patients.</p>","PeriodicalId":19264,"journal":{"name":"Nephrology","volume":"30 5","pages":"e70052"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144033991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Executive Summary of the Asian Pacific Society of Nephrology Clinical Practice Guideline on Diabetic Kidney Disease-2025 Update. 亚太肾脏病学会糖尿病肾病临床实践指南2025更新执行摘要
IF 2.4 4区 医学
Nephrology Pub Date : 2025-05-01 DOI: 10.1111/nep.70031
Adrian Liew, Sunita Bavanandan, Chuan-Ming Hao, Soo Kun Lim, Narayan Prasad, Manisha Sahay, Paweena Susantitaphong, Veena Roberts, Eranga Wijewickrama, Muh Geot Wong, Sydney C W Tang
{"title":"Executive Summary of the Asian Pacific Society of Nephrology Clinical Practice Guideline on Diabetic Kidney Disease-2025 Update.","authors":"Adrian Liew, Sunita Bavanandan, Chuan-Ming Hao, Soo Kun Lim, Narayan Prasad, Manisha Sahay, Paweena Susantitaphong, Veena Roberts, Eranga Wijewickrama, Muh Geot Wong, Sydney C W Tang","doi":"10.1111/nep.70031","DOIUrl":"https://doi.org/10.1111/nep.70031","url":null,"abstract":"","PeriodicalId":19264,"journal":{"name":"Nephrology","volume":"30 5","pages":"e70031"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12053225/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144026100","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Podocyte Infolding Glomerulopathy: Case Series From a Tertiary Hospital in India. 足细胞折叠性肾小球病:来自印度一家三级医院的病例系列。
IF 2.4 4区 医学
Nephrology Pub Date : 2025-05-01 DOI: 10.1111/nep.70045
Devika Chauhan, Swarnim Swarnim, Bhavana Asit Mehta, Aakash Batra, Anurag Rohatgi, Vineeta Vijay Batra
{"title":"Podocyte Infolding Glomerulopathy: Case Series From a Tertiary Hospital in India.","authors":"Devika Chauhan, Swarnim Swarnim, Bhavana Asit Mehta, Aakash Batra, Anurag Rohatgi, Vineeta Vijay Batra","doi":"10.1111/nep.70045","DOIUrl":"https://doi.org/10.1111/nep.70045","url":null,"abstract":"<p><p>Podocyte infolding glomerulopathy is a rare pathological entity characterised by invagination of the podocyte cell membrane into the glomerular basement membrane with presence of microspheres and/or microtubules on electron microscopy. Without an ultrastructure study, it is often confused with and misdiagnosed as membranous nephropathy. The pathogenesis of this disease remains unclear and the majority of cases show association with connective tissue disorders. There is an ongoing debate on whether it represents a distinct disease entity or merely an unusual renal pathological finding of coexisting disease. Till date, only a single case report has been reported from India. We present a series of 4 cases from India along with a review of literature. This case series aims to provide some insights highlighting the clinical, light microscopic, and diagnostic electron microscopic aspects of this uncommon entity.</p>","PeriodicalId":19264,"journal":{"name":"Nephrology","volume":"30 5","pages":"e70045"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144012528","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evolving Gender Dynamics in India's Nephrology Workforce: A Decadal Analysis (2013-2023). 印度肾脏病工作人员的性别动态变化:十年分析(2013-2023)。
IF 2.4 4区 医学
Nephrology Pub Date : 2025-05-01 DOI: 10.1111/nep.70047
Priti Meena, Garima Aggarwal, Urmila Anandh, Manjusha Yadla, Manisha Sahay, Arpita Ray Chaudhury, Vinant Bhargava, P S Priyamvada, Natarajan Gopalakrishnan, Swarnalatha Guditi, Manjuri Sharma, Vivek Kute, M Edwin Fernando, Vinoi G David
{"title":"Evolving Gender Dynamics in India's Nephrology Workforce: A Decadal Analysis (2013-2023).","authors":"Priti Meena, Garima Aggarwal, Urmila Anandh, Manjusha Yadla, Manisha Sahay, Arpita Ray Chaudhury, Vinant Bhargava, P S Priyamvada, Natarajan Gopalakrishnan, Swarnalatha Guditi, Manjuri Sharma, Vivek Kute, M Edwin Fernando, Vinoi G David","doi":"10.1111/nep.70047","DOIUrl":"https://doi.org/10.1111/nep.70047","url":null,"abstract":"<p><p>The field of medicine has long been marked by gender disparities, with men predominantly occupying higher academic ranks while women were underrepresented. In recent years, there have been marked changes in the gender ratio among medical professionals in Nephrology. This study analysed gender dynamics within the Indian Nephrology fraternity. The primary objectives were to evaluate the gender distribution among nephrology residents/fellows in subspecialty courses over the past decade (2013-2023), faculty members, and heads of departments (HODs). Data was collected from 27 academic centres. Data from 27 institutions showed a consistent increase in nephrology residents, from 76 in 2013 to 112 in 2023. The proportion of female residents increased significantly from 22.4% in 2013 to 38.4% in 2023. A statistically significant increase in female residents (p < 0.05), alongside a corresponding decrease in male residents, was noted. Among faculty members, 22.4% were females, and 20.4% of HODs were female. Female representation on the governing council of the Indian Society of nephrology (ISN) was limited. Since its inception, the role of ISN secretary has been held by eight individuals, all of whom have been male. Since 1971, the ISN has had a total of 42 presidents, with only 4 being female. The editorialship of IJN has never been stewarded by a female member to date. The findings demonstrate a positive trend towards gender parity in India's nephrology workforce over the past decade, reflecting broader societal acceptance and enhanced support for women in nephrology.</p>","PeriodicalId":19264,"journal":{"name":"Nephrology","volume":"30 5","pages":"e70047"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143972652","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
New Diagnosis of Lupus Nephritis in the Third Trimester-A Case Report. 晚期狼疮性肾炎新诊断1例报告。
IF 2.4 4区 医学
Nephrology Pub Date : 2025-05-01 DOI: 10.1111/nep.70037
Umesha Pathmanathan, Sivasaaini Sivakumaran, Jade Eccles-Smith, Ann-Maree Craven, Jill Parkes Smith, Prianka Puri, Kirsten Hepburn
{"title":"New Diagnosis of Lupus Nephritis in the Third Trimester-A Case Report.","authors":"Umesha Pathmanathan, Sivasaaini Sivakumaran, Jade Eccles-Smith, Ann-Maree Craven, Jill Parkes Smith, Prianka Puri, Kirsten Hepburn","doi":"10.1111/nep.70037","DOIUrl":"https://doi.org/10.1111/nep.70037","url":null,"abstract":"<p><p>New-onset lupus nephritis (LN) poses a diagnostic and management challenge during pregnancy. This is more pertinent in the indigenous population, where the prevalence is higher, and the clinical phenotype tends to be more severe. We report the case of a 30-year-old G3P2 indigenous female, living in remote Queensland, with a late presentation of nephrotic syndrome at 30 weeks gestation. A clinical diagnosis of Class V LN was made without a kidney biopsy due to maternal and foetal risk, and she was empirically treated with steroids and disease-modifying agents to good effect. She remained normotensive with appropriate foetal growth and delivered a healthy male infant at 37 weeks. A renal biopsy taken 9 weeks after commencement of therapy demonstrated Class II LN, likely representing a resolving flare in the presence of improved clinical symptoms.</p>","PeriodicalId":19264,"journal":{"name":"Nephrology","volume":"30 5","pages":"e70037"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12037236/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144004776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Diagnostic Potential of Dp-ucMGP as a Biomarker for Early Detection of Diabetic Kidney Disease in Patients With Type 2 Diabetes Mellitus: A Cross-Sectional Study. Dp-ucMGP作为2型糖尿病患者糖尿病肾病早期检测的生物标志物的诊断潜力:一项横断面研究
IF 2.4 4区 医学
Nephrology Pub Date : 2025-05-01 DOI: 10.1111/nep.70050
Farazul Hoda, Mawrah Arshad, Mohammad Ahmad Khan, Mohammad Anwar Habib, Abul Kalam Najmi
{"title":"Diagnostic Potential of Dp-ucMGP as a Biomarker for Early Detection of Diabetic Kidney Disease in Patients With Type 2 Diabetes Mellitus: A Cross-Sectional Study.","authors":"Farazul Hoda, Mawrah Arshad, Mohammad Ahmad Khan, Mohammad Anwar Habib, Abul Kalam Najmi","doi":"10.1111/nep.70050","DOIUrl":"https://doi.org/10.1111/nep.70050","url":null,"abstract":"<p><strong>Aim: </strong>The limited evidence reports the relationship between plasma dephosphorylated uncarboxylated matrix Gla protein (dp-ucMGP) and Diabetic kidney disease (DKD) in patients with Type 2 Diabetes Mellitus (T2DM). Therefore, the present study aimed to evaluate the diagnostic potential of dp-ucMGP in DKD among T2DM patients.</p><p><strong>Method: </strong>This cross-sectional study was conducted from December 2023 to January 2025, including 75 T2DM patients. Participants were classified into three groups based on urinary albumin-to-creatinine ratio (UACR): Normoalbuminuria, microalbuminuria, and macroalbuminuria with n = 25 in each group. Pearson correlation analysis was performed to assess the relationship between dp-ucMGP and other biochemical parameters. Receiver Operating Characteristic (ROC) curve analysis was used to evaluate the diagnostic potential of dp-ucMGP for early detection of DKD. A p value < 0.05 was considered statistically significant.</p><p><strong>Results: </strong>The plasma dp-ucMGP levels were significantly higher in T2DM patients in the macroalbuminuria group, with a mean of 1069.86 ± 417.56 pmol/L, followed by the microalbuminuria (842.72 ± 342.02 pmol/L) and normoalbuminuria (586.38 ± 336.15 pmol/L) groups. Similarly, higher dp-ucMGP levels were observed in patients with DKD severity stage IV (1401.53 ± 401.49 pmol/L). A negative correlation with eGFR (r = -0.807, p < 0.0001) and a positive correlation with age, serum creatinine, UACR, blood urea, uric acid and triglycerides were observed. The area under the curve (AUC) was 0.913 (95% CI: 0.820-0.960; p < 0.0001) for dp-ucMGP.</p><p><strong>Conclusion: </strong>In conclusion, our findings revealed that plasma dp-ucMGP could be a potential biomarker to predict the early detection of DKD in patients with T2DM.</p>","PeriodicalId":19264,"journal":{"name":"Nephrology","volume":"30 5","pages":"e70050"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144029912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Significance of Menopausal Hormone Therapy on Cognitive Function in Women With CKD. 绝经期激素治疗对慢性肾病妇女认知功能的影响。
IF 2.4 4区 医学
Nephrology Pub Date : 2025-05-01 DOI: 10.1111/nep.70053
Lin Wang, Hong Xia
{"title":"The Significance of Menopausal Hormone Therapy on Cognitive Function in Women With CKD.","authors":"Lin Wang, Hong Xia","doi":"10.1111/nep.70053","DOIUrl":"https://doi.org/10.1111/nep.70053","url":null,"abstract":"","PeriodicalId":19264,"journal":{"name":"Nephrology","volume":"30 5","pages":"e70053"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144004778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Case Report: Something Is Brewing. 病例报告:有些事情正在酝酿。
IF 2.4 4区 医学
Nephrology Pub Date : 2025-05-01 DOI: 10.1111/nep.70051
Kate Brotherton, Bobby Chacko
{"title":"Case Report: Something Is Brewing.","authors":"Kate Brotherton, Bobby Chacko","doi":"10.1111/nep.70051","DOIUrl":"https://doi.org/10.1111/nep.70051","url":null,"abstract":"<p><p>Kava plant root (piper methysticum) is an ingredient used in ceremonial drinks throughout Pacific and South Sea Island communities. Kava is made up of kavalactones; psychoactive compounds that act as central nervous system depressants. The rare occurrence of kavalactone toxicity manifests most commonly with hepatotoxicity, and cases of myoglobinuria have been reported. Our case describes an association of significant kava tea ingestion with acute tubulo-interstitial nephritis. An 18-year-old male, without any medical comorbidities, presented with oliguric acute kidney injury after ingesting 15 cups of kava tea. His creatinine at admission was 223umolL and peaked at 96 h post ingestion at 970umol/L despite intravenous fluid administration. His urine ACR was 196 mg/mmol, with microscopic haematuria; a creatinine kinase was 780 U/L, C3 was mildly reduced (0.77 g/L) with normal C4, and the remainder of a glomerulonephritis screen was negative. He did not have any evidence of hepatotoxicity but was bradycardic with a prolonged QT interval. A urine drug screen was negative for other substances. A kidney biopsy demonstrated severe acute tubulointerstitial nephritis without acute tubular necrosis or evidence of myoglobulin-related injury. He was commenced on oral corticosteroids and had complete recovery of his kidney function after 2 weeks, without requiring kidney replacement therapy. Toxicology analysis of the kava powder identified four different kavalactones without additional substances.</p>","PeriodicalId":19264,"journal":{"name":"Nephrology","volume":"30 5","pages":"e70051"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12059527/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144036876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Non-Inferiority of Subcutaneous Efepoetin Alfa Compared to Methoxy Polyethylene Glycol-Epoetin Beta in Stage 3 or 4 CKD Patients: Insights From a Phase 3 Trial. 在3期或4期CKD患者中,与甲氧基聚乙二醇- epoetin β相比,皮下efpoetin α的非劣效性:来自3期试验的见解
IF 2.4 4区 医学
Nephrology Pub Date : 2025-05-01 DOI: 10.1111/nep.70046
Simon D Roger, Chew Ming Wong, Phisitt Vejakama, Kuspudji Dwitanto Rahardjo, Bang-Gee Hsu, Chang Meng Lee, I-Wen Wu, Chin-Chan Lee, Tunggul Diapari Situmorang, Pajaree Krisanapan, Sadanah Aqashiah Mazlan, Yu-Sen Peng, Johanes Sarwono, Norman De Asis, Domingo Solimen, Jonny, Pornpen Sangthawan, Jin-Bor Chen, Chia-Liang Wang, Sungjin Chung, Agnes Jeans Villaflor, Chul Woo Yang, Wei-Chih Kan, Yu Yang, Jenny Rubio-Bicol, Lee Yee Yan, Sang Ho Lee, Yi-Wen Chiu, Cheng-Hsu Chen, Ki Young Na, Wan Hasnul Halimi Wan Hassah, Young Sun Kang, Bum-Soon Choi, Grace Aquitania, Ki Ryang Na, Mai-Szu Wu, Mohd Kamil Ahmad, Rey Isidto, Vincent Wu, Goh Bak Leong, Junne-Ming Sung, Kajohnsak Noppakun, Kang-Ju Chou, Mohamad Zaimi Abdul Wahab, Seok Joon Shin, Pringgodigdo Nugroho
{"title":"Non-Inferiority of Subcutaneous Efepoetin Alfa Compared to Methoxy Polyethylene Glycol-Epoetin Beta in Stage 3 or 4 CKD Patients: Insights From a Phase 3 Trial.","authors":"Simon D Roger, Chew Ming Wong, Phisitt Vejakama, Kuspudji Dwitanto Rahardjo, Bang-Gee Hsu, Chang Meng Lee, I-Wen Wu, Chin-Chan Lee, Tunggul Diapari Situmorang, Pajaree Krisanapan, Sadanah Aqashiah Mazlan, Yu-Sen Peng, Johanes Sarwono, Norman De Asis, Domingo Solimen, Jonny, Pornpen Sangthawan, Jin-Bor Chen, Chia-Liang Wang, Sungjin Chung, Agnes Jeans Villaflor, Chul Woo Yang, Wei-Chih Kan, Yu Yang, Jenny Rubio-Bicol, Lee Yee Yan, Sang Ho Lee, Yi-Wen Chiu, Cheng-Hsu Chen, Ki Young Na, Wan Hasnul Halimi Wan Hassah, Young Sun Kang, Bum-Soon Choi, Grace Aquitania, Ki Ryang Na, Mai-Szu Wu, Mohd Kamil Ahmad, Rey Isidto, Vincent Wu, Goh Bak Leong, Junne-Ming Sung, Kajohnsak Noppakun, Kang-Ju Chou, Mohamad Zaimi Abdul Wahab, Seok Joon Shin, Pringgodigdo Nugroho","doi":"10.1111/nep.70046","DOIUrl":"https://doi.org/10.1111/nep.70046","url":null,"abstract":"<p><strong>Aim: </strong>Efepoetin alfa, a novel long-acting erythropoietin (EPO)-hybrid Fc fusion protein, represents a promising erythropoiesis-stimulating agent (ESA) for addressing anaemia in chronic kidney disease (CKD) patients. This Phase 3 trial was to assess the efficacy and tolerability of subcutaneous efepoetin alfa in comparison to subcutaneous methoxy polyethylene glycol-epoetin beta in stage 3 or 4 CKD patients.</p><p><strong>Methods: </strong>A randomised, multicentre, open-label Phase 3 trial enrolled 391 CKD stage 3 or stage 4 patients. Subjects underwent a 20-week correction period followed by an 8-week evaluation period. Responders continued treatment for an extra 24-week extension to evaluate long-term safety, maintenance effectiveness, and the longer treatment interval.</p><p><strong>Results: </strong>In the efepoetin alfa Q2W (every 2 weeks) group, the response rate was 75.6%; while in the methoxy polyethylene glycol-epoetin beta Q2W group, the response rate was 69.3%. The difference in the response rate was 6.3% with 95% CI (confidence interval) -3.1% to 15.5%. The lower limit of the 95% CI was above the prespecified non-inferiority margin of -9.0%. Adverse event rates were comparable between the treatment groups.</p><p><strong>Conclusion: </strong>Efepoetin alfa demonstrated non-inferiority to methoxy polyethylene glycol-epoetin beta in correcting anaemia and maintaining haemoglobin (Hb) levels among stage 3 and 4 CKD patients. Moreover, the safety profile of efepoetin alfa was comparable to methoxy polyethylene glycol-epoetin beta.</p>","PeriodicalId":19264,"journal":{"name":"Nephrology","volume":"30 5","pages":"e70046"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12079003/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144079278","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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