预约演示
更新于：2025-05-24
Sevelamer Hydrochloride
盐酸司维拉姆
更新于：2025-05-24
概要
基本信息
药物类型 聚合物 |
别名 Sevelamer hydrochloride (JAN/USAN)、GT16-026A、PB-94 + [4] |
作用方式 调节剂 |
作用机制 Phosphates 调节剂(磷酸盐 调节剂)、螯合剂 |
非在研适应症 |
原研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (1998-10-30), |
最高研发阶段(中国)无进展 |
特殊审评- |
登录后查看时间轴
结构/序列
分子式C6H13Cl2NO |
InChIKeyKHNXRSIBRKBJDI-UHFFFAOYSA-N |
CAS号152751-57-0 |
关联
30
项与 盐酸司维拉姆 相关的临床试验NCT06660524
Clinical Study on the Influence of Calcium and Phosphorus Regulation Therapy on Valvular Heart Disease.
TCTR20230530004
Protein-bound uremic toxin lowering effects of sevelamer in end-stage kidney disease receiving hemodialysis with hyperphosphatemia: a randomized controlled trial
IRCT20200724048193N1
Comparing the Effect of Sevelamer Hydrochloride and Calcium Carbonate on Serum Level of hs-CRP, Soluable CD-14 and Endotoxin in Hemodialysis Patients
100 项与 盐酸司维拉姆 相关的临床结果
登录后查看更多信息
100 项与 盐酸司维拉姆 相关的转化医学
登录后查看更多信息
100 项与 盐酸司维拉姆 相关的专利（医药）
登录后查看更多信息
602
项与 盐酸司维拉姆 相关的文献（医药）2025-05-01Clinical Journal of the American Society of Nephrology
Efficacy and Safety of Phosphate-Lowering Agents for Adult Patients with CKD Requiring Dialysis
Article
作者: Noma, Hisashi ; Hamano, Takayuki ; Mizukami, Aya ; Kimura, Hiroshi ; Yamada, Shunsuke ; Hasegawa, Takeshi ; Fukagawa, Masafumi ; Nishimoto, Masatoshi ; Nishiwaki, Hiroki ; Taniguchi, Masatomo ; Murashima, Miho ; Saito, Hirotaka
Key Points:
Sevelamer was associated with lower all-cause mortality compared with calcium-based agents.Sucroferric oxyhydroxide and tenapanor were estimated to rank high in lowering all-cause mortality compared with other phosphate-lowering agents.Sucroferric oxyhydroxide and lanthanum were associated with slower progression of coronary artery calcium score compared with calcium-based agents.
Background:
It is necessary to update the evidence of each phosphate-lowering agent on dialysis patients.
Methods:
From the CENTRAL, MEDLINE, Embase, and ClinicalTrial.gov databases, randomized controlled trials using oral phosphate-lowering agents on adult patients requiring maintenance dialysis were extracted. The treatment period was required for 8 or more weeks, and the risk of bias was assessed according to the Cochrane Collaboration method. The outcomes were all-cause mortality, cardiovascular mortality, gastrointestinal events, fracture, coronary artery calcium score (CACS), serum calcium, phosphate, intact parathyroid hormone, and bicarbonate levels. A network meta-analyses using multivariate random-effects models were performed for assessing the comparative effectiveness. The ranking of the phosphate-lowering agents was assessed using a surface under the cumulative ranking curve.
Results:
A total of 70 randomized controlled trials involving 15,551 participants were included. Eleven phosphate-lowering agents including calcium-based agents, sevelamer, bixalomer, lanthanum, sucroferric oxyhydroxide, ferric citrate, tenapanor, magnesium, nicotinamide, aluminum, and sucralfate were assessed. Sevelamer was significantly associated with lower all-cause mortality compared with calcium-based agents (risk ratio [95% confidence interval]: 0.59 [0.37 to 0.94]), and sucroferric oxyhydroxide and tenapanor were estimated to rank high in lowering all-cause mortality on the basis of the surface under the cumulative ranking curve. The risk of gastrointestinal events was the highest with nicotinamide, followed by sucroferric oxyhydroxide. Compared with calcium-based agents, CACS was significantly lower among those on lanthanum and sucroferric oxyhydroxide (standardized mean difference [95% confidence interval]: −0.26 [−0.52 to −0.01] and −0.50 [−0.95 to−0.06], respectively). Serum calcium levels were higher, and serum intact parathyroid hormone levels were lower in patients treated with calcium-based agents. Except for sevelamer, serum bicarbonate levels for all other agents were higher compared with placebo.
Conclusions:
Compared with calcium-based agents, sevelamer was associated with lower all-cause mortality, and sucroferric oxyhydroxide and lanthanum were associated with slower progression of CACS. Potential benefits and harms should be considered when selecting phosphate-lowering agents (International prospective register of systematic reviews: CRD42022328388).
2025-04-01Kidney International Reports
A Pan-Inhibitor of Phosphate Transporters AP306 in Hemodialysis Patients
Article
作者: Wang, Yu ; Luo, Qun ; Zuo, Li ; Shi, Ming ; Zhang, Ping ; Li, Guisen ; Jiang, Hongli ; Chen, Menghua ; Ma, Kunling ; Liu, Yingxue Cathy ; Zhao, Qing ; Gu, Leyi ; Zhang, Weifeng ; Wang, Li ; Wang, Pei
Introduction:
Hyperphosphatemia in patients undergoing dialysis is not well-controlled. AP306 is a pan-inhibitor of phosphate transporters, designed to block the active uptake of phosphate through the gastrointestinal tract.
Methods:
In this phase 2 randomized, active-controlled, open-label study, hemodialysis patients with serum phosphate between 5.5 and 9.0 mg/dl were randomized to receive either AP306 or sevelamer carbonate for 12 weeks. The primary outcome was the change in serum phosphate levels from baseline until the therapy ceased. AP306 was initiated at 75 mg and adjusted stepwise to 125 mg and 150 mg orally thrice daily every 4 weeks, to maintain serum phosphate between 3.5 and 5.5 mg/dl. Sevelamer levels were adjusted using the same criteria and frequency.
Results:
A total of 27 patients were randomized to receive AP306 and 28 to receive sevelamer. At the end-of-treatment, both AP306 and sevelamer resulted in a significant decrease from baseline in serum phosphate by 2.51 mg/dl (95% confidence interval [CI]:-3.07 to -1.92; P < 0.001) and 1.08 mg/dl (95% CI: -1.58 to -0.59), respectively. The proportions of patients achieving the recommended range as per the Kidney Disease: Improving Global Outcomes guidelines (2.5-4.5 mg/dl) were about 20% higher in AP306 than in sevelamer, starting from treatment week 5. The most reported adverse events (AEs) associated with AP306 were gastrointestinal disorders (51.9%), most of which were mild to moderate diarrhea (44.4%).
Conclusion:
AP306 monotherapy significantly reduced serum phosphate levels and substantially improved the serum phosphate control rate in hemodialysis patients with hyperphosphatemia. AP306 was safe and well-tolerated.
2025-02-01JOURNAL OF RENAL NUTRITION
Gastrointestinal mucosal cell injury caused by sevelamer crystals- Case series and literature review
Article
作者: Ali, Umair ; Singh, Manisha ; Karakala, Nithin ; Elkalashy, Ahmed ; Elbahnasawy, Enas ; Rainwater, Randall R
In end-stage-kidney-disease (ESKD) hyperphosphatemia occurs secondary to decreased renal elimination with continued intestinal absorption of dietary phosphate. Even in chronic kidney disease, glomerular filtration rate lower than 30 ml/min markedly decreases the filtration of inorganic phosphate and increases its serum level. Sevelamer, a non-calcium phosphate binder, is commonly used to control hyperphosphatemia. Available in two forms- sevelamer hydrochloride and sevelamer carbonate, it absorbs phosphate in the gastrointestinal tract and is known to have minimal adverse effects. These are limited to nausea, vomiting, flatulence, and metabolic acidosis, with infrequent significant adverse outcomes. We present a series of two patients with ESKD on sevelamer, with lower gastrointestinal bleeding and endoscopic findings of colonic mucosal injuries with histopathologic findings of sevelamer crystals deposition. Though reported in gastrology literature, nephrology reports show a paucity of discussion around this increasingly common adverse effect and the need for vigilance in ESKD.
100 项与 盐酸司维拉姆 相关的药物交易
登录后查看更多信息
研发状态
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 慢性肾病-矿物质和骨骼疾病 | 欧盟 | 2015-02-25 | |
| 慢性肾病-矿物质和骨骼疾病 | 冰岛 | 2015-02-25 | |
| 慢性肾病-矿物质和骨骼疾病 | 列支敦士登 | 2015-02-25 | |
| 慢性肾病-矿物质和骨骼疾病 | 挪威 | 2015-02-25 | |
| 慢性肾病 | 澳大利亚 | 2005-06-30 | |
| 高磷血症 | 欧盟 | 2000-01-28 | |
| 高磷血症 | 冰岛 | 2000-01-28 | |
| 高磷血症 | 列支敦士登 | 2000-01-28 | |
| 高磷血症 | 挪威 | 2000-01-28 | |
| 终末期肾脏病 | 美国 | 1998-10-30 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 20 | Low Fat diet+Maltodextrin (Placebo) | 築鑰膚餘顧鏇廠壓蓋鬱(淵壓廠簾築顧遞繭憲醖) = 壓糧壓衊鏇廠衊選淵廠 齋淵鹽淵遞廠壓構淵憲 (憲製窪獵艱餘遞齋範鏇, 0) 更多 | - | 2021-10-15 | ||
Low Fat diet+Sevelamer (Sevelamer) | 築鑰膚餘顧鏇廠壓蓋鬱(淵壓廠簾築顧遞繭憲醖) = 廠選齋範網蓋衊窪繭積 齋淵鹽淵遞廠壓構淵憲 (憲製窪獵艱餘遞齋範鏇, 2.4) 更多 | ||||||
临床2期 | 69 | NGT (Lean With NGT-Placebo) | 鏇膚鬱鹹顧製願窪襯憲(糧窪淵遞齋糧襯襯顧構) = 鹹顧鏇選遞網網衊鹹築 繭繭遞艱廠衊襯範憲遞 (餘窪築觸鹽構顧築餘夢, 3.78) 更多 | - | 2020-09-11 | ||
(Lean With NGT-Sevelamer) | 鏇膚鬱鹹顧製願窪襯憲(糧窪淵遞齋糧襯襯顧構) = 淵顧製遞獵製願糧遞鏇 繭繭遞艱廠衊襯範憲遞 (餘窪築觸鹽構顧築餘夢, 2.25) 更多 | ||||||
临床3期 | 213 | PA21 (Sucroferric Oxyhydroxide) | 鏇構觸繭鏇衊夢範構醖(構鬱鬱淵衊廠遞製廠積) = 鏇築製夢鹽範淵鑰繭築 觸憲蓋繭鏇遞廠簾構憲 (襯糧繭衊壓選艱築鹽範 ) 更多 | 积极 | 2015-11-03 | ||
鏇構觸繭鏇衊夢範構醖(構鬱鬱淵衊廠遞製廠積) = 窪觸憲夢壓鏇製鏇襯蓋 觸憲蓋繭鏇遞廠簾構憲 (襯糧繭衊壓選艱築鹽範 ) 更多 | |||||||
N/A | 111 | Sevelamer based PB | 願糧憲襯積窪淵築壓願(鏇選鹹觸窪膚艱壓憲構) = 簾觸鏇遞顧糧構簾簾築 憲廠繭齋遞簾蓋鬱鬱構 (鹽廠壓窪繭遞襯窪壓願 ) 更多 | 积极 | 2015-05-21 | ||
Calcium based PB | 願糧憲襯積窪淵築壓願(鏇選鹹觸窪膚艱壓憲構) = 淵構衊憲鏇範願衊鏇蓋 憲廠繭齋遞簾蓋鬱鬱構 (鹽廠壓窪繭遞襯窪壓願 ) 更多 | ||||||
N/A | 追加 | - | 餘築繭蓋網簾顧鏇積襯(夢衊蓋鹽淵網製蓋鹹膚) = 鹽築糧繭選蓋餘醖鬱觸 網壓遞壓鹹齋夢選網衊 (餘窪憲鏇壓憲憲齋壓範 ) | 积极 | 2014-05-01 | ||
No Sevelamer | 餘築繭蓋網簾顧鏇積襯(夢衊蓋鹽淵網製蓋鹹膚) = 顧鏇鑰淵襯糧願願醖壓 網壓遞壓鹹齋夢選網衊 (餘窪憲鏇壓憲憲齋壓範 ) | ||||||
N/A | 高磷血症 维持 | 138 | 製鬱夢壓網廠繭選選廠(繭膚鏇構廠遞壓鹹簾淵) = Gastrointestinal symptoms, of which most were mild or moderate, happened to 68.12% patients 艱窪製醖鹹遞選獵衊鹹 (夢淵餘獵壓顧遞鏇衊製 ) | 积极 | 2011-11-08 | ||
临床3期 | 203 | 鹽範顧願鑰鏇獵醖繭構(憲築餘齋觸膚積淵鹽鹹) = more frequent with SBR759 膚繭鬱憲衊醖糧鏇獵淵 (糧鑰顧鹹選築襯壓鏇廠 ) 更多 | 积极 | 2010-11-16 | |||
Sevelamer-HCl | |||||||
N/A | 484 | Sevelamer Hydrochloride (SE) | 襯網廠鏇廠願選範築鬱(鏇積醖遞窪獵網願窪願) = 壓餘構鹽範齋衊窪築選 蓋壓鑰積艱齋艱蓋膚願 (獵範網夢餘願鑰淵壓獵 ) 更多 | 积极 | 2010-11-16 | ||
(Non-SE) | 襯網廠鏇廠願選範築鬱(鏇積醖遞窪獵網願窪願) = 蓋衊製糧膚鹽鹽醖顧鹽 蓋壓鑰積艱齋艱蓋膚願 (獵範網夢餘願鑰淵壓獵 ) 更多 | ||||||
临床2期 | 203 | 鏇網遞築襯網膚餘憲齋(顧襯積醖獵顧齋齋餘壓) = Similar incidences of SAE/AE were seen with SBR759 and S-HCl (5.2/90.3% vs 4.4/94.1%); no SAE was drug-related. Overall discontinuation rates were lower with SBR759 (11.9% vs 20.6%) as well as discontinuation due to AE (3.7% vs 13.2%). Most frequent AE category with SBR759 and S-HCl was gastrointestinal (GI) disorders (57.5% vs 64.7%). GI AE intensity was mostly mild with SBR759 (mild 45.5%, moderate 11.2%; severe 0.7%) whereas with S-HCl more moderate and severe AEs were reported (mild 30.9%; moderate 27.9%; severe 5.9%). Diarrhea AEs were more frequent with SBR759 (19.4% vs 10.3%); constipation and abdominal distension affected more patients on S-HCl (5.2% and 25.0% vs 3.0% and 25.0%, respectively). Based on Deficiency of Acquired Immune Deficiency Syndrome (DAIDS) grading, majority of diarrhea AE were of grade 1 (lowest severity) with SBR759 and S-HCl (18.7% vs 10.3%) 壓獵繭淵壓選繭夢衊築 (艱鑰窪範鹹鏇醖構願窪 ) | 积极 | 2010-11-16 | |||
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用