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更新于：2025-09-19
Sevelamer Carbonate
碳酸司维拉姆
更新于：2025-09-19
概要
基本信息
药物类型 聚合物 |
别名 Renvela(TN)、sevelamer、Sevelamer carbonate (USAN) + [7] |
作用方式 调节剂 |
作用机制 Phosphates 调节剂(磷酸盐 调节剂) |
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2007-10-19), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C7H14ClNO4 |
InChIKeyPADGNZFOVSZIKZ-UHFFFAOYSA-N |
CAS号845273-93-0 |
关联
54
项与 碳酸司维拉姆 相关的临床试验PACTR202408492665945
The Adjuvant Role of Sevelamer in Treatment of Acute Aluminum Phosphide Poisoned Patients
IRCT20210720051946N7
Evaluation the effect of adding Sevelamer to the standard treatment of aluminum phosphide poisoning patients, referred to Tehran's Luqman Hospital, a preliminary studyon mortalit
CTR20230498
一项在健康受试者中评价含钙的磷结合剂醋酸钙片和非含钙的磷结合剂碳酸司维拉姆片对德度司他片的药动学影响的单中心、随机、开放、三周期交叉的I期临床研究
100 项与 碳酸司维拉姆 相关的临床结果
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100 项与 碳酸司维拉姆 相关的转化医学
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100 项与 碳酸司维拉姆 相关的专利（医药）
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297
项与 碳酸司维拉姆 相关的文献（医药）2025-09-01INTERNATIONAL IMMUNOPHARMACOLOGY
Pharmacologic modulation of systemic inorganic phosphate levels restores the impaired phagocytosis of Kupffer cells and improves liver function in murine models of chronic liver failure
Article
作者: Deng, Zhi-Qiang ; Liu, Yue ; Liang, Qing-Rong ; Wang, Le-Ran ; Liao, Zi-Qiang ; Zhang, Chun-Bo ; Tang, Qun ; Chen, Ze-Ning ; Zhou, Bin-Quan ; Xie, Xian-Bing
Chronic liver disease induced by various etiologies (ethanol, viruses, etc.) impairs macrophage phagocytosis. This study demonstrated that such impairment could be alleviated by systemic weak phosphate stress in vitro and in vivo. A cell model of ethanol-induced damage was established by incubating the RAW 264.7 cell line in a low-phosphate medium, and the phagocytic capacity of the injured cells was increased, as evidenced by their increased ability to engulf Escherichia coli and fluorescent microspheres. The transcriptomic analysis combined with laboratory validation by qPCR and Western blotting identified the PI3K-Akt signaling pathway and RAC3 protein as potential contributors. The expression of FcγR was inhibited after injury, but low Pi stress increased its expression to normal levels for foreign body recognition. Moreover, actin polymerization was also increased, which is beneficial for phagosome formation. In both alcohol- and DEN-induced models of chronic liver injury, alcohol exposure led to a decreased phagocytic capacity of liver macrophages (Kupffer cells), which was mitigated by the oral administration of sevelamer (5 % w/w). Immunohistochemical results confirmed the findings from the cellular experiments, revealing consistent expression patterns of FcγR, RAC3, and PI3K-Akt. Furthermore, damage to liver function was ameliorated in both models. In conclusion, these results indicate that the weak phosphate stress induced by sevelamer has therapeutic potential to reverse the impairment of phagocytosis caused by liver injury.
2025-04-01Kidney International Reports
A Pan-Inhibitor of Phosphate Transporters AP306 in Hemodialysis Patients
Article
作者: Wang, Yu ; Luo, Qun ; Zhang, Ping ; Zuo, Li ; Shi, Ming ; 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.
2025-04-01Nephrologie & Therapeutique
The effects of resins added to the milk of children suffering from chronic kidney disease: a clinical relevance to control potassium and phosphate levels?
Article
作者: Ranchin, Bruno ; Naud, Corentin ; Bechara, Rouba ; Chambon, Véronique ; de Mul, Aurélie ; Bacchetta, Justine
Background:
In infants with chronic kidney disease (CKD), the management of nutrition and growth is highly challenging, particularly compared to older children. Management of hyperkalemia and hyperphosphatemia is difficult, and incorporating potassium and phosphate binders directly in formulas could be beneficial, as it avoids direct ingestion of resins by infants.
Materials and methods:
We conducted a study using Gallia® standard first-stage infant formula and Pregestimil®. We added either carbonate sevelamer (Renvela®, 200, 400 or 800 mg) or polystyrene sulfonate (Resikali®, 2000, 4000 or 8000 mg) to 90 ml of formula. Additionally, we evaluated the combined use of the resins with Gallia® by adding in 90 mL 200 mg/2000 mg, 400 mg/4000 mg, and 200 mg/4000 mg of Renvela® and Resikali®, respectively. The Milk was decanted for 10 minutes, and the resulting supernatants were weighted and analyzed for osmolality and pH. Sodium, potassium, chlore, bicarbonate, magnesium, glucose, calcium, phosphate, protein, cholesterol, triglycerides, iron, folate, vitamin B12 levels were measured after centrifugation.
Results:
With polystyrene sulfonate, potassium levels in milk decreased in a dose-dependent manner, by 36%, 52% and 68%, respectively. Polystyrene sulfonate also reduced magnesium levels and increased both calcium concentration (from 9.7 to 21 mmol/L) and osmolality (from 359 to 423 mOsm/kg). No significant effect on phosphate was observed. Sevelamer decreased both calcium and phosphate concentrations in a dose-dependent manner, by 14%, 26% and 29%, and by 24%, 36% and 40%, respectively. Sevelamer also increased pH from 6.9 to 9.1, and decreased folate levels by 32%, 66% and 81% respectively, from 465 to 88 mmol/L. The combined use of sevelamer and polystyrene sulfonate results in decreased levels of potassium (by 45%, 59% and 59%, respectively), phosphate (by 38%, 39% and 36%, respectively), and folate, albeit with a slighter increase in pH. Osmolality remained unchanged and no other relevant differences were observed.
Conclusion:
Pretreating formulas with resins is a reproducible and straightforward method when specific diets for CKD are unavailable. However, it is important to keep in mind that resins may impact the overall composition (osmolality) and the concentration of other nutrients (folates).
100 项与 碳酸司维拉姆 相关的药物交易
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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 |
|---|---|---|---|
| 慢性肾病-矿物质和骨骼疾病 | 欧盟 | 2015-01-15 | |
| 慢性肾病-矿物质和骨骼疾病 | 冰岛 | 2015-01-15 | |
| 慢性肾病-矿物质和骨骼疾病 | 列支敦士登 | 2015-01-15 | |
| 慢性肾病-矿物质和骨骼疾病 | 挪威 | 2015-01-15 | |
| 高磷血症 | 欧盟 | 2009-06-09 | |
| 高磷血症 | 冰岛 | 2009-06-09 | |
| 高磷血症 | 列支敦士登 | 2009-06-09 | |
| 高磷血症 | 挪威 | 2009-06-09 | |
| 慢性肾病 | 美国 | 2007-10-19 |
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 |
|---|---|---|---|---|
| 终末期肾脏病 | 临床3期 | 法国 | 2010-10-01 | |
| 继发性甲状旁腺功能亢进症 | 临床3期 | 美国 | 2010-04-01 | |
| 心血管疾病 | 临床2期 | 英国 | 2009-02-01 | |
| 2型糖尿病 | 临床阶段不明 | 丹麦 | 2014-02-01 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 44 | (TPOXX: Oral Antiviral) | 顧壓衊願齋獵願選願顧(淵鹽網遞鬱窪選鹹糧鬱) = 簾鹹鑰淵齋鹹積網構網 範顧膚鬱網選糧齋襯餘 (觸廠廠窪齋製齋齋遞積, 39.6) 更多 | - | 2024-10-09 | ||
(TPOXX: Oral Antiviral and Sevelamer Carbonate) | 廠鏇遞積鏇鏇鏇鹹憲構(積襯壓構製積製壓觸壓) = 簾襯膚鑰鑰範齋窪鹹齋 觸淵膚餘製廠積襯鬱積 (窪網糧鹽選窪鹹醖獵壓, 遞鬱齋餘顧網淵獵繭鹹 ~ 鑰糧顧積顧蓋衊淵顧夢) 更多 | ||||||
临床3期 | 286 | 遞鹽醖鬱觸鹹衊鏇淵築(廠憲製積憲構製餘鬱簾) = 選夢顧糧鬱艱願選齋醖 廠築簾獵廠醖壓鹹遞鏇 (觸憲齋齋願鹹簾壓壓鏇 ) | 积极 | 2023-07-20 | |||
遞鹽醖鬱觸鹹衊鏇淵築(廠憲製積憲構製餘鬱簾) = 醖襯鹽衊廠繭夢淵遞築 廠築簾獵廠醖壓鹹遞鏇 (觸憲齋齋願鹹簾壓壓鏇 ) | |||||||
临床4期 | 172 | (Tenapanor w/Sevelamer) | 鹽壓艱襯衊醖積醖齋糧 = 蓋範夢觸憲齋夢構網鹽 淵窪鏇憲鑰蓋蓋鹽窪繭 (蓋艱齋積鏇襯壓獵廠繭, 齋積遞觸構餘蓋鏇製網 ~ 壓齋衊積獵鏇鹹顧鏇廠) 更多 | - | 2023-03-29 | ||
(Sevelamer w/Tenapanor) | 鹽壓艱襯衊醖積醖齋糧 = 獵餘獵齋鬱製顧窪糧襯 淵窪鏇憲鑰蓋蓋鹽窪繭 (蓋艱齋積鏇襯壓獵廠繭, 蓋選餘艱醖餘膚製衊鹽 ~ 獵願鬱鏇蓋糧膚鹹糧選) 更多 | ||||||
N/A | 慢性肾病 hyperphosphatemia | - | 鏇壓壓餘廠膚顧衊選觸(鏇獵憲獵衊襯衊選鏇觸): HR = 0.84 (95% CI, 0.79 ~ 0.91) 更多 | 积极 | 2022-11-05 | ||
(Cardiopulmonary Bypass (CPB)) | |||||||
临床3期 | 202 | Placebo (Placebo) | 選鏇壓衊糧鬱選糧簾顧(夢簾願醖壓獵積繭壓餘) = 膚製壓餘遞醖範餘遞蓋 簾鬱廠製衊衊網糧鑰願 (製鹽範膚繭窪鹹鹽鹽積, 淵遞壓艱齋選選糧選鬱 ~ 顧膚繭獵鹹繭構簾窪夢) 更多 | - | 2020-07-28 | ||
(Renvela) | 選鏇壓衊糧鬱選糧簾顧(夢簾願醖壓獵積繭壓餘) = 觸廠壓鬱簾衊壓遞壓鑰 簾鬱廠製衊衊網糧鑰願 (製鹽範膚繭窪鹹鹽鹽積, 繭積獵鏇糧壓製築憲遞 ~ 顧鑰蓋積獵蓋鬱鏇餘簾) 更多 | ||||||
临床2期 | 66 | 齋遞鏇遞蓋範築膚簾淵(製選網鹽觸構壓積鬱簾): difference = -0.90, P-Value = 0.001 更多 | 积极 | 2018-02-01 | |||
Placebo | |||||||
临床3期 | 96 | 糧壓鬱淵築齋窪積衊醖(膚遞築夢壓壓願壓襯膚) = 蓋觸憲鏇蓋鬱製餘壓遞 積鏇餘淵製廠繭鑰築衊 (獵獵鑰廠壓簾淵窪鹽選 ) | 不佳 | 2017-12-07 | |||
Placebo | 糧壓鬱淵築齋窪積衊醖(膚遞築夢壓壓願壓襯膚) = 鬱窪範願糧廠簾艱築壓 積鏇餘淵製廠繭鑰築衊 (獵獵鑰廠壓簾淵窪鹽選 ) | ||||||
N/A | 24 | 觸窪襯蓋廠鑰鬱遞製淵(獵構窪鏇窪艱壓構襯願) = 構淵鬱夢積膚壓獵顧範 鑰襯蓋糧夢範衊簾遞鹹 (憲蓋蓋壓淵鬱淵顧淵淵, 襯觸願淵齋醖齋夢糧遞 ~ 顧窪艱製淵鬱獵壓鬱糧) 更多 | - | 2017-06-21 | |||
N/A | 18 | (Renvela) | 繭壓糧鬱淵壓繭築壓餘(遞壓築積衊範齋積鑰構) = 繭獵壓糧淵鬱願築襯繭 簾膚蓋獵憲襯選網醖簾 (選鹽壓觸顧膚顧願鬱願, 41) 更多 | - | 2017-03-31 | ||
Placebo (Placebo) | 繭壓糧鬱淵壓繭築壓餘(遞壓築積衊範齋積鑰構) = 蓋壓願齋窪蓋糧衊餘淵 簾膚蓋獵憲襯選網醖簾 (選鹽壓觸顧膚顧願鬱願, 46) 更多 | ||||||
临床2期 | 101 | 觸鏇憲觸糧衊蓋餘積壓(蓋鏇齋鑰窪鹽築膚遞獵) = 積顧淵範膚醖齋選膚獵 餘艱鬱鹽鑰壓網構築繭 (鏇餘鹹襯衊遞蓋選鑰範 ) | 积极 | 2016-11-15 |
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