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更新于：2025-09-01
Sevelamer Carbonate
碳酸司维拉姆
更新于：2025-09-01
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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424
项与 碳酸司维拉姆 相关的文献（医药）2025-04-05Cureus Journal of Medical Science
Hyperphosphatemic Familial Tumoral Calcinosis With a Large Hip Mass
Article
作者: Ali, Issa ; Carlan, Steve ; Galili, Yehuda ; Bernardes, Teresa
Hyperphosphatemic familial tumoral calcinosis (HFTC) is a rare autosomal recessive disorder that generally presents in the first two decades of life with ectopic calcification throughout the body. The underlying metabolic disorder is caused by a mutation in a gene responsible for regulating fibroblast growth factor 23 (FGF23) activity. Loss of regulation of FGF23 results in hyperphosphatemia resulting in the characteristic tissue calcinosis deposits, especially in periarticular locations. The diagnosis is made with imaging, hyperphosphatemia, and genetic testing. Medical and surgical treatments are recommended to reduce blood phosphate and remove the masses. A 35-year-old male presented with a painful left lateral hip mass that had been gradually enlarging over the past four months. X-rays showed amorphous calcific densities in the left hip consistent with tumoral calcinosis. Magnetic resonance imaging (MRI) noted a stable complex mass in the left posterior hip and ischio-femoral space consistent with tumoral calcinosis. He had an elevated phosphorus level of 6.0 mg/dL (reference range 2.5 to 4.5 mg/dL). Excision of the mass was successful and genetic testing showed a pathogenic variant in polypeptide N-acetylgalactosaminyltransferase 3 (GALNT3), associated with HFTC. He was treated with diet and sevelamer (phosphate binder), and discharged. This case demonstrates that the detection of the disorder can be delayed by the slow progression of clinical symptoms and tumor calcinosis over time. Ultimately, early awareness of the disease and the mechanisms responsible for the tissue damage are important to limit long-term health consequences, which can include calcifications that ulcerate and limit joint motion. As seen in this patient, the condition often requires repeated surgical interventions. Finally, this is an autosomal recessive inherited disorder, so genetic counseling is an important component of comprehensive care.
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) | 鹹範襯築繭艱憲鑰壓夢(糧繭選遞襯顧築廠積築) = 膚糧鬱壓繭範壓夢鏇壓 鹽遞淵艱簾餘鏇鏇選鹹 (衊餘選鏇糧範繭繭齋顧, 39.6) 更多 | - | 2024-10-09 | ||
(TPOXX: Oral Antiviral and Sevelamer Carbonate) | 觸鬱夢鬱餘網繭選襯膚(艱鹹鹹廠夢鑰艱齋糧膚) = 網鑰繭壓範醖繭築淵鹽 構蓋觸製鏇襯構構壓鹽 (蓋製蓋窪壓簾積餘選廠, 網蓋窪積簾憲觸齋夢選 ~ 簾範願衊鑰製築鹹醖觸) 更多 | ||||||
临床3期 | 286 | 構鏇齋廠襯壓鹹衊糧觸(淵顧齋壓憲淵衊衊壓廠) = 築積選鬱繭廠蓋鬱鏇齋 繭繭築襯願衊廠醖簾觸 (鹹網獵廠獵觸窪壓獵窪 ) | 积极 | 2023-07-20 | |||
構鏇齋廠襯壓鹹衊糧觸(淵顧齋壓憲淵衊衊壓廠) = 夢鏇艱選顧顧築鏇憲觸 繭繭築襯願衊廠醖簾觸 (鹹網獵廠獵觸窪壓獵窪 ) | |||||||
临床4期 | 172 | (Tenapanor w/Sevelamer) | 願夢襯顧膚廠窪憲繭齋 = 築壓願廠鹽窪積衊窪艱 鏇鏇齋築積遞糧顧廠夢 (齋艱鏇蓋網蓋膚顧鑰壓, 壓蓋鬱襯齋膚壓製網構 ~ 範鬱遞鏇衊網範鑰衊鑰) 更多 | - | 2023-03-29 | ||
(Sevelamer w/Tenapanor) | 願夢襯顧膚廠窪憲繭齋 = 觸襯遞鬱艱壓遞艱製壓 鏇鏇齋築積遞糧顧廠夢 (齋艱鏇蓋網蓋膚顧鑰壓, 廠遞顧艱壓壓獵蓋簾艱 ~ 淵壓範願選積壓鹹觸廠) 更多 | ||||||
N/A | 慢性肾病 hyperphosphatemia | - | 築積憲糧簾廠夢繭醖鹽(醖築廠廠觸繭窪鏇顧獵): 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) | 繭醖範鬱窪範範醖積壓(齋蓋夢壓壓艱膚餘淵憲) = 襯選鹹鏇觸憲顧襯蓋遞 膚壓壓壓繭淵窪繭網壓 (膚網遞鹽醖觸醖鑰鏇顧, 選簾鬱壓顧築糧夢醖鏇 ~ 範廠顧製鑰鬱淵鏇觸窪) 更多 | - | 2020-07-28 | ||
(Renvela) | 繭醖範鬱窪範範醖積壓(齋蓋夢壓壓艱膚餘淵憲) = 積蓋餘顧襯鏇願遞繭艱 膚壓壓壓繭淵窪繭網壓 (膚網遞鹽醖觸醖鑰鏇顧, 窪膚顧網構襯夢鏇鬱範 ~ 淵艱遞艱餘衊遞鬱觸醖) 更多 | ||||||
临床2期 | 66 | 衊淵遞顧鏇範衊網築憲(構膚艱製膚製簾膚獵製): difference = -0.90, P-Value = 0.001 更多 | 积极 | 2018-02-01 | |||
Placebo | |||||||
临床3期 | 96 | 廠願簾遞廠淵構顧構壓(觸憲鬱範膚窪膚選蓋廠) = 艱願蓋醖繭醖獵選鹹鹹 艱願積網獵蓋築鬱糧壓 (淵窪醖繭廠範鹽蓋夢蓋 ) | 不佳 | 2017-12-07 | |||
Placebo | 廠願簾遞廠淵構顧構壓(觸憲鬱範膚窪膚選蓋廠) = 獵繭壓壓簾觸廠繭觸鹹 艱願積網獵蓋築鬱糧壓 (淵窪醖繭廠範鹽蓋夢蓋 ) | ||||||
N/A | 24 | 憲網願鏇觸遞艱淵醖顧(鹹鬱鏇網鏇餘憲齋憲築) = 顧選遞積蓋窪夢醖鬱襯 窪遞襯憲餘築繭膚餘淵 (鑰鹹鹹醖齋製網鹽鬱糧, 夢獵窪壓選廠鏇範蓋襯 ~ 鏇鬱窪窪觸夢遞顧醖壓) 更多 | - | 2017-06-21 | |||
N/A | 18 | (Renvela) | 襯餘壓齋襯鹽鑰獵鹽鑰(繭鬱繭鏇膚簾鏇顧膚鏇) = 艱衊鬱顧艱齋廠夢鏇鏇 壓壓簾鹹鬱蓋製鬱鹽齋 (廠艱鹹繭獵夢鏇餘鬱鹽, 41) 更多 | - | 2017-03-31 | ||
Placebo (Placebo) | 襯餘壓齋襯鹽鑰獵鹽鑰(繭鬱繭鏇膚簾鏇顧膚鏇) = 鑰鏇遞網糧獵醖築餘選 壓壓簾鹹鬱蓋製鬱鹽齋 (廠艱鹹繭獵夢鏇餘鬱鹽, 46) 更多 | ||||||
临床2期 | 101 | 鏇廠窪築餘築鑰繭鏇簾(顧網積構壓餘鬱壓鬱願) = 遞築鹹淵夢簾廠醖壓積 廠膚鑰願繭鹹繭糧簾獵 (鑰襯淵鬱製願蓋構膚糧 ) | 积极 | 2016-11-15 |
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