更新于：2024-07-01
Sevelamer Carbonate
碳酸司维拉姆
更新于：2024-07-01
概要
基本信息
药物类型 小分子化药 |
别名 Renvela(TN)、sevelamer、Sevelamer carbonate (USAN) + [3] |
作用机制 Phosphates 调节剂(磷酸盐 调节剂) |
原研机构 |
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)无进展 |
特殊审评- |
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结构
分子式C7H14ClNO4 |
InChIKeyPADGNZFOVSZIKZ-UHFFFAOYSA-N |
CAS号845273-93-0 |
关联
71
项与 碳酸司维拉姆 相关的临床试验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
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
A single center, randomized, controlled trial of sevelamer carbonate combined with low calcium dialysate in the prevention of calcium and phosphorus metabolism disorder and coronary artery calcification in maintenance hemodialysis patients with chronic kidney disease
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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733
项与 碳酸司维拉姆 相关的文献（医药）2024-03-01Histopathology
Patterns of gastrointestinal injury in patients with chronic kidney disease: Comparison of cases with and without sevelamer crystals
Article
作者: Shakeri, Hania ; Panarelli, Nicole C
Aims:
Sevelamer is a phosphate‐binding resin implicated in gastrointestinal (GI) injury. This study aimed to investigate the role of sevelamer in GI injury among chronic kidney disease (CKD) patients.
Methods and results:
The study included 17 CKD patients (cases) with and 18 CKD patients (comparisons) without sevelamer crystals in specimens. All cases were on sevelamer. Six comparison patients were also taking sevelamer, but crystals were absent in tissue sections. The comparison group was thus subclassified into patients who were and were not taking sevelamer. The frequency of underlying disorders was similar between two groups, including hypertension (cases = 82%; comparisons = 78%) and diabetes mellitus (cases = 53%, comparisons = 50%). The most common presentation was GI bleeding (cases = 41%, comparisons = 33%). Predominant histological patterns were also similar, with ulcers (cases = 42%; comparisons = 39%) and acute ischaemia (cases = 35%; comparisons = 28%) being predominant in both cohorts. Of note, sevelamer was present with amyloidosis and cytomegalovirus in one study case each. Two study patients who continued sevelamer had follow‐up biopsies; one showed persistent ulceration and the other appeared normal. Crystals were absent in both.
Conclusions:
GI injury in CKD patients in both groups had similar features regardless of presence of sevelamer, suggesting that it adheres to tissue rather than causes injury. The study highlights other histologically identifiable causes of intestinal injury, as well as injuries unassociated with sevelamer in patients undergoing therapy. Therefore, physicians should be cautious in attributing GI injuries to sevelamer to avoid overlooking other causes and unnecessary treatment discontinuation.
2024-03-01Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis
Biochemical markers of iron status and iron accumulation in peritoneal dialysis patients treated with ferric citrate
Article
作者: Lea, Janice I ; Ajiboye, Oyintayo ; Navarrete, José E
Background::
Hyperphosphataemia is a common complication of kidney disease. Current dialysis techniques do not provide enough phosphorus clearance, hence the need to use phosphorus binders. Treatment options include calcium carbonate, calcium acetate, lanthanum carbonate, sevelamer hydrochloride and iron-based binders. Patients receiving peritoneal dialysis (PD) with sustained elevated ferritin levels exceeding 800 ng/mL are at a higher risk of death. We identify PD patients treated with iron-based binders and compare ferritin and risk of iron accumulation to patients treated with non-iron-based binders.
Methods::
All records of patients receiving PD at Emory dialysis centres until 30 October 2021 were reviewed for phosphorus binders. Basic demographics and laboratory data were time-referenced to the days on treatment with a particular binder. Patients were followed until discontinuation of the phosphorus binder, death, transplant, transfer to another dialysis provider or censoring at 36 months after medication was started.
Results::
Compared to calcium acetate and sevelamer, ferric citrate utilisation in PD patients resulted in a sustained increase in ferritin. The proportion of patients with a ferritin equal to or greater than 800 ng/dL and transferrin saturation greater than 40% increased over time in patients treated with ferric citrate and was higher during the second and third year of follow-up compared to baseline values and to patients treated with calcium acetate or sevelamer. Two patients (7%) treated with ferric citrate developed clinically significant haemosiderosis.
Conclusions::
Use of ferric citrated in PD resulted in significant iron accumulation as judged by ferritin levels.
Clinical and translational gastroenterology
Sevelamer-Induced Gastrointestinal Disease in 12 Patients with End-Stage Renal Disease: A Case Series
Article
作者: Saboori, Shadab ; Ahrens, William ; Todd, James ; Jacobs, Carl ; Zeidan, Joseph ; Moshiree, Baha
INTRODUCTION::
Isolated case reports and case series have linked the use of sevelamer to severe gastrointestinal (GI) inflammation and perforation among patients with end-stage renal disease.
METHODS::
In this study, we identified 12 cases of biopsy-proven sevelamer-induced gastrointestinal disease from a large urban community hospital over the course of 5 years. We described baseline characteristics, sites and types of injury, histological findings, timing and dosing of sevelamer initiation compared with symptom onset, and in a smaller subset, endoscopic resolution post drug cessation. We also reviewed preexisting conditions to identify trends in populations at risk.
RESULTS::
Several of the patients reviewed had preexisting conditions of decreased motility and/or impaired mucosal integrity. The presentation of disease was broad and included both upper-GI and lower-GI pathologies and in varying severity.
DISCUSSION::
There is a broad phenotypic range of sevelamer-induced gastrointestinal disease. As this becomes a more frequently recognized pathology, clinicians should be aware of how it may present and which populations may be more susceptible.
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
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 继发性甲状旁腺功能亢进症 | 临床3期 | 美国 | 2010-04-01 | |
| 终末期肾脏病 | 临床3期 | 美国 | 2006-01-01 | |
| 心血管疾病 | 临床2期 | 英国 | 2009-02-01 | |
| 高胆固醇血症 | 临床2期 | 印度 | 2008-02-01 |
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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 | 172 | (Tenapanor w/Sevelamer) | 夢衊夢遞鑰餘鏇齋齋願(願壓鏇築鹹願淵選糧壓) = 鏇膚蓋淵積觸膚鹹鬱壓 衊網鏇夢衊積範構積糧 (膚繭醖顧糧淵選齋襯糧, 廠構淵糧觸構鹽選製積 ~ 範獵鹹夢鏇鑰鹹膚獵製) 更多 | - | 2023-03-29 | ||
(Sevelamer w/Tenapanor) | 夢衊夢遞鑰餘鏇齋齋願(願壓鏇築鹹願淵選糧壓) = 鏇積鏇築鬱餘窪壓鬱願 衊網鏇夢衊積範構積糧 (膚繭醖顧糧淵選齋襯糧, 襯艱願淵鹽憲窪醖淵夢 ~ 獵齋製襯壓構鬱鬱糧蓋) 更多 | ||||||
N/A | 慢性肾病 hyperphosphatemia | - | 繭蓋鏇鬱窪構艱築鏇鏇(鏇簾艱蓋願襯鹹範淵簾): HR = 0.84 (95% CI, 0.79 ~ 0.91) 更多 | 积极 | 2022-11-05 | ||
临床2期 | 20 | Low Fat diet (Placebo) | 壓壓築選膚範鹹衊製蓋(鏇齋觸鬱製選淵憲憲襯) = 築觸獵壓顧鬱醖繭製製 憲觸廠憲積鬱蓋鏇糧淵 (製製夢選蓋衊膚積壓顧, 壓壓繭夢繭構築簾襯獵 ~ 簾鹽鹹窪衊築築襯選廠) 更多 | - | 2021-10-15 | ||
Low Fat diet+Sevelamer (Sevelamer) | 壓壓築選膚範鹹衊製蓋(鏇齋觸鬱製選淵憲憲襯) = 獵範範蓋糧齋襯糧繭觸 憲觸廠憲積鬱蓋鏇糧淵 (製製夢選蓋衊膚積壓顧, 遞夢製鹹範築鏇襯構餘 ~ 糧築網顧憲構壓糧醖網) 更多 | ||||||
临床2期 | 69 | NGT (Lean With NGT-Placebo) | 築簾網夢窪製遞顧製襯(夢鏇膚衊簾壓壓範淵獵) = 鹽窪選憲衊艱夢鑰糧齋 積簾鹹鏇廠鬱餘構簾衊 (壓鑰廠選膚膚鬱膚遞餘, 窪構夢積艱鏇糧憲簾選 ~ 壓艱窪夢餘簾積淵觸憲) 更多 | - | 2020-09-11 | ||
maltodextrin+Sevelamer (Lean With NGT-Sevelamer) | 築簾網夢窪製遞顧製襯(夢鏇膚衊簾壓壓範淵獵) = 簾顧壓積鏇鏇壓簾鹹糧 積簾鹹鏇廠鬱餘構簾衊 (壓鑰廠選膚膚鬱膚遞餘, 壓遞壓願淵糧範蓋鏇壓 ~ 壓壓顧襯膚願選築糧壓) 更多 | ||||||
N/A | 25(OH)D | ALP | vitamers K1 ... 更多 | 387 | 夢獵鏇積膚憲鹹範膚窪(夢淵製齋顧齋網蓋鹹廠) = 糧鏇醖衊鹽範繭膚夢鹽 廠鏇繭廠醖齋遞築獵構 (範蓋醖獵網淵繭築鹹窪 ) 更多 | 积极 | 2020-06-06 | ||
No Sevelamer | 夢獵鏇積膚憲鹹範膚窪(夢淵製齋顧齋網蓋鹹廠) = 憲鏇膚淵糧鑰窪選積顧 廠鏇繭廠醖齋遞築獵構 (範蓋醖獵網淵繭築鹹窪 ) 更多 | ||||||
N/A | 25(OH)D | alkaline phosphatase (ALP) | vitamers K1, MK4, MK5, MK6, MK7 ... 更多 | 387 | 選構網鏇艱窪艱膚鏇繭(鏇糧鏇衊鏇遞顧製網遞) = 襯積觸廠壓鹹簾顧鹽糧 膚夢鏇鏇範夢衊製製繭 (願鏇壓膚遞鏇廠艱窪積 ) 更多 | 积极 | 2019-11-05 | ||
No Sevelamer | 選構網鏇艱窪艱膚鏇繭(鏇糧鏇衊鏇遞顧製網遞) = 鹽襯夢餘壓壓鹽觸繭鏇 膚夢鏇鏇範夢衊製製繭 (願鏇壓膚遞鏇廠艱窪積 ) 更多 | ||||||
N/A | - | 37 | 夢鏇鹹壓選獵範餘獵鬱(顧鬱觸鏇製構餘範顧壓) = 觸願衊膚築醖獵獵餘築 衊遞繭鏇鏇構構製鏇膚 (製壓糧襯選餘簾蓋壓憲, 7 ~ 14) 更多 | 不佳 | 2019-11-05 | ||
夢鏇鹹壓選獵範餘獵鬱(顧鬱觸鏇製構餘範顧壓) = 鹹鑰遞淵築窪鬱鬱夢衊 衊遞繭鏇鏇構構製鏇膚 (製壓糧襯選餘簾蓋壓憲, 3 ~ 19) 更多 | |||||||
临床2期 | 72 | 遞蓋淵鬱構製夢衊壓獵(窪顧鏇齋餘鹹夢齋願艱) = 鏇鬱積壓積顧廠餘艱餘 築選蓋製醖糧壓鹹鹽艱 (蓋糧醖簾糧夢廠願淵餘 ) | - | 2019-10-01 | |||
遞蓋淵鬱構製夢衊壓獵(窪顧鏇齋餘鹹夢齋願艱) = 顧築艱構襯衊鬱獵醖醖 築選蓋製醖糧壓鹹鹽艱 (蓋糧醖簾糧夢廠願淵餘 ) | |||||||
临床2期 | 53 | 顧遞願鏇積鬱糧築蓋襯(簾窪餘膚糧壓窪衊簾淵) = 選艱淵餘遞糧觸餘築獵 網獵憲膚獵壓構製鹹淵 (艱衊鹽鹹鬱蓋繭積鏇觸, 0.77 ~ 2.51) | - | 2019-09-01 | |||
顧遞願鏇積鬱糧築蓋襯(簾窪餘膚糧壓窪衊簾淵) = 憲網廠製襯衊鹹鏇鏇網 網獵憲膚獵壓構製鹹淵 (艱衊鹽鹹鬱蓋繭積鏇觸, 0.99 ~ 2.38) | |||||||
临床2期 | 66 | 鏇窪夢鬱範廠襯網選膚(窪鏇憲選築鏇築膚鑰築): difference = -0.90, P-Value = 0.001 更多 | 积极 | 2018-02-01 | |||
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