Sodium zirconium cyclosilicate

别名: Lokelma; 用于治疗高钾血症 (hyperkalaemia,血清中存在高水平的钾)。
目录号: V64483 纯度: ≥98%
环硅酸锆钠是一种口服、不可吸收的新型无机微孔硅酸锆化合物。
Sodium zirconium cyclosilicate CAS号: 17141-74-1
产品类别: Others 12
产品仅用于科学研究,不针对患者销售
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纯度/质量控制文件

纯度: ≥98%

产品描述
环硅酸锆钠是一种口服、不可吸收的新型无机微孔硅酸锆化合物。它是一种选择性阳离子交换剂,可以选择性地去除体内多余的K+。环硅酸锆钠可用于慢性肾病 (CKD) 研究。
生物活性&实验参考方法
体外研究 (In Vitro)
环硅酸锆钠 (ZS-9) 是一种结晶无机阳离子交换化合物,具有卓越的捕获单价阳离子的能力,特别是过量的 K+ 和铵离子。二价离子Ca2+和Mg2+对环硅酸锆钠的交换容量小于0.05 mEq/g,K+的选择性比Ca2+或Mg2+高25倍以上[1]。
体内研究 (In Vivo)
在Sprague-Dawley大鼠的粪便中,回收了环硅酸锆钠(ZS-9;2-6 g/kg;口服;每天,持续5 d),并且具有有效吸收和去除钾离子的作用[2]。
动物实验
动物/疾病模型: Sprague-Dawley 大鼠[2]
剂量: 2、4 和 6 g/kg
给药途径: 口服;每日一次,连续 5 天
实验结果: 大鼠粪便回收率达 99%。钾离子的吸收和清除呈剂量依赖性。
药代性质 (ADME/PK)
吸收、分布和排泄
环硅酸锆钠是一种无机不溶性化合物,不易被酶代谢。此外,研究表明它也不会被全身吸收。一项大鼠体内质量平衡研究表明,环硅酸锆钠存在于粪便中,没有全身吸收的证据。环硅酸锆钠主要通过粪便排出体外。
代谢/代谢物
环硅酸锆钠是一种无机不溶性化合物,不易被酶代谢。此外,研究表明它也不会被全身吸收。一项大鼠体内质量平衡研究显示,环硅酸锆钠存在于粪便中,没有全身吸收的证据。由于这些因素及其不溶性,迄今为止尚未开展任何体内或体外研究来考察其对细胞色素P450 (CYP450)酶或转运蛋白活性的影响。
参考文献

[1]. Characterization of structure and function of ZS-9, a K+ selective ion trap. PLoS One. 2014 Dec 22;9(12):e114686.

[2]. A phase 2 study on the treatment of hyperkalemia in patients with chronic kidney disease suggests that the selective potassium trap, ZS-9, is safe and efficient. Kidney Int. 2015 Aug;88(2):404-11.

其他信息
环硅酸锆钠(商品名:洛克玛)由阿斯利康公司研发,是一种不溶、不被吸收的硅酸锆钠,配制成口服混悬剂粉末,可作为高选择性钾离子清除剂。该药口服给药,无味、无臭,室温下稳定。三项双盲、安慰剂对照试验和两项开放标签试验的数据支持了该药的获批。数据显示,该药起效时间约为1小时,达到正常血钾水平的中位时间为2.2小时,92%的患者在给药后48小时内血钾水平恢复正常。治疗效果可持续长达12个月。环硅酸锆钠是一种不溶、不被吸收的无机物质,用作钾离子结合剂,用于治疗高钾血症。口服混悬液后,环硅酸锆钠可选择性地靶向并结合胃肠道中的钾离子,将其钠离子交换为钾离子。这可增加粪便中钾的排泄,降低胃肠道内游离钾的浓度,从而降低血清钾水平。
用于治疗高钾血症。
另见:环硅酸锆离子(具有活性部分)。
药物适应症
环硅酸锆钠是一种钾结合剂,适用于治疗成人高钾血症。
FDA标签
作用机制
高钾血症是指血液中钾含量升高的一种疾病,通常由心血管疾病、肾脏疾病和代谢性疾病引起。23%至47%的慢性肾脏病和/或慢性心力衰竭患者会出现高钾血症,并可能导致心脏骤停和死亡。锆硅酸钠环硅酸盐是一种不被吸收的非聚合物无机粉末,具有均匀的微孔结构,可优先捕获钾离子,并以氢离子和钠离子作为交换。锆硅酸钠环硅酸盐对钾离子具有高度选择性,即使在存在钙离子和镁离子等其他阳离子的情况下,体外实验也证实了这一点。锆硅酸钠环硅酸盐可在整个胃肠道中捕获钾离子,降低胃肠道腔内游离钾的浓度,从而降低血清钾水平并增加粪便钾的排泄,以缓解高钾血症。
药效学
服用环硅酸锆钠后,最快一小时即可降低血清钾浓度,通常在24至48小时内即可恢复正常血钾水平。环硅酸锆钠不影响血清钙、镁浓度或尿钠排泄。初始血清钾水平与疗效之间存在密切相关性;初始血清钾水平较高的患者,其血清钾降低幅度更大。由于血清钾浓度降低,尿钾排泄量也随之减少。一项针对健康受试者的研究显示,受试者每日服用5克或10克环硅酸锆钠,连续服用四天,结果显示血清钾浓度和总尿钾排泄量呈剂量依赖性降低,同时粪便钾排泄量平均增加。未观察到尿钠排泄量的统计学显著变化。体外和体内实验均观察到锆硅酸钠能够结合铵,从而清除铵并提高血清碳酸氢盐水平。接受锆硅酸钠治疗的患者,每日一次服用5克时,血清碳酸氢盐水平升高1.1 mmol/L;每日一次服用10克时,升高2.3 mmol/L;每日一次服用15克时,升高2.6 mmol/L,而安慰剂组患者的平均升高幅度为0.6 mmol/L。在其他影响肾素和醛固酮的因素未得到控制的情况下,与安慰剂组(升高14%)相比,锆硅酸钠可使平均血清醛固酮水平降低,且降低幅度与剂量无关(降低幅度为-30%至-31%)。目前尚未观察到锆硅酸钠对收缩压和舒张压的持续影响。此外,与安慰剂组(0.8 mg/dL)和低剂量环硅酸锆钠组(0.3 mg/dL)相比,每日三次服用 5 克(-1.1 mg/dL)和 10 克(-2.0 mg/dL)组的血尿素氮(BUN)平均略有增加。
*注: 文献方法仅供参考, InvivoChem并未独立验证这些方法的准确性
化学信息 & 存储运输条件
分子式
H6O9SI3.2NA.ZR
分子量
371.50
精确质量
363.769
CAS号
17141-74-1
PubChem CID
155804812
外观&性状
Typically exists as solid at room temperature
tPSA
166
氢键供体(HBD)数目
0
可旋转键数目(RBC)
0
重原子数目
15
分子复杂度/Complexity
131
定义原子立体中心数目
0
SMILES
[O-][Si]1(O[Si](O[Si](O1)([O-])[O-])([O-])[O-])[O-].[Na+].[Na+].[Zr+4]
InChi Key
QMLIRKACNOVYNW-UHFFFAOYSA-N
InChi Code
InChI=1S/2Na.O9Si3.Zr/c;;1-10(2)7-11(3,4)9-12(5,6)8-10;/q2*+1;-6;+4
化学名
disodium;2,2,4,4,6,6-hexaoxido-1,3,5,2,4,6-trioxatrisilinane;zirconium(4+)
HS Tariff Code
2934.99.9001
存储方式

Powder      -20°C    3 years

                     4°C     2 years

In solvent   -80°C    6 months

                  -20°C    1 month

注意: 请将本产品存放在密封且受保护的环境中,避免吸湿/受潮。
运输条件
Room temperature (This product is stable at ambient temperature for a few days during ordinary shipping and time spent in Customs)
溶解度数据
溶解度 (体外实验)
May dissolve in DMSO (in most cases), if not, try other solvents such as H2O, Ethanol, or DMF with a minute amount of products to avoid loss of samples
溶解度 (体内实验)
注意: 如下所列的是一些常用的体内动物实验溶解配方,主要用于溶解难溶或不溶于水的产品(水溶度<1 mg/mL)。 建议您先取少量样品进行尝试,如该配方可行,再根据实验需求增加样品量。

注射用配方
(IP/IV/IM/SC等)
注射用配方1: DMSO : Tween 80: Saline = 10 : 5 : 85 (如: 100 μL DMSO 50 μL Tween 80 850 μL Saline)
*生理盐水/Saline的制备:将0.9g氯化钠/NaCl溶解在100 mL ddH ₂ O中,得到澄清溶液。
注射用配方 2: DMSO : PEG300Tween 80 : Saline = 10 : 40 : 5 : 45 (如: 100 μL DMSO 400 μL PEG300 50 μL Tween 80 450 μL Saline)
注射用配方 3: DMSO : Corn oil = 10 : 90 (如: 100 μL DMSO 900 μL Corn oil)
示例: 注射用配方 3 (DMSO : Corn oil = 10 : 90) 为例说明, 如果要配制 1 mL 2.5 mg/mL的工作液, 您可以取 100 μL 25 mg/mL 澄清的 DMSO 储备液,加到 900 μL Corn oil/玉米油中, 混合均匀。
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注射用配方 4: DMSO : 20% SBE-β-CD in Saline = 10 : 90 [如:100 μL DMSO 900 μL (20% SBE-β-CD in Saline)]
*20% SBE-β-CD in Saline的制备(4°C,储存1周):将2g SBE-β-CD (磺丁基-β-环糊精) 溶解于10mL生理盐水中,得到澄清溶液。
注射用配方 5: 2-Hydroxypropyl-β-cyclodextrin : Saline = 50 : 50 (如: 500 μL 2-Hydroxypropyl-β-cyclodextrin (羟丙基环胡精) 500 μL Saline)
注射用配方 6: DMSO : PEG300 : Castor oil : Saline = 5 : 10 : 20 : 65 (如: 50 μL DMSO 100 μL PEG300 200 μL Castor oil 650 μL Saline)
注射用配方 7: Ethanol : Cremophor : Saline = 10: 10 : 80 (如: 100 μL Ethanol 100 μL Cremophor 800 μL Saline)
注射用配方 8: 溶解于Cremophor/Ethanol (50 : 50), 然后用生理盐水稀释。
注射用配方 9: EtOH : Corn oil = 10 : 90 (如: 100 μL EtOH 900 μL Corn oil)
注射用配方 10: EtOH : PEG300Tween 80 : Saline = 10 : 40 : 5 : 45 (如: 100 μL EtOH 400 μL PEG300 50 μL Tween 80 450 μL Saline)


口服配方
口服配方 1: 悬浮于0.5% CMC Na (羧甲基纤维素钠)
口服配方 2: 悬浮于0.5% Carboxymethyl cellulose (羧甲基纤维素)
示例: 口服配方 1 (悬浮于 0.5% CMC Na)为例说明, 如果要配制 100 mL 2.5 mg/mL 的工作液, 您可以先取0.5g CMC Na并将其溶解于100mL ddH2O中,得到0.5%CMC-Na澄清溶液;然后将250 mg待测化合物加到100 mL前述 0.5%CMC Na溶液中,得到悬浮液。
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口服配方 3: 溶解于 PEG400 (聚乙二醇400)
口服配方 4: 悬浮于0.2% Carboxymethyl cellulose (羧甲基纤维素)
口服配方 5: 溶解于0.25% Tween 80 and 0.5% Carboxymethyl cellulose (羧甲基纤维素)
口服配方 6: 做成粉末与食物混合


注意: 以上为较为常见方法,仅供参考, InvivoChem并未独立验证这些配方的准确性。具体溶剂的选择首先应参照文献已报道溶解方法、配方或剂型,对于某些尚未有文献报道溶解方法的化合物,需通过前期实验来确定(建议先取少量样品进行尝试),包括产品的溶解情况、梯度设置、动物的耐受性等。

请根据您的实验动物和给药方式选择适当的溶解配方/方案:
1、请先配制澄清的储备液(如:用DMSO配置50 或 100 mg/mL母液(储备液));
2、取适量母液,按从左到右的顺序依次添加助溶剂,澄清后再加入下一助溶剂。以 下列配方为例说明 (注意此配方只用于说明,并不一定代表此产品 的实际溶解配方):
10% DMSO → 40% PEG300 → 5% Tween-80 → 45% ddH2O (或 saline);
假设最终工作液的体积为 1 mL, 浓度为5 mg/mL: 取 100 μL 50 mg/mL 的澄清 DMSO 储备液加到 400 μL PEG300 中,混合均匀/澄清;向上述体系中加入50 μL Tween-80,混合均匀/澄清;然后继续加入450 μL ddH2O (或 saline)定容至 1 mL;

3、溶剂前显示的百分比是指该溶剂在最终溶液/工作液中的体积所占比例;
4、 如产品在配制过程中出现沉淀/析出,可通过加热(≤50℃)或超声的方式助溶;
5、为保证最佳实验结果,工作液请现配现用!
6、如不确定怎么将母液配置成体内动物实验的工作液,请查看说明书或联系我们;
7、 以上所有助溶剂都可在 Invivochem.cn网站购买。
制备储备液 1 mg 5 mg 10 mg
1 mM 2.6918 mL 13.4590 mL 26.9179 mL
5 mM 0.5384 mL 2.6918 mL 5.3836 mL
10 mM 0.2692 mL 1.3459 mL 2.6918 mL

1、根据实验需要选择合适的溶剂配制储备液 (母液):对于大多数产品,InvivoChem推荐用DMSO配置母液 (比如:5、10、20mM或者10、20、50 mg/mL浓度),个别水溶性高的产品可直接溶于水。产品在DMSO 、水或其他溶剂中的具体溶解度详见上”溶解度 (体外)”部分;

2、如果您找不到您想要的溶解度信息,或者很难将产品溶解在溶液中,请联系我们;

3、建议使用下列计算器进行相关计算(摩尔浓度计算器、稀释计算器、分子量计算器、重组计算器等);

4、母液配好之后,将其分装到常规用量,并储存在-20°C或-80°C,尽量减少反复冻融循环。

计算器

摩尔浓度计算器可计算特定溶液所需的质量、体积/浓度,具体如下:

  • 计算制备已知体积和浓度的溶液所需的化合物的质量
  • 计算将已知质量的化合物溶解到所需浓度所需的溶液体积
  • 计算特定体积中已知质量的化合物产生的溶液的浓度
使用摩尔浓度计算器计算摩尔浓度的示例如下所示:
假如化合物的分子量为350.26 g/mol,在5mL DMSO中制备10mM储备液所需的化合物的质量是多少?
  • 在分子量(MW)框中输入350.26
  • 在“浓度”框中输入10,然后选择正确的单位(mM)
  • 在“体积”框中输入5,然后选择正确的单位(mL)
  • 单击“计算”按钮
  • 答案17.513 mg出现在“质量”框中。以类似的方式,您可以计算体积和浓度。

稀释计算器可计算如何稀释已知浓度的储备液。例如,可以输入C1、C2和V2来计算V1,具体如下:

制备25毫升25μM溶液需要多少体积的10 mM储备溶液?
使用方程式C1V1=C2V2,其中C1=10mM,C2=25μM,V2=25 ml,V1未知:
  • 在C1框中输入10,然后选择正确的单位(mM)
  • 在C2框中输入25,然后选择正确的单位(μM)
  • 在V2框中输入25,然后选择正确的单位(mL)
  • 单击“计算”按钮
  • 答案62.5μL(0.1 ml)出现在V1框中
g/mol

分子量计算器可计算化合物的分子量 (摩尔质量)和元素组成,具体如下:

注:化学分子式大小写敏感:C12H18N3O4  c12h18n3o4
计算化合物摩尔质量(分子量)的说明:
  • 要计算化合物的分子量 (摩尔质量),请输入化学/分子式,然后单击“计算”按钮。
分子质量、分子量、摩尔质量和摩尔量的定义:
  • 分子质量(或分子量)是一种物质的一个分子的质量,用统一的原子质量单位(u)表示。(1u等于碳-12中一个原子质量的1/12)
  • 摩尔质量(摩尔重量)是一摩尔物质的质量,以g/mol表示。
/

配液计算器可计算将特定质量的产品配成特定浓度所需的溶剂体积 (配液体积)

  • 输入试剂的质量、所需的配液浓度以及正确的单位
  • 单击“计算”按钮
  • 答案显示在体积框中
动物体内实验配方计算器(澄清溶液)
第一步:请输入基本实验信息(考虑到实验过程中的损耗,建议多配一只动物的药量)
第二步:请输入动物体内配方组成(配方适用于不溶/难溶于水的化合物),不同的产品和批次配方组成不同,如对配方有疑问,可先联系我们提供正确的体内实验配方。此外,请注意这只是一个配方计算器,而不是特定产品的确切配方。
+
+
+

计算结果:

工作液浓度 mg/mL;

DMSO母液配制方法 mg 药物溶于 μL DMSO溶液(母液浓度 mg/mL)。如该浓度超过该批次药物DMSO溶解度,请首先与我们联系。

体内配方配制方法μL DMSO母液,加入 μL PEG300,混匀澄清后加入μL Tween 80,混匀澄清后加入 μL ddH2O,混匀澄清。

(1) 请确保溶液澄清之后,再加入下一种溶剂 (助溶剂) 。可利用涡旋、超声或水浴加热等方法助溶;
            (2) 一定要按顺序加入溶剂 (助溶剂) 。

临床试验信息
Title:Comparison of Potassium Binders in the ER
Status:Terminated
updateDate:2026-04-22
Ctid:NCT04585542

Link: https://clinicaltrials.gov/ct2/show/NCT04585542

Conditions:Acute Hyperkalemia|Oral Potassium Binders
Interventions:Sodium zirconium cyclosilicate
Phase:Phase 4
Title:A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients
Status:Recruiting
updateDate:2026-03-04
Ctid:NCT06578078

Link: https://clinicaltrials.gov/ct2/show/NCT06578078

Conditions:Heart Failure|Chronic Kidney Diseases
Interventions:Standard of care treatment (RAASi therapy)
Phase:Phase 3
Title:A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia
Status:Terminated
updateDate:2026-01-08
Ctid:NCT05056727

Link: https://clinicaltrials.gov/ct2/show/NCT05056727

Conditions:Renal Insufficiency, Chronic|Hyperkalemia
Interventions:Irbesartan
Phase:Phase 3
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Title:A National, Multicenter, Prospective, Observational Study to Assess Patient Characteristics, Treatment Algorithms and Disease Management of Hyperkalaemia Patients With Chronic Kidney Disease or Under Dialysis or With Heart Failure, Treated With Sodium Zirconium Cyclosilicate in Greece
Status:Completed
updateDate:2025-12-30
Ctid:NCT06185660

Link: https://clinicaltrials.gov/ct2/show/NCT06185660

Conditions:Hyperkalaemia
Interventions:sodium zirconium cyclosilicate (SZC)
Phase:
Title:Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study
Status:Completed
updateDate:2025-11-28
Ctid:NCT05347693

Link: https://clinicaltrials.gov/ct2/show/NCT05347693

Conditions:Hyperkalaemia|Chronic Kidney Disease
Interventions:Local standard of care
Phase:Phase 4
Title:Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone
Status:Completed
updateDate:2025-07-09
Ctid:NCT04676646

Link: https://clinicaltrials.gov/ct2/show/NCT04676646

Conditions:Hyperkalaemia|Heart Failure With Reduced Ejection Fraction
Interventions:Placebo
Phase:Phase 4
Title:OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure
Status:Active, not recruiting
updateDate:2025-07-04
Ctid:NCT04789239

Link: https://clinicaltrials.gov/ct2/show/NCT04789239

Conditions:Heart Failure|Hyperkalemia
Interventions:Sodium zirconium cyclosilicate
Phase:Phase 2
Title:Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
Status:Terminated
updateDate:2025-06-18
Ctid:NCT04847232

Link: https://clinicaltrials.gov/ct2/show/NCT04847232

Conditions:Hyperkalemia
Interventions:SZC Placebo
Phase:Phase 3
Title:The ORTIZ Study: Optimising RASi Therapy With SZC
Status:Terminated
updateDate:2025-06-08
Ctid:NCT04983979

Link: https://clinicaltrials.gov/ct2/show/NCT04983979

Conditions:CKD|Diabetes Mellitus, Type 2|Hyperkalemia
Interventions:Placebo
Phase:Phase 2
Title:A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia.
Status:Completed
updateDate:2025-05-14
Ctid:NCT03528681

Link: https://clinicaltrials.gov/ct2/show/NCT03528681

Conditions:Hyperkalemia
Interventions:Placebo
Phase:Phase 3
Title:Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4
Status:Unknown status
updateDate:2025-03-06
Ctid:NCT06365684

Link: https://clinicaltrials.gov/ct2/show/NCT06365684

Conditions:Hyperkalemia|Diet Modification|Chronic Kidney Disease|Sodium Zirconium Cyclosilicate
Interventions:Sodium zirconium cyclosilicate
Phase:Phase 4
Title:SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients
Status:Completed
updateDate:2025-02-11
Ctid:NCT06029179

Link: https://clinicaltrials.gov/ct2/show/NCT06029179

Conditions:Hyperkalemia
Interventions:sodium polystyrene sulfonate
Phase:N/A
Title:the Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients
Status:Not yet recruiting
updateDate:2024-12-16
Ctid:NCT06736184

Link: https://clinicaltrials.gov/ct2/show/NCT06736184

Conditions:Chronic Kidney Disease on Hemodialysis|Hypokalemia|Hyperkalemia|Myocardial Injury
Interventions:Sodium Zirconium Cyclosilicate (SZC)
Phase:Phase 4
Title:Keeping RAASi Treatment With Optimal Potassium Control
Status:Recruiting
updateDate:2024-08-29
Ctid:NCT06578533

Link: https://clinicaltrials.gov/ct2/show/NCT06578533

Conditions:Chronic Kidney Diseases
Interventions:Sodium Zirconium Cyclosilicate
Phase:Phase 3
Title:Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects
Status:Completed
updateDate:2024-04-05
Ctid:NCT04788641

Link: https://clinicaltrials.gov/ct2/show/NCT04788641

Conditions:Hyperkalaemia
Interventions:Sodium Zirconium Cyclosilicate
Phase:Phase 1
Title:Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease
Status:Terminated
updateDate:2023-10-06
Ctid:NCT04727528

Link: https://clinicaltrials.gov/ct2/show/NCT04727528

Conditions:Hyperkalaemia|Metabolic Acidosis|Chronic Kidney Disease
Interventions:Placebo
Phase:Phase 3
Title:Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects
Status:Completed
updateDate:2023-03-28
Ctid:NCT04217590

Link: https://clinicaltrials.gov/ct2/show/NCT04217590

Conditions:Hyperkalemia
Interventions:Placebo
Phase:Phase 3
Title:Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia
Status:Terminated
updateDate:2023-01-19
Ctid:NCT04997161

Link: https://clinicaltrials.gov/ct2/show/NCT04997161

Conditions:Hyperkalaemia
Interventions:Sodium Zirconium Cyclosilicate (SZC)
Phase:Phase 4
Title:Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy
Status:Completed
updateDate:2022-05-19
Ctid:NCT05382988

Link: https://clinicaltrials.gov/ct2/show/NCT05382988

Conditions:Sodium Zirconium Cyclosilicate|Hyperkalemia|Hyperparathyroidism, Secondary
Interventions:Sodium zirconium cyclosilicate
Phase:Phase 3
Title:Potassium Reduction Initiative to Optimize RAAS Inhibition Therapy With Sodium Zirconium Cyclosilicate in Heart Failure
Status:Terminated
updateDate:2021-06-15
Ctid:NCT03532009

Link: https://clinicaltrials.gov/ct2/show/NCT03532009

Conditions:Heart Failure
Interventions:Placebo
Phase:Phase 2
Title:A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.
Status:Completed
updateDate:2020-02-20
Ctid:NCT03303521

Link: https://clinicaltrials.gov/ct2/show/NCT03303521

Conditions:Hyperkalemia
Interventions:Sodium Zirconium Cyclosilicate (ZS)
Phase:Phase 3
Title:A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8
Status:Completed
updateDate:2020-01-28
Ctid:NCT03337477

Link: https://clinicaltrials.gov/ct2/show/NCT03337477

Conditions:Hyperkalemia
Interventions:Glucose
Phase:Phase 2
Title:Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.
Status:Completed
updateDate:2018-12-07
Ctid:NCT02088073

Link: https://clinicaltrials.gov/ct2/show/NCT02088073

Conditions:Hyperkalemia
Interventions:Placebo
Phase:Phase 3
Title:Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.
Status:Completed
updateDate:2018-08-15
Ctid:NCT02107092

Link: https://clinicaltrials.gov/ct2/show/NCT02107092

Conditions:Hyperkalemia
Interventions:Sodium Zirconium Cyclosilicate
Phase:Phase 3
Title:Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months
Status:Completed
updateDate:2018-06-27
Ctid:NCT02163499

Link: https://clinicaltrials.gov/ct2/show/NCT02163499

Conditions:Hyperkalemia
Interventions:Sodium Zirconium Cyclosilicate
Phase:Phase 3
Title:A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)
Status:Completed
updateDate:2017-12-19
Ctid:NCT03283267

Link: https://clinicaltrials.gov/ct2/show/NCT03283267

Conditions:Hyperkalemia
Interventions:Sodium Zirconium Cyclosilicate (ZS)
Phase:Phase 1
Title:OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosili-cate in Heart Failure (OPRA-HF)
Status:Trial now transitioned
Date:2021-01-14
Eudractnumber:2020-005176-35

Link: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2020-005176-35

Condition:Heart failure
Phase:Phase 2
Title:Healthy diet rich in potassium containing fruits, vegetables and nuts to chronic kidney disease patients thought the use of sodium zirconium cyclosilicate: A Feasibility Study
Status:Prematurely Ended
Date:2020-06-12
Eudractnumber:2020-000695-38

Link: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2020-000695-38

Condition:Chronic kidney disease, stages 4 and 5 of the disease
Phase:Phase 4
Title:A randomized, double-blind, placebo controlled, parallel, multicentre study of the effects of 12-weeks of sodium zirconium cyclosilicate (Lokelma) on albuminuria (UACR) in patients with diabetes and hyperkalemia
Status:Prematurely Ended
Date:2019-07-08
Eudractnumber:2019-000595-42

Link: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-000595-42

Condition:Treatment for proteinuria in type 1 or type 2 diabetes with hyperkalemia
Phase:Phase 4
Title:A Phase 3, Dose-Escalating Study in Children With Hyperkalaemia Between Birth and <18 Years of Age to Evaluate Increasing Doses of Sodium Zirconium Cyclosilicate (SZC) Given Three Times Daily for the Correction of Hyperkalaemia and the Effectiveness of the Same Dose of SZC Given Once Daily to Maintain Normokalaemia Among Those Requiring Continuous Treatment.
Status:Trial now transitioned, GB - no longer in EU/EEA, Ongoing
Date:2019-03-18
Eudractnumber:2018-001331-48

Link: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2018-001331-48

Condition:Hyperkalaemia
Phase:Phase 3
Title:A Phase II, Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicentre, Three Month Duration Potassium Reduction Initiative to Optimize RAAS Inhibition Therapy with Sodium Zirconium Cyclosilicate in Heart Failure (PRIORITIZE HF)
Status:Prematurely Ended
Date:2018-06-21
Eudractnumber:2018-000175-33

Link: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2018-000175-33

Condition:Heart Failure;Hyperkalaemia
Phase:Phase 2
Title:A phase 3b, multicenter, prospective, randomized, double blind, placebocontrolled
Status:Completed
Date:2018-02-09
Eudractnumber:2017-003029-14

Link: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-003029-14

Condition:Hyperkalemia among patients on stable hemodialysis (pre-dialysis serum K >5.4 mmol/L after long inter-dialytic interval and >5.0 mmol/L after one short inter-dialytic interval)
Phase:Phase 3
Title:A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ENERGIZE)
Status:Prematurely Ended
Date:2017-12-21
Eudractnumber:2017-003955-50

Link: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-003955-50

Condition:Hyperkalemia requiring urgent therapy (serum potassium more than or equal to 5.8mmol/L).
Phase:Phase 2

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