Hyperkalemia
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CLINICAL_TRIALS trial_result · 2021-03-25Clinical Trial Update: Exploratory Study of ZG-801 for the Treatment of Hyperkalemia [Phase 2]
Exploratory Phase 2 study evaluating ZG-801 for the treatment of hyperkalemia has been completed.
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CLINICAL_TRIALS trial_result · 2020-08-19Clinical Trial Update: A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia [Phase 3]
Phase 3 clinical trial investigating the safety and efficacy of ZS in patients with hyperkalemia has completed with results posted.
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CLINICAL_TRIALS trial_result · 2020-05-01Clinical Trial Update: Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia [Phase 3]
Open-label safety study of sodium zirconium cyclosilicate in Japanese adults with hyperkalemia, up to 12 months (Phase 3; completed).
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FDA approval · 2020-04-24FDA Approved: LOKELMA — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for LOKELMA (sodium zirconium cyclosilicate) from AstraZeneca Pharmaceuticals LP.
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CLINICAL_TRIALS trial_result · 2020-04-13Clinical Trial Update: Pharmacokinetic Study of Tacrolimus and Mycophenolate Mofetil in Kidney Transplant Recipients With Hyperkalemia Receiving Patiromer [Phase 4]
Phase 4 pharmacokinetic study evaluating tacrolimus and mycophenolate mofetil in kidney transplant recipients with hyperkalemia treated with…
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FDA approval · 2020-02-25FDA Approved: SODIUM POLYSTYRENE SULFONATE — Supplemental Application (PuraCap Laboratories, LLC)
FDA approves a supplemental application for sodium polystyrene sulfonate from PuraCap Laboratories, LLC.
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FDA approval · 2020-02-21FDA Approved: SODIUM POLYSTYRENE SULFONATE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for Sodium polystyrene sulfonate by Chartwell RX, LLC under the referenced ANDA.
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FDA approval · 2020-02-21FDA Approved: SODIUM POLYSTYRENE SULFONATE — Supplemental Application (KVK-Tech, Inc.)
FDA approves a supplemental application for sodium polystyrene sulfonate submitted by KVK-Tech, Inc.
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FDA approval · 2020-02-21FDA Approved: SODIUM POLYSTYRENE SULFONATE — Supplemental Application (SUNRISE PHARMACEUTICAL, INC.)
FDA approved a supplemental application for Sodium Polystyrene Sulfonate from Sunrise Pharmaceutical, Inc., resulting in an approved generic…
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CLINICAL_TRIALS trial_result · 2020-02-20Clinical Trial Update: A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients. [Phase 3]
Phase 3 trial assessing whether ZS (Sodium Zirconium Cyclosilicate) reduces episodes of high potassium in dialyzed patients with hyperkalemi…
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CLINICAL_TRIALS trial_result · 2020-01-28Clinical Trial Update: A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8 [Phase 2]
Phase 2 trial evaluating a potassium normalization regimen including sodium zirconium cyclosilicate in patients with hyperkalemia; study com…
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CLINICAL_TRIALS trial_result · 2020-01-27Clinical Trial Update: Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease [Phase 2]
Phase 2 trial evaluating spironolactone in combination with patiromer for resistant hypertension in chronic kidney disease; results posted i…
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CLINICAL_TRIALS trial_result · 2019-05-20Clinical Trial Update: ZS Ph2/3 Dose-response Study in Japan [Phase 2, Phase 3]
Clinical trial update for a dose-response study in Japan across Phase 2/3 for hyperkalemia; study completed with results posted in 2019.
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CLINICAL_TRIALS trial_result · 2018-12-07Clinical Trial Update: Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia. [Phase 3]
Phase 3 clinical trial update on the safety and efficacy of zirconium silicate for 28 days in hyperkalemia.
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CLINICAL_TRIALS trial_result · 2018-10-12Clinical Trial Update: Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia [Phase 3]
A Phase 3 trial reports safety and efficacy results for zirconium silicate in treating mild to moderate hyperkalemia. Completion and results…
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CLINICAL_TRIALS trial_result · 2018-08-15Clinical Trial Update: Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia. [Phase 3]
Open-label Phase 3 trial update evaluating safety and efficacy of ZS (Sodium Zirconium Cyclosilicate) 10g once daily to extend the ZS-004 st…
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CLINICAL_TRIALS trial_result · 2018-06-29Clinical Trial Update: Safety & Efficacy of Zirconium Silicate in Chronic Kidney Disease or Moderate Kidney Dysfunction With Mild Hyperkalemia [Phase 2]
Phase 2 study evaluating the safety and efficacy of sodium zirconium cyclosilicate (Lokelma) in patients with chronic kidney disease or mode…
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CLINICAL_TRIALS trial_result · 2018-06-27Clinical Trial Update: Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months [Phase 3]
An open-label Phase 3 trial evaluating the safety and efficacy of Sodium Zirconium Cyclosilicate for up to 12 months in patients with hyperk…
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FDA approval · 2018-05-18FDA Approved: LOKELMA — Original Application (AstraZeneca Pharmaceuticals LP)
FDA approved LOKELMA (sodium zirconium cyclosilicate) through its original NDA for the treatment of hyperkalemia.
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FDA approval · 2018-05-02FDA Approved: VELTASSA — Supplemental Application (Vifor Pharma, Inc.)
FDA approved a supplemental application for VELTASSA (patiromer) from Vifor Pharma, Inc., authorizing changes related to its labeling/indica…
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CLINICAL_TRIALS trial_result · 2017-11-20Clinical Trial Update: Patiromer With or Without Food for the Treatment of Hyperkalemia [Phase 4]
Phase 4 clinical trial evaluating patiromer with or without food for treatment of hyperkalemia has completed; results posted in 2017.
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CLINICAL_TRIALS trial_result · 2017-07-31Clinical Trial Update: The Effect of Mannitol on the Serum Potassium During Craniotomy
A completed clinical trial evaluated how Mannitol given during craniotomy influences serum potassium levels and related adverse reactions in…
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CLINICAL_TRIALS trial_result · 2017-06-23Clinical Trial Update: POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study
This completed multicenter, prospective observational study by ZS Pharma examined potassium levels and cardiac rhythm trends in adults on ma…
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FDA approval · 2017-06-15FDA Approved: CALCIUM GLUCONATE — Original Application (Fresenius Kabi USA, LLC)
The FDA approved Fresenius Kabi USA, LLC's calcium gluconate product under an original NDA.
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CLINICAL_TRIALS trial_result · 2017-06-08Clinical Trial Update: REal World EVidence for TrEAtment of HyperkaLemia in Emergency Department: Multicenter, Prospective, Observational Study
A multicenter, prospective observational study completed to evaluate real-world treatment approaches for hyperkalemia in the emergency depar…