Hyperphosphatemia
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CLINICAL_TRIALS trial_result · 2022-01-13Clinical Trial Update: Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients [Phase 4]
Clinical trial update on transitioning to ferric citrate for hyperphosphatemia in dialysis patients (Phase 4) with completed results.
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CLINICAL_TRIALS trial_result · 2022-01-11Clinical Trial Update: Clinical Study of KHK7791 in Hyperphosphatemia Patients on Peritoneal Dialysis [Phase 3]
Phase 3 trial update for KHK7791 in hyperphosphatemia patients on peritoneal dialysis has completed.
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FDA approval · 2022-01-07FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Bionpharma Inc.)
FDA approved a supplemental application for Sevelamer Carbonate submitted by Bionpharma Inc.
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CLINICAL_TRIALS trial_result · 2021-10-28Clinical Trial Update: Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis [Phase 3]
Phase 3 trial update for KHK7791 phosphate binder combo in hyperphosphatemia patients on hemodialysis has completed.
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CLINICAL_TRIALS trial_result · 2021-09-08Clinical Trial Update: Clinical Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis [Phase 3]
A Phase 3 clinical trial evaluating KHK7791 in patients with hyperphosphatemia on hemodialysis has completed.
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CLINICAL_TRIALS trial_result · 2021-07-28Clinical Trial Update: To Evaluate the Patient Tolerance, Pharmacodynamics and Pharmacokinetics of Lanthanum Polystyrene Sulfonate Powder [Phase 1, Phase 2]
Phase 1/2 clinical trial evaluating tolerance, pharmacodynamics, and pharmacokinetics of lanthanum polystyrene sulfonate powder for hyperpho…
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CLINICAL_TRIALS trial_result · 2021-06-02Clinical Trial Update: PA21 Safety and Efficacy in Adult Chinese Subjects [Phase 3]
Phase 3 clinical trial update evaluating PA21 safety and efficacy in adult Chinese subjects with chronic kidney disease on dialysis and hype…
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FDA approval · 2021-05-17FDA Approved: SEVELAMER CARBONATE — Original Application (Bionpharma Inc.)
FDA approved the original application for sevelamer carbonate from Bionpharma Inc., a generic phosphate binder for managing hyperphosphatemi…
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FDA approval · 2021-03-10FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Ferric Citrate from Mylan Pharmaceuticals, approving a supplemental NDA for the product (NDA…
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CLINICAL_TRIALS trial_result · 2021-03-10Clinical Trial Update: Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis [Phase 3]
A Phase 3 clinical trial evaluating ferric citrate for treating hyperphosphatemia in patients with chronic kidney disease on hemodialysis ha…
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CLINICAL_TRIALS trial_result · 2021-02-25Clinical Trial Update: Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia [Phase 4]
A Phase 4 trial comparing lanthanum versus calcium carbonate for vascular abnormalities in patients with chronic kidney disease and hyperpho…
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FDA approval · 2021-01-04FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for Sevelamer Carbonate by Amneal Pharmaceuticals LLC.
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FDA approval · 2020-12-28FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Exelan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Sevelamer carbonate submitted by Exelan Pharmaceuticals Inc.
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CLINICAL_TRIALS trial_result · 2020-12-19Clinical Trial Update: Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients [Phase 3]
Phase 3 trial comparing placebo to SBR759 for lowering phosphate in dialysis patients has completed.
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CLINICAL_TRIALS trial_result · 2020-12-19Clinical Trial Update: Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis [Phase 2]
Phase 2 trial update on SBR759 showing efficacy in lowering serum phosphate in chronic kidney disease patients on hemodialysis.
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FDA approval · 2020-11-20FDA Approved: SEVELAMER CARBONATE — Original Application (Amneal Pharmaceuticals of New York LLC)
FDA approved Amneal Pharmaceuticals of New York LLC's generic sevelamer carbonate for the management of hyperphosphatemia in patients with c…
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FDA approval · 2020-11-17FDA Approved: CALCIUM ACETATE — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for calcium acetate capsules (667 mg) by Rising Pharma Holdings, Inc.
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CLINICAL_TRIALS trial_result · 2020-10-01Clinical Trial Update: Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients [Phase 2]
A Phase 2 clinical trial comparing chewed versus crushed lanthanum carbonate in hemodialysis patients with hyperphosphatemia has completed, …
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CLINICAL_TRIALS research · 2020-09-14Clinical Trial Update: Dose Finding Study to Treat High Phosphate Levels in the Blood. [Phase 2]
A Phase 2 dose-finding study for treating high phosphate levels in the blood (hyperphosphatemia) has been completed with results posted.
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FDA approval · 2020-08-11FDA Approved: SEVELAMER CARBONATE — Original Application (Zydus Lifesciences Limited)
FDA approved the original application for Sevelamer carbonate by Zydus Lifesciences Limited.
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CLINICAL_TRIALS trial_result · 2020-08-10Clinical Trial Update: An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD) [Phase 3]
A Phase 3 trial evaluating tenapanor for hyperphosphatemia in ESRD patients on hemodialysis has completed and posted results in 2020.
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CLINICAL_TRIALS trial_result · 2020-07-28Clinical Trial Update: Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China [Phase 3]
A Phase 3 trial evaluating Renvela for hyperphosphatemia in chronic kidney disease patients not on dialysis in China has completed with resu…
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FDA approval · 2020-05-11FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for FOSRENOL (lanthanum carbonate) from Takeda Pharmaceuticals America, expanding its labeling.
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FDA approval · 2020-05-11FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for FOSRENOL (lanthanum carbonate) submitted by Takeda Pharmaceuticals America, Inc.
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FDA label_change · 2020-04-30FDA Approved: SEVELAMER HYDROCHLORIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)
The FDA approved a supplemental application for sevelamer hydrochloride (Sanofi) resulting in changes to the product’s labeling.