Hyperphosphatemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-08-04FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Ferric Citrate filed by Mylan Pharmaceuticals, authorizing continued or expanded use of this…
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FDA approval · 2015-06-29FDA Approved: CALCIUM ACETATE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
The FDA approved a generic calcium acetate under an Original Application (ANDA 202315) from Heritage Pharmaceuticals (d/b/a Avet) to treat h…
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CLINICAL_TRIALS trial_result · 2015-06-10Clinical Trial Update: Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules [Phase 2, Phase 3]
The trial evaluated therapeutic equivalence between OsvaRen tablets and OsvaRen granules in hyperphosphatemia associated with chronic kidney…
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FDA approval · 2015-06-09FDA Approved: SEVELAMER HYDROCHLORIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for sevelamer hydrochloride (Renagel) submitted by Sanofi-Aventis U.S. LLC. The approval updates the…
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CLINICAL_TRIALS trial_result · 2015-05-27Clinical Trial Update: Safety and Tolerability Study of MCI-196 [Phase 3]
Phase 3 safety and tolerability study of MCI-196 in chronic kidney disease patients, including those not on dialysis and paediatric populati…
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CLINICAL_TRIALS trial_result · 2015-05-27Clinical Trial Update: Dose-finding Study of MCI-196 [Phase 3]
Phase 3 dose-finding study of MCI-196 sponsored by Tanabe Pharma has been terminated. The trial investigated MCI-196 in chronic kidney disea…
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CLINICAL_TRIALS trial_result · 2015-05-27Clinical Trial Update: Long-term Extension Study of MCI-196 [Phase 3]
A terminated Phase 3 long-term extension study of MCI-196 in chronic kidney disease patients; the trial status has been terminated.
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FDA approval · 2015-05-22FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Ferric Citrate from Mylan Pharmaceuticals, expanding the regulatory approval for the product.
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FDA approval · 2015-05-18FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application from Mylan Pharmaceuticals Inc. for Ferric Citrate, approving a generic version of the iron-based ph…
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CLINICAL_TRIALS trial_result · 2015-05-04Clinical Trial Update: Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis [Phase 3]
A Phase 3 long-term study in patients with chronic kidney disease and hyperphosphatemia on hemodialysis has completed.
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CLINICAL_TRIALS trial_result · 2015-04-03Clinical Trial Update: Long-term Study in Chronic Kidney Disease (Extension From Study 14817) [Phase 3]
This entry notes the completion of a long-term extension of a Phase 3 trial in hyperphosphatemia associated with chronic kidney disease spon…
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EMA withdrawal · 2015-04-01EMA Withdrawn: BindRen (colestilan) — Mitsubishi Pharma Europe Ltd
The EMA has withdrawn BindRen (colestilan) from the market in Europe.
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CLINICAL_TRIALS trial_result · 2015-03-24Clinical Trial Update: A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis [Phase 3]
A Phase 3 randomized, double-blind, placebo-controlled trial evaluating sevelamer carbonate for hyperphosphatemia in non-dialysis chronic ki…
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CLINICAL_TRIALS trial_result · 2015-03-23Clinical Trial Update: Post Authorisation Safety Study of Renvela® in Chronic Kidney Disease Patients Not on Dialysis With Hyperphosphataemia
Post-authorization safety study of Renvela (sevelamer carbonate) in chronic kidney disease patients not on dialysis with hyperphosphatemia h…
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CLINICAL_TRIALS trial_result · 2015-03-20Clinical Trial Update: An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis [Phase 3]
An open-label, dose-titration Phase 3 study evaluating sevelamer carbonate in hyperphosphatemic CKD patients not on dialysis has completed.
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CLINICAL_TRIALS trial_result · 2015-03-10Clinical Trial Update: Effect of Restriction of Foods Containing Phosphorus Additives [NA]
A completed clinical trial evaluating the impact of restricting foods containing phosphorus additives in patients with end-stage renal disea…
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CLINICAL_TRIALS trial_result · 2014-12-10Clinical Trial Update: A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis [Phase 3]
A 58-week Phase 3 trial evaluating the safety and efficacy of Ferric Citrate in patients with end-stage renal disease on dialysis for hyperp…
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CLINICAL_TRIALS trial_result · 2014-12-04Clinical Trial Update: A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease [Phase 3]
Phase 3 dose-ranging trial of ferric citrate (KRX-0502) in end-stage renal disease patients with hyperphosphatemia. Results from the study h…
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FDA approval · 2014-11-26FDA Approved: SEVELAMER HYDROCHLORIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for Sevelamer Hydrochloride by Sanofi-Aventis U.S. LLC.
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FDA approval · 2014-11-26FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for Sevelamer carbonate (Renvela), a phosphate binder used to control hyperphosphatemia in chronic k…
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FDA approval · 2014-11-26FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for Renvela (sevelamer carbonate) submitted by Sanofi-Aventis U.S. LLC.
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CLINICAL_TRIALS trial_result · 2014-11-18Clinical Trial Update: Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
Completed clinical trial evaluating a new formulation of ferric citrate (KRX-0502) for hyperphosphatemia in patients with end-stage renal di…
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FDA approval · 2014-11-15FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Ferric Citrate by Mylan Pharmaceuticals Inc.
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CLINICAL_TRIALS trial_result · 2014-10-23Clinical Trial Update: A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia [Phase 3]
Phase III, multicenter, double-blind, placebo-controlled withdrawal study in patients with hyperphosphatemia related to chronic kidney disea…
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CLINICAL_TRIALS trial_result · 2014-10-15Clinical Trial Update: Study in Chronic Kidney Disease (CKD) Not on Dialysis [Phase 3]
A Bayer-sponsored Phase 3 trial in chronic kidney disease patients not on dialysis evaluating treatment for hyperphosphatemia has completed.