Drugs / Sevelamer
Sevelamer
also known as
Sevelamer Hydrochloride · Renagel · Sevelamer HCl · Renvela · Sevelamer Carbonate · GZ419831 · RenagelR
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | RENAGEL | — | 2000-05-05 – 2007-10-19 | fda.gov ↗ |
| Approved | EU (EMA) | Renagel | — | 2000-01-28 | europa.eu ↗ |
| Approved | US (FDA) | RENAGEL | — | 1998-10-30 | fda.gov ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03305471 | Aug 2017 → Jan 2019 | hyperphosphatemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 26 trials · 2 missed | ||||||
| Phase 2 | NCT01968759 | Oct 2013 → Oct 2015 | chronic kidney disease | Mario Negri Institute for Pharmacological Research | Completed | Missed primary |
| Phase 2 | NCT00824460 | Dec 2008 → Oct 2009 | chronic kidney disease | Vifor Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00690937 | Feb → Dec 2008 | hyperlipidemia | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 2 | NCT00440648 | Mar 2005 → Mar 2006 | chronic kidney disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 2 | NCT00324376 | Mar 2003 → May 2004 | chronic kidney disease | Genzyme, a Sanofi Company | Completed | Missed primary |
| Phase 2 | NCT00560300 | Nov 2000 → Nov 2006 | renal osteodystrophy | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 35 trials · 1 met primary | ||||||
| Phase 3 | NCT03202407 | Aug 2017 → Aug 2018 | hyperphosphatemia | Assiut University | Unknown | No outcome recorded |
| Phase 3 | NCT03001011 | Jun 2017 → Aug 2019 | hyperphosphatemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT02199444 | Jun 2014 → May 2015 | chronic kidney disease | Federico II University | Unknown | No outcome recorded |
| Phase 3 | NCT00267514 | Jan 2006 → Mar 2007 | chronic kidney disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT00196755 | Dec 2004 → Mar 2006 | chronic kidney disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT06660524 | Mar 2024 → Jun 2025 overdue | cardiac valvular defect, chronic kidney disease, heart valve disorder, mineral metabolism disease | China National Center for Cardiovascular Diseases | Recruiting | No outcome recorded |
| Phase 4 | NCT01135615 | Jan 2008 → Apr 2010 | — | Gulhane School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT01755078 | Jun 2007 → Jun 2009 | hyperphosphatemia | Chugai Pharma Taiwan | Completed | No outcome recorded |
| Phase 4 | NCT00324571 | Mar 2001 → Feb 2006 | chronic kidney disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 4 | NCT00486772 | — | vascular disorder | Gulhane School of Medicine | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT00364000 | Jan 2012 → Jul 2015 | hyperphosphatemia | Romanian Society of Nephrology | Withdrawn | No outcome recorded Stop: Business |
| — | NCT01238588 | Jun 2011 → Apr 2016 | atherosclerosis, hyperphosphatemia | Brigham and Women's Hospital | Terminated | No outcome recorded Stop: Business |
| — | NCT00837655 | Jan 2009 → Jun 2011 | chronic renal failure syndrome, end stage renal failure, hyperphosphatemia | Karolinska Institutet | Withdrawn | No outcome recorded |
| — | NCT00710788 | Jan 2007 → Sep 2010 | — | Azienda Sanitaria ASL Avellino 2 | Completed | No outcome recorded |
| — | NCT01049815 | Feb 2005 → Feb 2009 | end stage renal failure | Tel-Aviv Sourasky Medical Center | Completed | No outcome recorded |
| — | NCT00018135 | — | kidney failure | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Comparator or background therapy28 trials | ||||||
| Phase 1 | NCT00875017 Comparator | Apr → Jun 2009 | chronic renal failure syndrome | Shire | Completed | Met primary |
| Phase 1 | NCT00756860 Comparator | May → Aug 2008 | — | Amgen Research (Munich) GmbH | Completed | No outcome recorded |
| Phase 2 | NCT06906874 Background | Aug → Nov 2025 overdue | end stage renal failure, renal osteodystrophy | Mansoura University | Recruiting | No outcome recorded |
| Phase 2 | NCT02127125 Comparator | Apr 2014 → Sep 2018 | — | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 2 | NCT02124759 Comparator | Apr 2014 → Feb 2018 | — | The University of Texas Health Science Center at San Antonio | Completed | Missed primary |
| Phase 2 | NCT00853242 Comparator | Feb → Aug 2009 | chronic renal failure syndrome | Genzyme, a Sanofi Company | Completed | Met primary |
| Phase 2 | NCT00806481 Comparator | Feb 2009 → Oct 2011 | cardiovascular disorder, chronic kidney disease | University Hospital Birmingham NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT00704678 Comparator | Aug 2008 → Jun 2010 | chronic kidney disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT00704483 Comparator | Jul 2008 → Aug 2010 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00505037 Comparator | Oct 2007 → Sep 2008 | chronic kidney disease, hyperphosphatemia | Astellas Pharma Inc | Completed | Met primary |
| Phase 2 | NCT00436683 Comparator | Feb 2007 → Jan 2008 | chronic renal failure syndrome | Ineos Healthcare Limited | Completed | No outcome recorded |
| Phase 3 | NCT01850602 Comparator | Apr → Dec 2013 | hyperphosphatemia | Kissei Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT01057407 Comparator | Jan → Sep 2010 | chronic kidney disease, impaired renal function disease | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01011699 Comparator | Jan 2010 → Jun 2013 | chronic renal failure syndrome | Centre Hospitalier Universitaire, Amiens | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00844662 Comparator | Jul 2009 → Sep 2011 | chronic renal failure syndrome | Ineos Healthcare Limited | Terminated | No outcome recorded |
| Phase 3 | NCT00542815 Comparator | Nov 2007 → Aug 2010 | chronic kidney disease, hyperphosphatemia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00416520 Comparator | Jun 2007 → Nov 2009 | chronic kidney disease, hyperphosphatemia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00441545 Comparator | Jan 2007 → Jul 2008 | end stage renal failure | Shire | Completed | Missed primary |
| Phase 3 | NCT00268957 Comparator | Jan 2006 → Mar 2007 | chronic renal failure syndrome, end stage renal failure | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 4 | NCT03451019 Comparator | Mar 2018 → Dec 2020 | chronic kidney disease | Medical University of Lodz | Completed | No outcome recorded |
| Phase 4 | NCT03163576 Background | Jun 2017 → Jun 2019 | hyperphosphatemia | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT00211939 Comparator | Jan 2005 → Dec 2006 | arteriosclerosis disorder, calcinosis, secondary hyperparathyroidism | Nabi Biopharmaceuticals | Completed | No outcome recorded |
| — | NCT03739268 Comparator | Sep 2018 → Sep 2020 | type 2 diabetes mellitus | Steno Diabetes Center Copenhagen | Completed | No outcome recorded |
| — | NCT02822131 Background | Jan → Jun 2016 | hypertensive disorder | University of Zurich | Completed | No outcome recorded |
| — | NCT02445508 Comparator | May 2015 → Jul 2016 | type 2 diabetes mellitus | University Hospital, Gentofte, Copenhagen | Completed | No outcome recorded |
| — | NCT02273570 Background | Mar 2015 → Dec 2016 | secondary hyperparathyroidism of renal origin | Azienda Ospedaliera Sant'Anna | Unknown | No outcome recorded |
| — | NCT02061124 Comparator | Feb 2014 → Oct 2015 | type 2 diabetes mellitus | University Hospital, Gentofte, Copenhagen | Completed | No outcome recorded |
| — | NCT00745589 Comparator | Jul 2008 → Oct 2014 | end stage renal failure | The University of Hong Kong | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2021-06-17 | Lupin Limited | Regulatory Lupin Receives U.S. FDA Approval for Sevelamer Hydrochloride Tablets lupin.com ↗ |
All press releases naming this drug 12 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 51 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sevelamer | “Non-calcium containing phosphate binders, such as sevelamer and lanthanum, are expensive.” NCT03163576 ↗41“sevelamer("Renvela®"), calcium carbonate, calcium acetate("Phoslo®")” NCT02273570 ↗ “Sevelamer: (1.6 g sevelamer + 4.4 g maltodextrin three times a day)” NCT02124759 ↗ “calcium-based or non-calcium based (sevelamer) binders” NCT06906874 ↗ |
| Known as | GZ419831 | “Sevelamer Carbonate (GZ419831)” NCT03001011 ↗ |
| Known as | Renagel | “Calcium acetate, aluminum hydroxide, and sevelamer (Renagel) will be given on separate occasions in conjunction with a high phosphorus meal.” NCT00018135 ↗6“Patients were randomly assigned in 1:1 ratio to receive sevelamer (Renagel capsule) or calcium acetate (Phos Ex tablet).” NCT00486772 ↗ “Patients were randomly assigned in 1:1 ratio to receive sevelamer (Renagel capsule) or calcium acetate (Phos Ex tablet).” NCT01135615 ↗ “sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)” NCT00267514 ↗ “Sevelamer hydrochloride (Renagel®)” NCT00268957 ↗ “Sevelamer Hydrochloride (Renagel®)” NCT00196755 ↗ “Renagel® (sevelamer hydrochloride)” NCT00756860 ↗ |
| Known as | RenagelR | “label sevelamer (RenagelR) 800 mg tablets” NCT00364000 ↗ |
| Known as | Renvela | “sevelamer("Renvela®"), calcium carbonate, calcium acetate("Phoslo®")” NCT02273570 ↗1“sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)” NCT00267514 ↗ |
| Known as | Sevelamer Carbonate | “sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)” NCT00267514 ↗1“Sevelamer Carbonate (GZ419831)” NCT03001011 ↗ |
| Known as | Sevelamer HCl | “Sevelamer HCl regular treatment 1-3 tablets TID” NCT01755078 ↗ |
| Known as | Sevelamer Hydrochloride | “Sevelamer hydrochloride is a recently developed phosphate binder, which is a quaternary amine anion exchanger without calcium or aluminum.” NCT03202407 ↗11“compared with sevelamer hydrochloride in chronic kidney dialysis patients on hemodialysis.” PMID 21854503 ↗ Nov 2011 “sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)” NCT00267514 ↗ “Renagel® (sevelamer hydrochloride)” NCT00756860 ↗ “Drug: Sevelamer Hydrochloride” NCT03451019 ↗ |
| Modality | Other / unclassified | “sevelamer hydrochloride is a potent non-calcium-containing phosphate binder” NCT00364000 ↗ |
| Route | Oral | “administered orally with meals” NCT00441545 ↗ |