Lanthanum Carbonate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | FOSRENOL | — | 2004-10-26 | fda.gov ↗ |
Trials 29 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT02952040 | Nov → Dec 2016 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01289626 | Feb 2011 → Mar 2013 | calciphylaxis | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 1 | NCT00925704 | Jun → Jul 2009 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT00875017 | Apr → Jun 2009 | chronic renal failure syndrome | Shire | Completed | No outcome recorded |
| Phase 1 | NCT00880750 | Jan → Jun 2009 | end stage renal failure | Shire | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT02258074 | Mar 2015 → Nov 2018 | chronic kidney disease | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 2 | NCT01696279 | Feb 2013 → Nov 2018 | chronic kidney disease, hyperphosphatemia | Shire | Completed | No outcome recorded |
| Phase 2 | NCT01128179 | Dec 2010 → Apr 2012 | chronic kidney disease | Shire | Completed | No outcome recorded |
| Phase 2 | NCT00234702 | Jan 2006 → Jun 2007 | chronic kidney disease | Shire | Completed | No outcome recorded |
| Phase 2 | NCT00767637 | Jun 2005 → Oct 2008 | hyperphosphatemia | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00769496 | Jan 2005 → May 2008 | hyperphosphatemia | Bayer | Completed | No outcome recorded |
| Phase 311 trials | ||||||
| Phase 3 | NCT03346369 | Aug 2017 → Dec 2022 | nephrolithiasis | University Hospital Brussels | Unknown | No outcome recorded |
| Phase 3 | NCT01578200 | Dec 2011 → Mar 2019 | hyperphosphatemia | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | Completed | No outcome recorded |
| Phase 3 | NCT01187628 | Sep 2010 → Apr 2013 | hyperphosphatemia | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01110629 | Jun 2010 → Nov 2011 | hyperphosphatemia | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00441545 | Jan 2007 → Jul 2008 | end stage renal failure | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01514851 | Jan → May 2006 | hyperphosphatemia | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01518387 | Jan → Jul 2006 | hyperphosphatemia | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00151918 | Jan → Aug 2005 | chronic renal failure syndrome | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00151931 | May 2004 → Jan 2006 | end stage renal failure | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00150566 | Feb 2004 → Oct 2005 | end stage renal failure | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00150540 | Oct 2002 → Jun 2005 | chronic renal failure syndrome | Shire | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT04485039 | Jun → Dec 2022 | smallpox | SIGA Technologies | Completed | No outcome recorded |
| Phase 4 | NCT02209636 | Sep 2014 → Jun 2019 | cardiovascular disorder, chronic kidney disease | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 4 | NCT02237534 | Sep 2014 → Mar 2023 | chronic kidney disease, hyperphosphatemia, metabolic bone disorder | Osaka University | Unknown | No outcome recorded |
| Phase 4 | NCT00452478 | May → Dec 2007 | kidney disorder | Shire | Terminated | No outcome recorded |
| Phase 4 | NCT00160121 | Jan → Dec 2005 | chronic renal failure syndrome | Shire | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01581996 | Mar 2012 → May 2017 | chronic renal failure syndrome, end stage renal failure | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Completed | No outcome recorded |
| — | NCT01341678 | Apr → Oct 2011 | chronic kidney disease | Geoffrey Block | Completed | No outcome recorded |
Also used as a comparator or background therapy in 11 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03136705 Comparator | Feb 2016 → Dec 2017 | — | Northwestern University | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04440696 Background | Oct 2020 → Jun 2022 | hyperphosphatemia | Grand Life Science (Liaoning) Co., Ltd. | Unknown | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00660530 Comparator | Jan 2008 → Nov 2009 | hyperphosphatemia, kidney disorder | University of Illinois at Chicago | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01357317 Comparator | Jun 2011 → Oct 2013 | chronic kidney disease | Salem Veterans Affairs Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT00841126 Comparator | Jul 2009 → Jul 2011 | chronic renal failure syndrome | Ineos Healthcare Limited | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01845090 Comparator | Aug 2011 → Jul 2014 | — | Camillians Saint Mary's Hospital Luodong | Unknown | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT02273570 Background | Mar 2015 → Dec 2016 | secondary hyperparathyroidism of renal origin | Azienda Ospedaliera Sant'Anna | Unknown | No outcome recorded |
| — | NCT01002872 Comparator | Oct 2009 → May 2012 | metabolic bone disorder | Endeavor Health | Completed | No outcome recorded |
| — | NCT00843349 Comparator | Jul 2009 → Feb 2012 | kidney disorder | Myles Wolf | Completed | No outcome recorded |
| — | NCT00785629 Comparator | Feb 2009 → Jul 2011 | chronic kidney disease | Denver Nephrologists, P.C. | Completed | No outcome recorded |
| — | NCT00438932 Comparator | Jan 2007 → Jan 2010 | chronic kidney disease | Massachusetts General Hospital | Completed | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 40 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lanthanum Carbonate | “Changes With Lanthanum Carbonate, Calcium Acetate, and Phosphorus Restriction in CKD: A Randomized Controlled Trial.” PMID 29989014 ↗ Mar 201838“lanthanum carbonate "Foznol®"). A rescue therapy with aluminum("Maalox®") is allowed” NCT02273570 ↗ “Fosrenol (Lanthanum Carbonate, BAY77-1931)” NCT01187628 ↗ “Fosrenol (Lanthanum Carbonate, BAY77-1931)” NCT01110629 ↗ “Lanthanum Carbonate (BAY 77-1931)” NCT00769496 ↗ |
| Known as | BAY77-1931 | “Fosrenol (Lanthanum Carbonate, BAY77-1931)” NCT01110629 ↗5“Fosrenol (Lanthanum Carbonate, BAY77-1931)” NCT01187628 ↗ “Lanthanum Carbonate (BAY 77-1931)” NCT00769496 ↗ “Lanthanum carbonate (BAY77-1931)” NCT01514851 ↗ “Lanthanum Carbonate (BAY77-1931)” NCT00767637 ↗ “Lanthanum Carbonate (BAY77-1931)” NCT01518387 ↗ |
| Known as | Fosrenol | “Fosrenol (lanthanum carbonate, manufactured by Shire Pharmaceuticals) is a gastrointestinal phosphate binder” NCT01581996 ↗5“Lanthanum carbonate (FOSRENOL®) is a potent non-aluminum, non-calcium phosphate binder” NCT01289626 ↗ “Lanthanum Carbonate (FOSRENOL®) or Sevelamer Carbonate (RENVELA®)” NCT00925704 ↗ “Fosrenol (Lanthanum carbonate)” NCT00441545 ↗ |
| Known as | Foznol | “lanthanum carbonate "Foznol®"). A rescue therapy with aluminum("Maalox®") is allowed” NCT02273570 ↗ |
| Known as | Lanthanum carbonate hydrate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02952040 ↗ |
| Modality | Other / unclassified | “Lanthanum carbonate is another efficacious and well-tolerated non-calcium phosphate binder.” NCT01578200 ↗ |
| Route | Oral | “Chewable tablets will be administered orally with meals.” NCT00441545 ↗ |