Drugs / Lanthanum Carbonate

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) FOSRENOL 2004-10-26 fda.gov

Trials 29 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 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
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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.

FieldValueCited text
Known as Lanthanum Carbonate “Changes With Lanthanum Carbonate, Calcium Acetate, and Phosphorus Restriction in CKD: A Randomized Controlled Trial.” PMID 29989014 Mar 2018
38

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

NCT01696279

NCT00438932

NCT04485039

NCT03136705

NCT00150566

NCT02258074

NCT04440696

NCT00785629

NCT00160121

NCT00452478

NCT01845090

NCT00841126

NCT00234702

NCT03346369

NCT00925704

NCT02209636

NCT00441545

NCT01128179

NCT01581996

NCT02237534

NCT01341678

NCT00880750

NCT00843349

NCT00151918

NCT01289626

NCT00150540

NCT00151931

NCT01578200

NCT01518387

NCT00875017

NCT00767637

NCT01514851

NCT00660530

NCT01002872

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

NCT01187628

NCT01110629

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