WO2013192565A3 - Use of ferric citrate in the treatment of chronic kidney disease patients - Google Patents

Use of ferric citrate in the treatment of chronic kidney disease patients Download PDF

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Publication number
WO2013192565A3
WO2013192565A3 PCT/US2013/047134 US2013047134W WO2013192565A3 WO 2013192565 A3 WO2013192565 A3 WO 2013192565A3 US 2013047134 W US2013047134 W US 2013047134W WO 2013192565 A3 WO2013192565 A3 WO 2013192565A3
Authority
WO
WIPO (PCT)
Prior art keywords
increase
iron
reduce
kidney disease
chronic kidney
Prior art date
Application number
PCT/US2013/047134
Other languages
French (fr)
Other versions
WO2013192565A2 (en
Inventor
Enrique Poradosu
Ron BENTSUR
James F. OLIVIERO III
Original Assignee
Keryx Biopharmaceuticals, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to EP23219273.2A priority Critical patent/EP4335436A3/en
Priority to CN201380044271.0A priority patent/CN104884055A/en
Application filed by Keryx Biopharmaceuticals, Inc. filed Critical Keryx Biopharmaceuticals, Inc.
Priority to EP13807102.2A priority patent/EP2863906B1/en
Priority to ES13807102T priority patent/ES2796254T3/en
Priority to JP2015518623A priority patent/JP2015535209A/en
Priority to KR1020157001458A priority patent/KR102150135B1/en
Priority to CA2876982A priority patent/CA2876982A1/en
Priority to AU2013278000A priority patent/AU2013278000A1/en
Priority to KR1020207024260A priority patent/KR20200103855A/en
Priority to EP20163104.1A priority patent/EP3730136B1/en
Priority to EA201590062A priority patent/EA201590062A1/en
Priority to MX2014015615A priority patent/MX2014015615A/en
Priority to SG11201408521WA priority patent/SG11201408521WA/en
Priority to BR112014032049A priority patent/BR112014032049A2/en
Publication of WO2013192565A2 publication Critical patent/WO2013192565A2/en
Priority to IL236356A priority patent/IL236356A0/en
Publication of WO2013192565A3 publication Critical patent/WO2013192565A3/en
Priority to HK15110673.6A priority patent/HK1210013A1/en
Priority to HK16102352.0A priority patent/HK1214503A1/en
Priority to AU2018203205A priority patent/AU2018203205B2/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/28Compounds containing heavy metals
    • A61K31/295Iron group metal compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/26Iron; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule

Abstract

Methods of administering ferric citrate to reduce and/or control serum phosphorus levels, increase serum bicarbonate levels, improve one or more iron storage parameters (e.g., increase serum ferritin levels, increase transferrin saturation (TSAT), increase hemoglobin concentration) increase iron absorption, maintain iron stores, treat iron deficiency, treat anemia, reduce the need for IV iron and/or reduce the need for erythropoiesis-stimulating agents (ESAs) in chronic kidney disease patients, are disclosed.
PCT/US2013/047134 2012-06-21 2013-06-21 Use of ferric citrate in the treatment of chronic kidney disease patients WO2013192565A2 (en)

Priority Applications (18)

Application Number Priority Date Filing Date Title
EA201590062A EA201590062A1 (en) 2012-06-21 2013-06-21 APPLICATION OF LEMON-ACID IRON IN THE TREATMENT OF PATIENTS WITH CHRONIC RENOVAL INSUFFICIENCY
EP20163104.1A EP3730136B1 (en) 2012-06-21 2013-06-21 Use of ferric citrate in the treatment of chronic kidney disease patients
MX2014015615A MX2014015615A (en) 2012-06-21 2013-06-21 Use of ferric citrate in the treatment of chronic kidney disease patients.
CN201380044271.0A CN104884055A (en) 2012-06-21 2013-06-21 Use of ferric citrate in the treatment of chronic kidney disease patients
JP2015518623A JP2015535209A (en) 2012-06-21 2013-06-21 Use of ferric citrate in the treatment of patients with chronic kidney disease
KR1020157001458A KR102150135B1 (en) 2012-06-21 2013-06-21 Use of ferric citrate in the treatment of chronic kidney disease patients
CA2876982A CA2876982A1 (en) 2012-06-21 2013-06-21 Use of ferric citrate in the treatment of chronic kidney disease patients
AU2013278000A AU2013278000A1 (en) 2012-06-21 2013-06-21 Use of ferric citrate in the treatment of chronic kidney disease patients
KR1020207024260A KR20200103855A (en) 2012-06-21 2013-06-21 Use of ferric citrate in the treatment of chronic kidney disease patients
EP23219273.2A EP4335436A3 (en) 2012-06-21 2013-06-21 Use of ferric citrate in the treatment of chronic kidney disease patients
ES13807102T ES2796254T3 (en) 2012-06-21 2013-06-21 Use of ferric citrate in the treatment of patients with chronic kidney disease
EP13807102.2A EP2863906B1 (en) 2012-06-21 2013-06-21 Use of ferric citrate in the treatment of chronic kidney disease patients
SG11201408521WA SG11201408521WA (en) 2012-06-21 2013-06-21 Use of ferric citrate in the treatment of chronic kidney disease patients
BR112014032049A BR112014032049A2 (en) 2012-06-21 2013-06-21 ferric citrate and oral iron supplement
IL236356A IL236356A0 (en) 2012-06-21 2014-12-18 Use of ferric citrate in the treatment of chronic kidney disease patients
HK15110673.6A HK1210013A1 (en) 2012-06-21 2015-10-28 Use of ferric citrate in the treatment of chronic kidney disease patients
HK16102352.0A HK1214503A1 (en) 2012-06-21 2016-03-01 Use of ferric citrate in the treatment of chronic kidney disease patients
AU2018203205A AU2018203205B2 (en) 2012-06-21 2018-05-08 Use of ferric citrate in the treatment of chronic kidney disease patients

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US201261662565P 2012-06-21 2012-06-21
US61/662,565 2012-06-21
US201361757229P 2013-01-28 2013-01-28
US61/757,229 2013-01-28
US201361801050P 2013-03-15 2013-03-15
US201361800618P 2013-03-15 2013-03-15
US61/800,618 2013-03-15
US61/801,050 2013-03-15

Publications (2)

Publication Number Publication Date
WO2013192565A2 WO2013192565A2 (en) 2013-12-27
WO2013192565A3 true WO2013192565A3 (en) 2015-10-15

Family

ID=49769729

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2013/047134 WO2013192565A2 (en) 2012-06-21 2013-06-21 Use of ferric citrate in the treatment of chronic kidney disease patients

Country Status (17)

Country Link
US (3) US20130345303A1 (en)
EP (3) EP3730136B1 (en)
JP (4) JP2015535209A (en)
KR (2) KR102150135B1 (en)
CN (2) CN113244209A (en)
AU (2) AU2013278000A1 (en)
BR (1) BR112014032049A2 (en)
CA (1) CA2876982A1 (en)
DK (1) DK3730136T3 (en)
EA (1) EA201590062A1 (en)
ES (1) ES2796254T3 (en)
HK (2) HK1210013A1 (en)
IL (1) IL236356A0 (en)
MX (1) MX2014015615A (en)
PL (1) PL3730136T3 (en)
SG (2) SG10201805177PA (en)
WO (1) WO2013192565A2 (en)

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RU2563819C2 (en) 2009-07-21 2015-09-20 Керикс Байофармасьютикалз, Инк. Drug forms of iron (iii) citrate
TWI653043B (en) * 2012-12-20 2019-03-11 瑞士商伊蘭科動物健康公司 New use
WO2014197725A1 (en) 2013-06-05 2014-12-11 Tricida, Inc. Proton-binding polymers for oral administration
EP2856941B1 (en) * 2013-10-01 2020-11-25 Fresenius Medical Care Deutschland GmbH Method and apparatuses for determining a patient's daily loss of iron
SG11201603091QA (en) * 2013-11-04 2016-05-30 Keryx Biopharmaceuticals Inc Ferric citrate for reducing cardiac failure in chronic kidney disease patients
WO2015110968A1 (en) * 2014-01-23 2015-07-30 Lupin Limited Pharmaceutical grade ferric citrate and method for its production
WO2015198304A1 (en) 2014-06-22 2015-12-30 Dexcel Pharma Technologies Ltd. Pharmaceutical compositions comprising ferric citrate and methods for the production thereof
MA41150B1 (en) 2014-12-10 2020-06-30 Tricida Inc Proton-binding polymers for oral administration
CA2978073A1 (en) * 2015-03-04 2016-09-09 Keryx Biopharmaceuticals, Inc. Use of ferric citrate in the treatment of iron-deficiency anemia
CN104688706B (en) * 2015-04-01 2017-07-14 成都欣捷高新技术开发有限公司 A kind of high drug load, ferrum citricum composition of Fast Stripping and preparation method thereof
WO2016162794A1 (en) * 2015-04-08 2016-10-13 Leiutis Pharmaceuticals Pvt Ltd Pharmaceutical compositions of ferric citrate
WO2016162888A1 (en) * 2015-04-09 2016-10-13 Actavis Group Ptc Ehf. Process for preparing pharmaceutical grade ferric citrate
MA44875A (en) 2016-05-06 2019-03-13 Tricida Inc COMPOSITIONS FOR THE TREATMENT OF ACID BASIC DISORDERS
EP3685831A4 (en) 2017-09-19 2021-06-16 Japan Tobacco Inc. Use of ferric citrate in prevention and/or treatment of iron-deficiency anemia in hypermenorrhea patient and/or patient suffering from hypermenorrhea-associated gynecologic disease
AU2018360867A1 (en) 2017-11-03 2020-04-30 Tricida, Inc. Compositions for and method of treating acid-base disorders
WO2019236639A1 (en) * 2018-06-04 2019-12-12 Tricida, Inc. Method of treating acid-base disorders
WO2020089227A1 (en) 2018-10-29 2020-05-07 Pharmacosmos Holding A/S Treating iron deficiency with ferric carboxymaltose
WO2022150623A1 (en) 2021-01-08 2022-07-14 Akebia Therapeutics, Inc. Compounds and composition for the treatment of anemia
TW202313072A (en) 2021-05-27 2023-04-01 美商凱立克斯生物製藥股份有限公司 Pediatric formulations of ferric citrate
CN115024495B (en) * 2022-06-27 2024-03-22 北京金康普食品科技有限公司 Nutritional composition for improving calcium and phosphorus metabolism of nephrosis patient and application thereof

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WO1998026776A1 (en) * 1996-12-16 1998-06-25 Chen Hsing Hsu Method for treating renal failure
US20090186939A1 (en) * 2006-01-30 2009-07-23 Keith Chan Method of Treating Chronic Kidney Disease
WO2011011541A1 (en) * 2009-07-21 2011-01-27 Henry Trong Le Ferric citrate dosage forms

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WO1998026776A1 (en) * 1996-12-16 1998-06-25 Chen Hsing Hsu Method for treating renal failure
US20090186939A1 (en) * 2006-01-30 2009-07-23 Keith Chan Method of Treating Chronic Kidney Disease
WO2011011541A1 (en) * 2009-07-21 2011-01-27 Henry Trong Le Ferric citrate dosage forms

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C. BOND ET AL.: "A Meta-Aanalysis Of Ferric Citrate For Hyperphosphatemia: The Effect odf an Oral Iron-Containing Phospahte Binder on Serum Ferritin and Saturated Transferrin in Hemodialysis Patients", NEPHROLOGY DIALYSIS TRANSPLANTATION, vol. 27, no. S2, May 2012 (2012-05-01), pages ii490, XP002740672 *
K. UMANATH ET AL.: "Rationale and study design of a three-period, 58-week trial of ferric citrate as a phosphate binder in patients with ESDR on dialysis", HEMODIALYSIS INTERNATIONAL, vol. 17, 15 June 2012 (2012-06-15), pages 67 - 74, XP002740674 *
M. SIKA ET AL.: "A Dose-Ranging And Efficacy Phase 3 Trial Of Ferric Citrate (FC) As A Phosphate Binder In Dialysis Patients", AM. J. KIDNEY DIS., vol. 57, no. 4, 2011, pages A89, XP002740671 *
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Also Published As

Publication number Publication date
PL3730136T3 (en) 2024-03-25
KR20150036131A (en) 2015-04-07
AU2018203205A1 (en) 2018-05-31
EP2863906A2 (en) 2015-04-29
US20130345303A1 (en) 2013-12-26
ES2796254T3 (en) 2020-11-26
CN104884055A (en) 2015-09-02
MX2014015615A (en) 2015-03-20
CN113244209A (en) 2021-08-13
KR20200103855A (en) 2020-09-02
WO2013192565A2 (en) 2013-12-27
SG10201805177PA (en) 2018-07-30
JP2020100638A (en) 2020-07-02
BR112014032049A2 (en) 2017-07-25
EP2863906B1 (en) 2020-03-18
IL236356A0 (en) 2015-02-26
US20150079168A1 (en) 2015-03-19
AU2018203205B2 (en) 2020-03-12
JP2015535209A (en) 2015-12-10
HK1214503A1 (en) 2016-07-29
KR102150135B1 (en) 2020-08-31
CA2876982A1 (en) 2013-12-27
EA201590062A1 (en) 2016-02-29
JP2022070945A (en) 2022-05-13
EP3730136A1 (en) 2020-10-28
US20140234416A1 (en) 2014-08-21
HK1210013A1 (en) 2016-04-15
SG11201408521WA (en) 2015-01-29
DK3730136T3 (en) 2024-01-22
EP4335436A2 (en) 2024-03-13
EP3730136B1 (en) 2023-12-27
AU2013278000A1 (en) 2015-01-22
JP2018138562A (en) 2018-09-06
EP4335436A3 (en) 2024-05-15

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