Ferric citrate

Overview

Tetraferric tricitrate decahydrate is an iron containing phosphate binder used to treat hyperphosphatemia and iron deficiency anemia in adults with chronic kidney disease. Tetraferric tricitrate decahydrate was granted FDA approval on 5 September 2014.

Indication

Tetraferric tricitrate decahydrate is indicated to control serum phosphorous in adults with chronic kidney disease who require dialysis. Tetraferric tricitrate decahydrate is also indicated to treat iron deficiency anemia in adults with chronic kidney disease who are not on dialysis.

Associated Conditions

Hyperphosphataemia
Iron Deficiency Anemia (IDA)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Ferric Citrate and Chronic Kidney Disease in Children	2021/02/05	NCT04741646	Phase 2	Recruiting	University of California, Los Angeles
Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease	2020/12/02	NCT04649411	Phase 3	Not yet recruiting	Keryx Biopharmaceuticals
PBF-1681 (Ferric Citrate) for the Treatment of IDA in Patients With NDD-CKD	2020/09/10	NCT04543812	Phase 3	Completed	Panion & BF Biotech Inc.
Study to Evaluate the Safety and Tolerability of Ferric Citrate in Children With Hyperphosphatemia Related to Chronic Kidney Disease	2020/08/24	NCT04523727	Phase 3	Recruiting	Keryx Biopharmaceuticals
Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat	2020/03/09	NCT04299633	Phase 1	Completed	Akebia Therapeutics
Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis	2019/06/13	NCT03984760	Phase 3	Completed	Panion & BF Biotech Inc.
Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis	2017/08/22	NCT03256838	Phase 4	Completed	Panion & BF Biotech Inc.
KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial)	2017/08/01	NCT03236246	Phase 4	Completed	Keryx Biopharmaceuticals
Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients	2017/03/15	NCT03079869	Phase 4	Completed	Kaiser Permanente
Ferric Citrate in ESRD Pilot Project	2017/02/16	NCT03055598	Phase 4	Active, not recruiting	Sreedhar Mandayam

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Auryxia	Akebia Therapeutics, Inc.	59922-631	ORAL	210 mg in 1 1	3/18/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Schuessler Tissue Salts Indigestion Comb E	120125	Martin & Pleasance Pty Ltd	Medicine	A	6/27/2005
Schuessler Tissue Salts Stomach Upset Comb S	120131	Martin & Pleasance Pty Ltd	Medicine	A	6/27/2005
Sun Ten Forsythia & Rhubarb Formula (Liang Ge San)	296813	Sun Ten Chinaherb Co (Aust) Pty Ltd	Medicine	A	11/27/2017
FANG FENG TONG SHENG WAN [ Siler & Platycodon Combination]	11677	Cathay Herbal Laboratories	Medicine	A	8/19/1991
Schuessler Tissue Salts General Tonic Comb 12	121322	Martin & Pleasance Pty Ltd	Medicine	A	8/16/2005
Schuessler Tissue Salts General Tonic Comb 12	121321	Martin & Pleasance Pty Ltd	Medicine	A	8/16/2005
Schuessler Tissue Salts Water Eliminator Nat Sulph	120629	Martin & Pleasance Pty Ltd	Medicine	A	7/18/2005
Schuessler Tissue Salts Water Eliminator Nat Sulph	108966	Martin & Pleasance Pty Ltd	Medicine	A	9/16/2004
Schuessler Tissue Salts Rheumatism Comb M	120130	Martin & Pleasance Pty Ltd	Medicine	A	6/27/2005
Schuessler Tissue Salts Acidity Comb C	120126	Martin & Pleasance Pty Ltd	Medicine	A	6/27/2005

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MULTI MINERALS CAPSULES	sisu inc.	00679003	Capsule - Oral	6 MG / CAP	12/31/1986

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

AI-Powered Research

Premium Access