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Ferric citrate for reducing cardiac failure in chronic kidney disease patients

A chronic kidney disease, iron citrate technology, applied in metabolic diseases, urinary system diseases, organic active ingredients, etc., can solve the lack of dialysis center infrastructure, poor intravenous iron administration equipment, and CKD iron deficiency patients. Intravenous iron therapy, etc.

Inactive Publication Date: 2016-08-17
KERYX BIOPHARMLS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Additionally, many CKD clinics, especially community sites, are poorly equipped for IV iron administration because they lack infrastructure for dialysis centers
This leaves the majority of CKD iron deficient patients without access to IV iron therapy

Method used

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  • Ferric citrate for reducing cardiac failure in chronic kidney disease patients
  • Ferric citrate for reducing cardiac failure in chronic kidney disease patients
  • Ferric citrate for reducing cardiac failure in chronic kidney disease patients

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0316] Phase 3 58-week trial of ferric citrate as a phosphate binder in patients on dialysis with end-stage renal disease (ESRD)

[0317] The main objectives of the trial are as follows:

[0318] 1. To determine the long-term safety of KRX-0502 (ferric citrate) up to twelve (12) caplets / day over 52 weeks in patients with end-stage renal disease undergoing hemodialysis or peritoneal dialysis.

[0319] 2. To determine the efficacy of KRX-0502 (ferric citrate) during the 4-week randomized open-label placebo-controlled efficacy evaluation period.

[0320] Research rationale

[0321] A previous clinical trial demonstrated the ability of ferric citrate to reduce serum phosphorus levels in ESRD patients undergoing thrice-weekly hemodialysis. These trials used a maximum of about 12 g / day ferric citrate for 4 weeks.

[0322] This clinical trial measured ferric citrate during a 56-week treatment period when compared with placebo during a 52-week safety evaluation period and a randomi...

Embodiment 2

[0484] Study of KRX-0502 (ferric citrate) in the management of serum phosphorus and iron deficiency in anemic subjects with stage III-V chronic kidney disease not on dialysis

[0485] A phase 2 proof-of-concept multicenter randomized placebo-controlled open-label clinical trial was conducted.

[0486] The study lasts approximately 5-7 months with approximately 8-12 weeks allocated for subject screening, 2 weeks for subjects to wash off their existing phosphate binders (if taking), and 12 weeks allocated for administration of study drug For treatment, the research drug was ferric citrate or placebo disclosed herein. For the purposes of this example, the ferric citrate disclosed herein is referred to as KRX-0502 (ferric citrate).

[0487]The objective of the study was to determine the efficacy and safety of KRX-0502 (ferric citrate) in the management of serum phosphorus and iron deficiency in anemic subjects with non-dialysis-dependent stage III-V chronic kidney disease (CKD). ...

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PUM

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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, reduce the need for erythropoiesis-stimulating agents (ESAs), and / or reduce mortality and morbidity related to adverse cardiac events in chronic kidney disease patients, are disclosed.

Description

[0001] This application claims priority to US Provisional Application Serial No. 61 / 899,866, filed November 4, 2013, which is incorporated herein in its entirety. field of invention [0002] The methods and compositions disclosed herein generally relate to the use of ferric citrate to treat patients with chronic kidney disease (CKD) and related complications. Background of the invention [0003] Chronic kidney disease (CKD) is the gradual and progressive loss of the kidneys' ability to secrete waste products, concentrate urine, and preserve electrolytes. The U.S. National Kidney Foundation defines chronic kidney disease according to the presence or absence of kidney damage and the level of kidney function regardless of the type of kidney disease (clinical diagnosis). The primary measure of renal function is the glomerular filtration rate (GFR), which is often assessed as creatinine clearance from serum and urine creatinine concentration. Chronic kidney disease or failure wa...

Claims

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Application Information

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IPC IPC(8): A61K31/295
CPCA61K33/26A61P13/12A61P3/12A61P9/00A61P9/04A61P9/06A61P9/10A61K9/20
Inventor 恩里克·普拉多苏罗恩·本图尔詹姆斯·F·奥利维耶罗三世
Owner KERYX BIOPHARMLS
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