scholarly journals Safety and efficacy of ferric citrate in phosphate reduction and iron supplementation in patients with chronic kidney disease

Oncotarget ◽  
2017 ◽  
Vol 8 (63) ◽  
pp. 107283-107294 ◽  
Author(s):  
Mei-Yi Wu ◽  
Ying-Chun Chen ◽  
Chun-Hung Lin ◽  
Yun-Chun Wu ◽  
Yu-Kang Tu ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Iron Supplementation ◽  
Ferric Citrate ◽  
Safety And Efficacy

scholarly journals Safety and efficacy of ferric citrate in patients with nondialysis-dependent chronic kidney disease

PLoS ONE ◽  
2017 ◽  
Vol 12 (11) ◽  
pp. e0188712 ◽  
Author(s):  
Glenn M. Chertow ◽  
Geoffrey A. Block ◽  
John F. Neylan ◽  
Pablo E. Pergola ◽  
Katrin Uhlig ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Ferric Citrate ◽  
Safety And Efficacy

Ferric Citrate Dosing in Iron Deficiency Anemia in Nondialysis-Dependent Chronic Kidney Disease

2021 ◽  
pp. 1-10
Author(s):  
Pablo E. Pergola ◽  
Diogo Belo ◽  
Paul Crawford ◽  
Moustafa Moustafa ◽  
Wenli Luo ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Ferric Citrate ◽  
Deficiency Anemia ◽  
Open Label ◽  
Starting Dose ◽  
Dosing Regimens

<b><i>Introduction:</i></b> Ferric citrate (FC) is indicated as an oral iron replacement for iron deficiency anemia in adult patients with chronic kidney disease (CKD) not on dialysis. The recommended starting dose is one 1-g tablet three times daily (TID). This study investigated long-term efficacy and safety of different FC dosing regimens for treating anemia in nondialysis-dependent CKD (NDD-CKD). <b><i>Methods:</i></b> In this phase 4, randomized, open-label, multicenter study, patients with anemia with NDD-CKD (estimated glomerular filtration rate, ≥20 mL/min and &#x3c;60 mL/min) were randomized 1:1 to one FC tablet (1-g equivalent to 210 mg ferric iron) TID (3 g/day) or 2 tablets twice daily (BID; 4 g/day). At week 12, dosage was increased to 2 tablets TID (6 g/day) or 3 tablets BID (6 g/day) in patients whose hemoglobin (Hb) levels increased &#x3c;0.5 g/dL or were &#x3c;10 g/dL. Primary endpoint was mean change in Hb from baseline to week 24. <b><i>Results:</i></b> Of 484 patients screened, 206 were randomized and 205 received FC. Mean (standard deviation) changes from baseline in Hb at week 24 were 0.77 (0.84) g/dL with FC TID 3 g/day and 0.70 (0.98) g/dL with FC BID 4 g/day. <b><i>Discussion/Conclusions:</i></b> FC administered BID and TID for 48 weeks was safe and effective for treating anemia in this population, supporting potentially increased dosing flexibility.

scholarly journals Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial

2020 ◽  
Vol 36 (1) ◽  
pp. 111-120 ◽  
Author(s):  
Sunil Bhandari ◽  
Philip A Kalra ◽  
Mario Berkowitz ◽  
Diogo Belo ◽  
Lars L Thomsen ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Single Dose ◽  
Kidney Disease ◽  
Iron Deficiency ◽  
Iron Sucrose ◽  
Hypersensitivity Reactions ◽  
Open Label ◽  
Pronounced Increase ◽  
Safety And Efficacy ◽  
Significant Difference

Abstract Background The optimal intravenous (IV) iron would allow safe correction of iron deficiency at a single infusion over a short time. The FERWON-NEPHRO trial evaluated the safety and efficacy of iron isomaltoside 1000/ferric derisomaltose (IIM) in patients with non-dialysis-dependent chronic kidney disease and iron deficiency anaemia. Methods In this randomized, open-label and multi-centre trial conducted in the USA, patients were randomized 2:1 to a single dose of 1000 mg IIM or iron sucrose (IS) administered as 200 mg IV injections up to five times within a 2-week period. The co-primary endpoints were serious or severe hypersensitivity reactions and change in haemoglobin (Hb) from baseline to Week 8. Secondary endpoints included incidence of composite cardiovascular adverse events (AEs). Results A total of 1538 patients were enrolled (mean estimated glomerular filtration rate 35.5 mL/min/1.73 m2). The co-primary safety objective was met based on no significant difference in the incidence of serious or severe hypersensitivity reactions in the IIM and IS groups [0.3% versus 0%; risk difference: 0.29% (95% confidence interval: –0.19; 0.77; P &gt; 0.05)]. Incidence of composite cardiovascular AEs was significantly lower in the IIM versus IS group (4.1% versus 6.9%; P = 0.025). Compared with IS, IIM led to a more pronounced increase in Hb during the first 4 weeks (P ≤ 0.021), and change in Hb to Week 8 showed non-inferiority, confirming that the co-primary efficacy objective was met. Conclusions Compared with multiple doses of IS, a single dose of IIM induced a non-inferior 8-week haematological response, comparably low rates of hypersensitivity reactions, and a significantly lower incidence of composite cardiovascular AEs.

Zinc levels after iron supplementation in patients with chronic kidney disease

2004 ◽  
Vol 14 (3) ◽  
pp. 164-169 ◽  
Author(s):  
Denise Mafra ◽  
Lilian Cuppari ◽  
Déborah I.T Fávaro ◽  
Sı́lvia M.F Cozzolino
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Iron Supplementation ◽  
Zinc Levels

MO547ASSOCIATION BETWEEN SERUM INDICES OF IRON METABOLISM AND CARDIOVASCULAR MORBIDITY IN PATIENTS WITH PREDIALYSIS CHRONIC KIDNEY DISEASE

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Takeshi Hasegawa ◽  
Takahiro Imaizumi ◽  
Kenta Murotani ◽  
Takayuki Hamano ◽  
Masafumi Fukagawa
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Iron Metabolism ◽  
Iron Supplementation ◽  
Transferrin Saturation ◽  
Cox Proportional Hazards ◽  
Function Evaluation ◽  
Iron Deficient ◽  
Increased Risk ◽  
Reduced Risk

Abstract Background and Aims Patients with predialysis chronic kidney disease (CKD) have a greater risk of developing cardiovascular disease (CVD) events than the general population. Anaemia is the most frequent comorbidity in pre-dialysis CKD patients and is associated with an increase in CVD events. Iron deficiency is the most frequent cause of erythropoiesis-stimulating agents (ESAs) resistant anaemia in CKD patients and is modifiable by therapeutic intervention. However, the optimal ranges of iron markers are uncertain in predialysis CKD patients. Therefore, we aimed to investigate the association between serum indices of iron metabolism and the incidence of CVD events in patients with predialysis CKD using the CKD-Japan Cohort (CKD-JAC) data. Method We prospectively followed 1550 CKD patients aged 20-75 years with an estimated glomerular filtration rate (eGFR) &lt;60 mL/min/1.73 m2 for a mean of 4.21 years. We set serum transferrin saturation (TSAT) and ferritin levels as the main exposures to be tested. Our main outcome measures were any of the CVD events including fatal or non-fatal myocardial infarction, congestive heart failure (CHF), angina pectoris, arrhythmia, aorta dissection, cerebrovascular disorder, and peripheral artery diseases identified at each facility and adjudicated by the independent cardiac function evaluation committee. Multivariable Cox proportional hazards regression models were employed to examine the association between serum TSAT or ferritin levels with time to events. Death was considered as a competing risk with the Fine and Gray model. All models were stratified by facilities and adjusted for potential confounders as follows: age, sex, systolic blood pressure, diabetes mellitus, history of CHF, haemoglobin, serum calcium, serum phosphorus, intact parathyroid hormone, eGFR, proteinuria, ESAs, iron supplementation, renin-angiotensin system inhibitors, and beta-blockers. We also applied the multivariable fractional polynomial interaction (MFPI) approach to investigate whether TSAT levels are the effect modifier of the association between iron supplementation and the outcomes. Results In the overall cohort, 208 (13.4 %) patients developed CVD events (including 97 CHF) during the follow-up period (26.6 events/1000 person-year). The incidence rate of CVD events was the highest in the TSAT &lt; 20% category (33.0 events/1000 person-year). Compared to patients in the TSAT &gt; 40% category, those in the TSAT &lt; 20% category demonstrated an increased risk of CVD events (adjusted hazard ratio (AHR): 1.86, 95% confidence interval (CI): 1.06-3.26) and CHF events (AHR: 2.82, 95% CI: 1.15-6.89), respectively. Meanwhile, there was no association between serum ferritin levels and the risk of developing CVD or CHF events. MFPI analyses showed a reduced risk of CVD in patients receiving iron supplementation only in patients with TSAT &lt;20% (P for interaction=0.02). Conclusion Maintaining TSAT &gt;20% could be effective to reduce the risk of developing CVD events (especially CHF) in patients with predialysis CKD. Our analyses also suggest that iron-deficient patients with predialysis CKD may benefit from iron supplementation for reduced risk of CVD events.

A Comparative Review of Erythropoiesis Stimulating Agents

2008 ◽  
Vol 21 (6) ◽  
pp. 424-430
Author(s):  
Nicole L. Metzger ◽  
Kerry E. Francis ◽  
Stacy A. Voils
Keyword(s):  
Chronic Kidney Disease ◽  
Clinical Trials ◽  
Kidney Disease ◽  
Tumor Progression ◽  
Safety And Efficacy ◽  
Regulatory Issues ◽  
Erythropoiesis Stimulating Agents ◽  
Disease States ◽  
Comparative Review ◽  
The Us

Erythropoiesis stimulating agents have been used for more than a decade in patients with chronic kidney disease, malignancy, and other disease states where anemia is common. Recently, several clinical trials have questioned the safety and efficacy of these agents. Thrombosis and increase in tumor progression as well as a potential increase in mortality have been noted in some trials and have generated growing concern regarding whether these agents should remain on the US market. Subsequently, reimbursement from some payers for erythropoiesis stimulating agent administration has become somewhat restrictive. We address the pharmacology, pharmacokinetics, pharmacodynamics, safety, efficacy, and pharmacoeconomics of erythropoiesis stimulating agents as well as emerging regulatory issues pertaining to the administration of erythropoiesis stimulating agents.

Long-term safety and efficacy of veverimer in patients with metabolic acidosis in chronic kidney disease: a multicentre, randomised, blinded, placebo-controlled, 40-week extension

The Lancet ◽  
2019 ◽  
Vol 394 (10196) ◽  
pp. 396-406 ◽  
Author(s):  
Donald E Wesson ◽  
Vandana Mathur ◽  
Navdeep Tangri ◽  
Yuri Stasiv ◽  
Dawn Parsell ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Metabolic Acidosis ◽  
Kidney Disease ◽  
Safety And Efficacy
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