Asset Details
Do you wish to reserve the book?
A phase III study of the efficacy and safety of a novel iron-based phosphate binder in dialysis patients
Hey, we have placed the reservation for you!
By the way, why not check out events that you can attend while you pick your title.
Oops! Something went wrong.
Looks like we were not able to place the reservation. Kindly try again later.
Are you sure you want to remove the book from the shelf?
A phase III study of the efficacy and safety of a novel iron-based phosphate binder in dialysis patients
Do you wish to request the book?
A phase III study of the efficacy and safety of a novel iron-based phosphate binder in dialysis patients
Please be aware that the book you have requested cannot be checked out. If you would like to checkout this book, you can reserve another copy
We have requested the book for you!
Your request is successful and it will be processed during the Library working hours. Please check the status of your request in My Requests.
Oops! Something went wrong.
Looks like we were not able to place your request. Kindly try again later.
Journal Article
A phase III study of the efficacy and safety of a novel iron-based phosphate binder in dialysis patients
2014
Overview
Efficacy of PA21 (sucroferric oxyhydroxide), a novel calcium-free polynuclear iron(III)-oxyhydroxide phosphate binder, was compared with that of sevelamer carbonate in an open-label, randomized, active-controlled phase III study. Seven hundred and seven hemo- and peritoneal dialysis patients with hyperphosphatemia received PA21 1.0–3.0g per day and 348 received sevelamer 4.8–14.4g per day for an 8-week dose titration, followed by 4 weeks without dose change, and then 12 weeks maintenance. Serum phosphorus reductions at week 12 were -0.71mmol/l (PA21) and -0.79mmol/l (sevelamer), demonstrating non-inferiority of, on average, three tablets of PA21 vs. eight of sevelamer. Efficacy was maintained to week 24. Non-adherence was 15.1% (PA21) vs. 21.3% (sevelamer). The percentage of patients that reported at least one treatment-emergent adverse event was 83.2% with PA21 and 76.1% with sevelamer. A higher proportion of patients withdrew owing to treatment-emergent adverse events with PA21 (15.7%) vs. sevelamer (6.6%). Mild, transient diarrhea, discolored feces, and hyperphosphatemia were more frequent with PA21; nausea and constipation were more frequent with sevelamer. After 24 weeks, 99 hemodialysis patients on PA21 were re-randomized into a 3-week superiority analysis of PA21 maintenance dose in 50 patients vs. low dose (250mg per day (ineffective control)) in 49 patients. The PA21 maintenance dose was superior to the low dose in maintaining serum phosphorus control. Thus, PA21 was effective in lowering serum phosphorus in dialysis patients, with similar efficacy to sevelamer carbonate, a lower pill burden, and better adherence.
Publisher
Elsevier Inc,Elsevier Limited,Nature Publishing Group
Subject
/ Adult
/ Aged
/ Chelating Agents - adverse effects
/ Chelating Agents - therapeutic use
/ Constipation - chemically induced
/ dialysis
/ Diarrhea - chemically induced
/ Female
/ Ferric Compounds - adverse effects
/ Ferric Compounds - therapeutic use
/ Humans
/ Hyperphosphatemia - drug therapy
/ Hyperphosphatemia - etiology
/ Male
/ PA21
/ Polyamines - adverse effects
/ Polyamines - therapeutic use
/ Renal Insufficiency, Chronic - complications
