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A phase III study of the efficacy and safety of a novel iron-based phosphate binder in dialysis patients.
Kidney Int. 2014 Sep; 86(3):638-47.KI

Abstract

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 1.0-3.0 g per day and 348 received sevelamer 4.8-14.4 g 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 -0.71 mmol/l (PA21) and -0.79 mmol/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 (250 mg 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.

Authors+Show Affiliations

Division of Nephrology, RWTH University Hospital Aachen, Aachen, Germany.8216;Grigore T Popa' University of Medicine and Pharmacy, Iasi, Romania.Coburg Clinic and KfH-Dialysis Center, Coburg, Germany.University of California, Los Angeles, California, USA.Vifor Pharma, Glattbrugg, Switzerland.Vifor Pharma, Glattbrugg, Switzerland.Vifor Pharma, Glattbrugg, Switzerland.NorthShore University Health System University of Chicago Pritzker School of Medicine, Evanston, Illinois, USA.No affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

24646861

Citation

Floege, Jürgen, et al. "A Phase III Study of the Efficacy and Safety of a Novel Iron-based Phosphate Binder in Dialysis Patients." Kidney International, vol. 86, no. 3, 2014, pp. 638-47.
Floege J, Covic AC, Ketteler M, et al. A phase III study of the efficacy and safety of a novel iron-based phosphate binder in dialysis patients. Kidney Int. 2014;86(3):638-47.
Floege, J., Covic, A. C., Ketteler, M., Rastogi, A., Chong, E. M., Gaillard, S., Lisk, L. J., & Sprague, S. M. (2014). A phase III study of the efficacy and safety of a novel iron-based phosphate binder in dialysis patients. Kidney International, 86(3), 638-47. https://doi.org/10.1038/ki.2014.58
Floege J, et al. A Phase III Study of the Efficacy and Safety of a Novel Iron-based Phosphate Binder in Dialysis Patients. Kidney Int. 2014;86(3):638-47. PubMed PMID: 24646861.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A phase III study of the efficacy and safety of a novel iron-based phosphate binder in dialysis patients. AU - Floege,Jürgen, AU - Covic,Adrian C, AU - Ketteler,Markus, AU - Rastogi,Anjay, AU - Chong,Edward M F, AU - Gaillard,Sylvain, AU - Lisk,Laura J, AU - Sprague,Stuart M, AU - ,, Y1 - 2014/03/19/ PY - 2013/06/12/received PY - 2013/12/23/revised PY - 2014/01/02/accepted PY - 2014/3/21/entrez PY - 2014/3/22/pubmed PY - 2015/6/2/medline SP - 638 EP - 47 JF - Kidney international JO - Kidney Int VL - 86 IS - 3 N2 - 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 1.0-3.0 g per day and 348 received sevelamer 4.8-14.4 g 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 -0.71 mmol/l (PA21) and -0.79 mmol/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 (250 mg 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. SN - 1523-1755 UR - https://www.unboundmedicine.com/medline/citation/24646861/A_phase_III_study_of_the_efficacy_and_safety_of_a_novel_iron_based_phosphate_binder_in_dialysis_patients_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0085-2538(15)30319-7 DB - PRIME DP - Unbound Medicine ER -