Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2013 Feb;8(2):280-9.
doi: 10.2215/CJN.08230811. Epub 2012 Nov 2.

Randomized clinical trial of the iron-based phosphate binder PA21 in hemodialysis patients

Rudolf P Wüthrich  1 , Michel Chonchol, Adrian Covic, Sylvain Gaillard, Edward Chong, James A Tumlin
Affiliations
Clinical Trial

Randomized clinical trial of the iron-based phosphate binder PA21 in hemodialysis patients

Rudolf P Wüthrich et al. Clin J Am Soc Nephrol. 2013 Feb.

Abstract

Background and objectives: A dose-finding study was undertaken to investigate the efficacy of PA21, a novel polynuclear iron(III)-oxyhydroxide phosphate binder.

Design, setting, participants, & measurements: In a randomized, active-controlled, multicenter, open-label study at 50 clinical sites in Europe and the United States, hemodialysis patients were randomized to PA21 at dosages of 1.25, 5.0, 7.5, 10.0, or 12.5 g/d or sevelamer-HCl 4.8 g/d for 6 weeks. The primary efficacy endpoint was the change in serum phosphorus concentration from baseline.

Results: There were 154 participants who were randomized and received the study drug. All groups except PA21 1.25 g/d showed a significant decrease in serum phosphorus. Mean decreases in serum phosphorus in PA21 10 g/d and 12.5 g/d were -2.00±1.71 mg/dl and -1.69±1.81 mg/dl, respectively. A similar decrease to sevelamer-HCl (-1.06±1.35 mg/dl) was seen with PA21 5.0 g/d (-1.08±2.12 mg/dl) and 7.5 g/d (-1.25±1.21 mg/d). Overall, 60.9% of participants randomized to PA21 and 57.7% randomized to sevelamer-HCl reported ≥1 adverse event. The most frequent adverse events were hypophosphatemia (18.0%) and discolored feces (11.7%) for the pooled PA21 dose groups, and diarrhea, hypophosphatemia, and hypotension (each 11.5%) for sevelamer-HCl. Discontinuation due to adverse events occurred at a similar rate in PA21-treated (21.1%) and sevelamer-HCl-treated (23.1%) participants.

Conclusions: PA21 5-12.5 g/d significantly reduces serum phosphorus in hemodialysis patients. The 5 g/d and 7.5 g/d dosages showed similar efficacy to 4.8 g/d of sevelamer-HCl. The adverse events rate was similar for PA21 and sevelamer-HCl.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Patient disposition.
Figure 2.
Figure 2.
Change in serum phosphorus from baseline (week 1) according to treatment group. Data are shown as mean (SEM) change from baseline to end of treatment (primary endpoint) according to treatment group (efficacy and per protocol populations) (last observation carried forward, LOCF). *P=0.02, **P=0.003, ***P<0.001 (all versus baseline).
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Coladonato JA: Control of hyperphosphatemia among patients with ESRD. J Am Soc Nephrol 16[Suppl 2]: S107–S114, 2005 - PubMed
    1. Bleyer AJ, Burke SK, Dillon M, Garrett B, Kant KS, Lynch D, Rahman SN, Schoenfeld P, Teitelbaum I, Zeig S, Slatopolsky E: A comparison of the calcium-free phosphate binder sevelamer hydrochloride with calcium acetate in the treatment of hyperphosphatemia in hemodialysis patients. Am J Kidney Dis 33: 694–701, 1999 - PubMed
    1. Block GA, Spiegel DM, Ehrlich J, Mehta R, Lindbergh J, Dreisbach A, Raggi P: Effects of sevelamer and calcium on coronary artery calcification in patients new to hemodialysis. Kidney Int 68: 1815–1824, 2005 - PubMed
    1. Chertow GM, Burke SK, Raggi P, Treat to Goal Working Group : Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int 62: 245–252, 2002 - PubMed
    1. Kidney Disease Improving Global Outcomes (KDIGO): Clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD). Chapter 3.1: Diagnosis of CKD-MBD: Biochemical abnormalities. Kidney Int Supp 76[Suppl 113]: S22–S49, 2009 - PubMed

Publication types