Optimal Phosphate Control Related to Coronary Artery Calcification in Dialysis Patients.

Yoshitaka Isaka, Takayuki Hamano, Hideki Fujii, Yoshihiro Tsujimoto, Fumihiko Koiwa, Yusuke Sakaguchi, Ryoichi Tanaka, Noriyuki Tomiyama, Fuminari Tatsugami, Satoshi Teramukai

Journal: Journal of the American Society of Nephrology : JASN 2021;32(3):723-735

PMID: 33547218

Abstract

BACKGROUND

In patients on maintenance dialysis, cardiovascular mortality risk is remarkably high, which can be partly explained by severe coronary artery calcification (CAC). Hyperphosphatemia has been reported to be associated with the severity of CAC. However, the optimal phosphate range in patients on dialysis remains unknown. This study was planned to compare the effects on CAC progression of two types of noncalcium-based phosphate binders and of two different phosphate target ranges.

METHODS

We conducted a randomized, open-label, multicenter, interventional trial with a two by two factorial design. A total of 160 adults on dialysis were enrolled and randomized to the sucroferric oxyhydroxide or lanthanum carbonate group, with the aim of reducing serum phosphate to two target levels (3.5-4.5 mg/dl in the strict group and 5.0-6.0 mg/dl in the standard group). The primary end point was percentage change in CAC scores during the 12-month treatment.

RESULTS

The full analysis set included 115 patients. We observed no significant difference in percentage change in CAC scores between the lanthanum carbonate group and the sucroferric oxyhydroxide group. On the other hand, percentage change in CAC scores in the strict group (median of 8.52; interquartile range, -1.0-23.9) was significantly lower than that in the standard group (median of 21.8; interquartile range, 10.0-36.1; =0.006). This effect was pronounced in older (aged 65-74 years) versus younger (aged 20-64 years) participants ( value for interaction =0.003). We observed a similar finding for the absolute change in CAC scores.

CONCLUSIONS

Further study with a larger sample size is needed, but strict phosphate control shows promise for delaying progression of CAC in patients undergoing maintenance hemodialysis.

CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER

Evaluate the New Phosphate Iron-Based Binder Sucroferric Oxyhydroxide in Dialysis Patients with the Goal of Advancing the Practice of EBM (EPISODE), jRCTs051180048.

Copyright © 2021 by the American Society of Nephrology.

Address: Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Japan.; Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Japan.; Department of Nephrology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.; Division of Nephrology and Kidney Center, Kobe University Graduate School of Medicine.; Division of Internal Medicine, Medical Corporation Aijinkai Inoue Hospital, Suita, Japan.; Division of Nephrology, Department of Internal Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan.; Department of Radiology, Iwate Medical University School of Medicine, Shiwa, Japan.; Division of Dental Radiology, Department of Reconstructive Oral and Maxillofacial Surgery, Iwate Medical University School of Dentistry, Shiwa, Japan.; Department of Radiology, Osaka University Graduate School of Medicine, Suita, Japan.; Department of Diagnostic Radiology, Hiroshima University, Hiroshima, Japan.; Department of Biostatistics, Kyoto Prefectural University of Medicine, Kyoto, Japan.
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