A randomized trial of sevelamer hydrochloride (RenaGel) with and without supplemental calcium. Strategies for the control of hyperphosphatemia and hyperparathyroidism in hemodialysis patients.

摘要: Objective We have previously shown sevelamer hydrochloride (RenaGel) to be an effective and well-tolerated treatment for hyperphosphatemia in hemodialysis patients. Patients methods performed a randomized clinical trial compare the efficacy of RenaGel alone with calcium, using serum phosphorus concentration intact parathyroid hormone (PTH) as principal outcomes interest. Calcium (900 mg elemental) was provided once-nightly dose on empty stomach. 71 patients were included intent-to-treat population; 55 completed 16-week study period (2 weeks washout, 12 treatment, 2 washout). 49% subjects taking vitamin D metabolites. Results Serum PTH rose significantly when stopped their phosphate binders during both washout periods. calcium equally at reducing (mean change -2.4 mg/dL vs. -2.3 mg/dL). associated small increase 0.3 0.0 group, P = 0.09) that not statistically significant. During phase, reduction tended greater group (median -67.0 -22.5 pg/mL 0.07). Non-users metabolites treated experienced significant decrease -114.5 -22 0.006). Adverse events seen equal frequency groups, being generally mild intensity, rarely attributable drugs. Conclusion conclude are similarly ESRD-related hyperphosphatemia. Provision supplemental or may enhance control hyperparathyroidism.