Efficacy and Tolerability of Sevelamer Carbonate in Hyperphosphatemic Patients Who Have Chronic Kidney Disease and Are Not on Dialysis

Nephrologische Klinik, Klinikum Coburg gGmbH, Ketschendorfer Strasse 33, 96450 Coburg, Germany.
Clinical Journal of the American Society of Nephrology (Impact Factor: 4.61). 07/2008; 3(4):1125-30. DOI: 10.2215/CJN.05161107
Source: PubMed


Sevelamer carbonate is an improved, buffered form of sevelamer hydrochloride developed for the treatment of hyperphosphatemia in patients with chronic kidney disease. This study investigated the ability of sevelamer carbonate to control serum phosphorous in hyperphosphatemic patients who had chronic kidney disease and were not on dialysis.
This was an open-label, dosage-titration study. Patients with serum phosphorus > or =5.5 mg/dl were enrolled (n = 46). Sevelamer carbonate was administered for 8 wk. Patients were supplemented with native vitamin D (400 IU). The primary efficacy parameter was the change from baseline in serum phosphorous. Secondary measures included the percentage of serum phosphorus responders; changes in serum lipids, calcium-phosphorus product, and bicarbonate; and safety and tolerability.
Sevelamer carbonate treatment resulted in a statistically significant decrease in mean serum phosphorous levels from baseline to end of treatment. A total of 75% of patients with stage 4 and 70% of patients with stage 5 chronic kidney disease achieved the target serum phosphorous at the end of treatment. There were statistically significant decreases in serum calcium-phosphorus product and total and low-density lipoprotein cholesterol at the end of treatment and a statistically significant increase in mean serum bicarbonate levels (from 16.6 to 18.2 mEq/L). Sevelamer carbonate was well tolerated.
Sevelamer carbonate is an effective and well-tolerated therapy for the control of phosphorous levels in hyperphosphatemic patients who have chronic kidney disease and are not on dialysis.

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Available from: Stanley Fan, Apr 15, 2015
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    • "Similarly, in non-dialysis-dependent CKD, phosphorus binders have demonstrated a survival benefit in men with moderate and advanced disease (Figure 3).28 Some studies suggest that sevelamer may improve surrogate markers of CKD progression (eg, serum phosphorus, bicarbonate) and CV risk (eg, calcification) in predialysis patients;52,53 however, larger and more rigorous studies are warranted to confirm these findings. Phosphorus binders also allow greater dietary variety and liberalized protein intake, which may address both protein needs and food fatigue. "
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    ABSTRACT: This review explores the challenges and solutions in educating patients with chronic kidney disease (CKD) to lower serum phosphorus while avoiding protein insufficiency and hypercalcemia. A literature search including terms "hyperphosphatemia," "patient education," "food fatigue," "hypercalcemia," and "phosphorus-protein ratio" was undertaken using PubMed. Hyperphosphatemia is a strong predictor of mortality in advanced CKD and is remediated via diet, phosphorus binders, and dialysis. Dietary counseling should encourage the consumption of foods with the least amount of inorganic or absorbable phosphorus, low phosphorus-to-protein ratios, and adequate protein content, and discourage excessive calcium intake in high-risk patients. Emerging educational initiatives include food labeling using a "traffic light" scheme, motivational interviewing techniques, and the Phosphate Education Program - whereby patients no longer have to memorize the phosphorus content of each individual food component, but only a "phosphorus unit" value for a limited number of food groups. Phosphorus binders are associated with a clear survival advantage in CKD patients, overcome the limitations associated with dietary phosphorus restriction, and permit a more flexible approach to achieving normalization of phosphorus levels. Patient education on phosphorus and calcium management can improve concordance and adherence and empower patients to collaborate actively for optimal control of mineral metabolism.
    Patient Preference and Adherence 05/2013; 7:379-90. DOI:10.2147/PPA.S43486 · 1.68 Impact Factor
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    • "Such studies are furthers hampered by the fact that phosphate-lowering effects are not clearly visible, because a decline in phosphaturia may blunt the changes in circulating phosphate levels. The efficacy of sevelamer carbonate in predialysis CKD patients was recently examined in 19 nephrology centers across Northern Europe and Australia in a single-arm study approach with a poststudy washout period [27]. "
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    ABSTRACT: When compared to the available information for patients on dialysis (CKD stage 5D), data on the epidemiology and appropriate treatment of calcium and phosphate metabolism in the predialysis stages of chronic kidney disease (CKD) are quite limited. Perceptible derangements of calcium and phosphate levels start to become apparent when GFR falls below 30 mL/min in some, but not all, patients. However, hyperphosphatemia may be a significant morbidity and mortality risk predictor in predialysis CKD stages. The RIND study, evaluating progression of coronary artery calcification in incident hemodialysis patients, indirectly demonstrated that vascular calcification processes start to manifest in CKD patients prior to the dialysis stage, which may be closely linked to early and invisible derangements in calcium and phosphate homeostasis. Novel insights into the pathophysiology of calcium and phosphate handling such as the discovery of FGF23 and other phosphatonins suggest that a more complex assessment of phosphate balance is warranted, possibly including measurements of fractional phosphate excretion and phosphatonin levels in order to appropriately evaluate disordered metabolism in earlier stages of kidney disease. As a consequence, early and preventive treatment approaches may have to be developed for patients in CKD stages 3-5 to halt progression of CKD-MBD.
    05/2011; 2011:970245. DOI:10.4061/2011/970245
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    • "Urinary excretion of phosphorus was not measured in this trial. Previous studies have shown that administration of phosphate binders resulted in a significant decrease in urinary phosphorus excretion in CKD patients [30,31]. Finally, the present study did not examine patients' outcomes as this usually requires a much larger sample size. "
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    ABSTRACT: Hyperphosphatemia in patients with chronic kidney disease (CKD) contributes to secondary hyperparathyroidism, soft tissue calcification, and increased mortality risk. This trial was conducted to examine the efficacy and safety of calcium acetate in controlling serum phosphorus in pre-dialysis patients with CKD. In this randomized, double-blind, placebo-controlled trial, 110 nondialyzed patients from 34 sites with estimated GFR < 30 mL/min/1.73 m² and serum phosphorus > 4.5 mg/dL were randomized to calcium acetate or placebo for 12 weeks. The dose of study drugs was titrated to achieve target serum phosphorus of 2.7-4.5 mg/dL. Serum phosphorus, calcium, iPTH, bicarbonate and serum albumin were measured at baseline and every 2 weeks for the 12 week study period. The primary efficacy endpoint was serum phosphorus at 12 weeks. Secondary endpoints were to measure serum calcium and intact parathyroid hormone (iPTH) levels. At 12 weeks, serum phosphorus concentration was significantly lower in the calcium acetate group compared to the placebo group (4.4 ± 1.2 mg/dL vs. 5.1 ± 1.4 mg/dL; p = 0.04). The albumin-adjusted serum calcium concentration was significantly higher (9.5 ± 0.8 vs. 8.8 ± 0.8; p < 0.001) and iPTH was significantly lower in the calcium acetate group compared to placebo (150 ± 157 vs. 351 ± 292 pg/mL respectively; p < 0.001). At 12 weeks, the proportions of subjects who had hypocalcemia were 5.4% and 19.5% for the calcium acetate and the placebo groups, respectively, while the proportions of those with hypercalcemia were 13.5% and 0%, respectively. Adverse events did not differ between the treatment groups. In CKD patients not yet on dialysis, calcium acetate was effective in reducing serum phosphorus and iPTH over a 12 week period. NCT00211978.
    BMC Nephrology 02/2011; 12(1):9. DOI:10.1186/1471-2369-12-9 · 1.69 Impact Factor
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