Background: 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.
Methods: 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.
Results: 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.
Conclusions: In CKD patients not yet on dialysis, calcium acetate was effective in reducing serum phosphorus and iPTH over a 12 week period.
Trial Registration: www.clinicaltrials.gov NCT00211978.
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http://dx.doi.org/10.1186/1471-2369-12-9 | DOI Listing |
Front Med (Lausanne)
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Department of Orthopedics, The Second People's Hospital of Hefei, Hefei Hospital Affiliated to Anhui Medical University, Hefei, Anhui, China.
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Dr Md Arif Rabbany, Junior Consultant, Department of Neonatology, Mymensingh Medical College Hospital (MMCH), Mymensingh, Bangladesh; E-mail:
Sepsis is a leading cause of neonatal morbidity and mortality worldwide, especially in low- and middle- income countries (LMIC). It is estimated to cause almost 1 million deaths that accounts for more than 25.0% of neonatal deaths worldwide.
View Article and Find Full Text PDFInt Urol Nephrol
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Department of Nephrology, The Third Affiliated Hospital of Soochow University, Changzhou, China.
Secondary hyperparathyroidism (SHPT) is one of the most common complications of chronic kidney disease (CKD). Vitamin D levels begin to decrease in the early stages of CKD, and these vitamin D-related changes play a central role in the occurrence and development of SHPT. Vitamin D-based drugs, which inhibit parathyroid hormone secretion either directly or indirectly, are commonly used to treat SHPT.
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Dayanand Medical College and Hospital, Tagore Nagar, civil lines, Ludhiana, Punjab 141001 India.
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Department of Pediatrics, "Victor Babes" University of Medicine and Pharmacy, 300041 Timisoara, Romania.
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