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Evaluation of calcium acetate/magnesium carbonate as a phosphate binder compared with sevelamer hydrochloride in haemodialysis patients: a controlled randomized study (CALMAG study) assessing efficacy and tolerability.

de Francisco AL, Leidig M, Covic AC, Ketteler M, Benedyk-Lorens E, Mircescu GM, Scholz C, Ponce P, Passlick-Deetjen J - Nephrol. Dial. Transplant. (2010)

Bottom Line: Serum phosphorus levels had decreased significantly with both drugs at week 25, and the study hypothesis of CaMg not being inferior to sevelamer-HCl was confirmed.Ionized serum calcium did not differ between groups; total serum calcium increased in the CaMg group (treatment difference 0.0477 mmol/L; P = 0.0032) but was not associated with a higher risk of hypercalcaemia.It had a good tolerability profile and thus may represent an effective treatment of hyperphosphataemia.

View Article: PubMed Central - PubMed

Affiliation: Hospital Marques de Valdecilla, Universidad de Cantabria, Santander, Spain. angelmartindefrancisco@gmail.com

ABSTRACT

Background: Phosphate binders are required to control serum phosphorus in dialysis patients. A phosphate binder combining calcium and magnesium offers an interesting therapeutic option.

Methods: This controlled randomized, investigator-masked, multicentre trial investigated the effect of calcium acetate/magnesium carbonate (CaMg) on serum phosphorus levels compared with sevelamer hydrochloride (HCl). The study aim was to show non-inferiority of CaMg in lowering serum phosphorus levels into Kidney Disease Outcome Quality Initiative (K/DOQI) target level range after 24 weeks. Three hundred and twenty-six patients from five European countries were included. After a phosphate binder washout period, 255 patients were randomized in a 1:1 fashion. Two hundred and four patients completed the study per protocol (CaMg, N = 105; dropouts N = 18; sevelamer-HCl, N = 99; dropouts N = 34). Patient baseline characteristics were similar in both groups.

Results: Serum phosphorus levels had decreased significantly with both drugs at week 25, and the study hypothesis of CaMg not being inferior to sevelamer-HCl was confirmed. The area under the curve for serum phosphorus (P = 0.0042) and the number of visits above K/DOQI (≤1.78 mmol/L, P = 0.0198) and Kidney disease: Improving global outcomes (KDIGO) targets (≤1.45 mmol/L, P = 0.0067) were significantly lower with CaMg. Ionized serum calcium did not differ between groups; total serum calcium increased in the CaMg group (treatment difference 0.0477 mmol/L; P = 0.0032) but was not associated with a higher risk of hypercalcaemia. An asymptomatic increase in serum magnesium occurred in CaMg-treated patients (treatment difference 0.2597 mmol/L, P < 0.0001). There was no difference in the number of patients with adverse events.

Conclusion: CaMg was non-inferior to the comparator at controlling serum phosphorus levels at Week 25. There was no change in ionized calcium; there was minimal increase in total serum calcium and a small increase in serum magnesium. It had a good tolerability profile and thus may represent an effective treatment of hyperphosphataemia.

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Time course of iPTH of the CaMg group (n = 118) and of the sevelamer-HCl group (n = 112) (FAS), P = 0.0085 (ANCOVA); within-group changes CaMg: *Week 9 vs baseline: P < 0.0001, **Week 25 vs Week 9: P = 0.0768; within-group changes sevelamer-HCL: * Week 9 vs baseline: P = 0.0090, ** Week 25 vs Week 9: P = 0.0242.
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fig5: Time course of iPTH of the CaMg group (n = 118) and of the sevelamer-HCl group (n = 112) (FAS), P = 0.0085 (ANCOVA); within-group changes CaMg: *Week 9 vs baseline: P < 0.0001, **Week 25 vs Week 9: P = 0.0768; within-group changes sevelamer-HCL: * Week 9 vs baseline: P = 0.0090, ** Week 25 vs Week 9: P = 0.0242.

Mentions: iPTH decreased during the course of the study in both groups until Week 9 and then increased significantly in the sevelamer-HCl group but without any further significant change in the CaMg group (Table 4, Figure 5). At Week 25, the treatment difference was −64.4773 pg/mL which was statistically significant (P = 0.0085). The AUC of iPTH was also significantly lower in the CaMg group (data not shown). Alkaline phosphatase (AP) increased significantly in both groups until Week 9 (P < 0.0001 for both groups). Thereafter, AP increased like iPTH in the sevelamer-HCl group but not in the CaMg group. At Week 25, the treatment difference was statistically significantly different (P < 0.0001) with the respective mean difference of −24.0067 U/L (Table 4).


Evaluation of calcium acetate/magnesium carbonate as a phosphate binder compared with sevelamer hydrochloride in haemodialysis patients: a controlled randomized study (CALMAG study) assessing efficacy and tolerability.

de Francisco AL, Leidig M, Covic AC, Ketteler M, Benedyk-Lorens E, Mircescu GM, Scholz C, Ponce P, Passlick-Deetjen J - Nephrol. Dial. Transplant. (2010)

Time course of iPTH of the CaMg group (n = 118) and of the sevelamer-HCl group (n = 112) (FAS), P = 0.0085 (ANCOVA); within-group changes CaMg: *Week 9 vs baseline: P < 0.0001, **Week 25 vs Week 9: P = 0.0768; within-group changes sevelamer-HCL: * Week 9 vs baseline: P = 0.0090, ** Week 25 vs Week 9: P = 0.0242.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2957591&req=5

fig5: Time course of iPTH of the CaMg group (n = 118) and of the sevelamer-HCl group (n = 112) (FAS), P = 0.0085 (ANCOVA); within-group changes CaMg: *Week 9 vs baseline: P < 0.0001, **Week 25 vs Week 9: P = 0.0768; within-group changes sevelamer-HCL: * Week 9 vs baseline: P = 0.0090, ** Week 25 vs Week 9: P = 0.0242.
Mentions: iPTH decreased during the course of the study in both groups until Week 9 and then increased significantly in the sevelamer-HCl group but without any further significant change in the CaMg group (Table 4, Figure 5). At Week 25, the treatment difference was −64.4773 pg/mL which was statistically significant (P = 0.0085). The AUC of iPTH was also significantly lower in the CaMg group (data not shown). Alkaline phosphatase (AP) increased significantly in both groups until Week 9 (P < 0.0001 for both groups). Thereafter, AP increased like iPTH in the sevelamer-HCl group but not in the CaMg group. At Week 25, the treatment difference was statistically significantly different (P < 0.0001) with the respective mean difference of −24.0067 U/L (Table 4).

Bottom Line: Serum phosphorus levels had decreased significantly with both drugs at week 25, and the study hypothesis of CaMg not being inferior to sevelamer-HCl was confirmed.Ionized serum calcium did not differ between groups; total serum calcium increased in the CaMg group (treatment difference 0.0477 mmol/L; P = 0.0032) but was not associated with a higher risk of hypercalcaemia.It had a good tolerability profile and thus may represent an effective treatment of hyperphosphataemia.

View Article: PubMed Central - PubMed

Affiliation: Hospital Marques de Valdecilla, Universidad de Cantabria, Santander, Spain. angelmartindefrancisco@gmail.com

ABSTRACT

Background: Phosphate binders are required to control serum phosphorus in dialysis patients. A phosphate binder combining calcium and magnesium offers an interesting therapeutic option.

Methods: This controlled randomized, investigator-masked, multicentre trial investigated the effect of calcium acetate/magnesium carbonate (CaMg) on serum phosphorus levels compared with sevelamer hydrochloride (HCl). The study aim was to show non-inferiority of CaMg in lowering serum phosphorus levels into Kidney Disease Outcome Quality Initiative (K/DOQI) target level range after 24 weeks. Three hundred and twenty-six patients from five European countries were included. After a phosphate binder washout period, 255 patients were randomized in a 1:1 fashion. Two hundred and four patients completed the study per protocol (CaMg, N = 105; dropouts N = 18; sevelamer-HCl, N = 99; dropouts N = 34). Patient baseline characteristics were similar in both groups.

Results: Serum phosphorus levels had decreased significantly with both drugs at week 25, and the study hypothesis of CaMg not being inferior to sevelamer-HCl was confirmed. The area under the curve for serum phosphorus (P = 0.0042) and the number of visits above K/DOQI (≤1.78 mmol/L, P = 0.0198) and Kidney disease: Improving global outcomes (KDIGO) targets (≤1.45 mmol/L, P = 0.0067) were significantly lower with CaMg. Ionized serum calcium did not differ between groups; total serum calcium increased in the CaMg group (treatment difference 0.0477 mmol/L; P = 0.0032) but was not associated with a higher risk of hypercalcaemia. An asymptomatic increase in serum magnesium occurred in CaMg-treated patients (treatment difference 0.2597 mmol/L, P < 0.0001). There was no difference in the number of patients with adverse events.

Conclusion: CaMg was non-inferior to the comparator at controlling serum phosphorus levels at Week 25. There was no change in ionized calcium; there was minimal increase in total serum calcium and a small increase in serum magnesium. It had a good tolerability profile and thus may represent an effective treatment of hyperphosphataemia.

Show MeSH
Related in: MedlinePlus