NEWS HIGHLIGHTSMedia Articles Related to Phoslo (Calcium Acetate)
Fresenius Medical Care Announces Presentation Of First Results From The CALMAG Study For Phosphate Binder OsvaRen®
Source: Urology / Nephrology News From Medical News Today [2009.11.12]
Fresenius Medical Care, the world's largest provider of dialysis products and services, announces the presentation of the first results from the CALcium acetate MAGnesium carbonate evaluation study (CALMAG study) for the new phosphate binder OsvaRen® at the Renal Week 2009 in San Diego, USA.1 The CALMAG study examines efficacy and safety of OsvaRen®.
Published Studies Related to Phoslo (Calcium Acetate)
A 1-year randomized trial of calcium acetate versus sevelamer on progression of coronary artery calcification in hemodialysis patients with comparable lipid control: the Calcium Acetate Renagel Evaluation-2 (CARE-2) study. [2008.06]
BACKGROUND: Previous clinical trials showed that progression of coronary artery calcification (CAC) may be slower in hemodialysis patients treated with sevelamer than those treated with calcium-based phosphate binders. Because sevelamer decreases low-density lipoprotein cholesterol (LDL-C) levels, we hypothesized that intensive lowering of LDL-C levels with atorvastatin in hemodialysis patients treated with calcium acetate would result in CAC progression rates similar to those in sevelamer-treated patients... CONCLUSIONS: With intensive lowering of LDL-C levels for 1 year, hemodialysis patients treated with either calcium acetate or sevelamer experienced similar progression of CAC.
A comparison of sevelamer and calcium-based phosphate binders on mortality, hospitalization, and morbidity in hemodialysis: a secondary analysis of the Dialysis Clinical Outcomes Revisited (DCOR) Randomized Trial Using Claims Data. [2008.03]
BACKGROUND: The Dialysis Clinical Outcomes Revisited (DCOR) trial, a large, randomized, multicenter, open-label study, compared effects of sevelamer with calcium-based phosphate binders on mortality and hospitalization in hemodialysis patients. Many patients were lost to follow-up, precluding intent-to-treat analysis by using prospective data collection... CONCLUSIONS: In this secondary analysis, treatment with sevelamer versus calcium-based binders did not affect overall mortality (primary outcome), cause-specific mortality, morbidity, or first or cause-specific hospitalization (secondary outcomes), but there was evidence for a beneficial effect on multiple all-cause hospitalizations and hospital days (secondary outcomes).
The interscan variation of CT coronary artery calcification score: analysis of the Calcium Acetate Renagel Comparison (CARE)-2 study. [2008.01]
RATIONALE AND OBJECTIVES: In the Calcium Acetate Renagel Evaluation (CARE)-2 study, the effects of calcium acetate plus atorvastatin (Lipitor) on the progression of coronary artery calcifications (CACs) are evaluated versus those of Renagel, monitored using dual electron beam tomography (EBT) scans (two scans at study initiation and two at follow up). The aim of this study is to estimate the interscan variation for the Agatston score and for the volume score determined in patients with end-stage renal disease (ESRD) in the CARE-2 study... CONCLUSION: Interscan variability was sufficiently small for patients with calcium scores greater than 30. Our study thus demonstrates a sufficient reproducibility of the calcium score using EBT. This score allows for accurate serial assessment of these patients and for comparing different therapies.
Effects of sevelamer and calcium-based phosphate binders on mortality in hemodialysis patients. [2007.11]
Elevated serum phosphorus and calcium are associated with arterial calcification and mortality in dialysis patients. Unlike calcium-based binders, sevelamer attenuates arterial calcification but it is unknown whether sevelamer affects mortality or morbidity...
Comparison of calcium acetate with calcium carbonate as phosphate binder in patients on maintenance haemodialysis. [2007.10]
BACKGROUND: Hyperphosphatemia is common in end-stage renal disease patients. Objective of this study is to compare the hypercalcaemic effect and phosphate binding power of calcium acetate and calcium carbonate in end-stage renal disease patients on maintenance haemodialysis... CONCLUSIONS: It is concluded that calcium acetate has similar effect on serum phosphate levels as compared to calcium carbonate in patients on maintenance haemodialysis. However, calcium acetate results in lesser frequency of hypercalcaemia as compared to calcium carbonate. Tolerance to both drugs was similar, though patients complained of more muscle cramps while taking calcium acetate.
Clinical Trials Related to Phoslo (Calcium Acetate)
CARE-2 (Calcium Acetate [PhosLo®]/Sevelamer[Renagel®] Evaluation Study 2) for Heart Calcification in Dialysis Patients [Completed]
The purpose of the study is to evaluate the effects of two phosphate binders, PhosLo and
sevelamer, on heart calcification in dialysis patients. The study will use a non-invasive
technique, electron beam computed tomography (CT) scanning, to measure calcium in the
coronary arteries, the aortic valve, and the mitral valve.
EPIC(Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease) [Completed]
The purpose of this study is to determine if calcium acetate (PhosLo) can control serum
phosphorus in pre-dialysis patients with moderate to severe impairment of kidney function.
Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers [Recruiting]
To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in
healthy volunteers with calcium citrate as a positive control.
Arterial Stiffness and Calcifications in Haemodialysis Patients on Sevelamer or Calcium Acetate [Not yet recruiting]
End-stage renal disease (ESRD) is a state of increased arterial stiffness of extensive
vessel calcifications, compared with the non-renal population. Both arterial stiffness and
arterial calcifications are potent predictors of all-cause and cardiovascular mortality in
ESRD patients. Several studies have documented the direct relationship between the extent
and severity of arterial/coronary calcifications and outcome in dialysis patients. The
relationship is strong no matter if arterial calcifications were quantified by electron-beam
computed tomography or a radiological calcification score. Calcifications are early and
progressive events in these patients. PWV is strongly related to the degree of sonographic
determined arterial calcifications and EBCT-derived coronary artery calcium score in chronic
kidney disease patients.
Calcium-based phosphate binders are associated with progressive coronary artery and aortic
calcification, especially when mineral metabolism is not well controlled.
According to recent studies, sevelamer hydrochloride is a potent non-calcium-containing
phosphate binder, well tolerated in ESRD. Compared with calcium-based phosphate binders,
sevelamer is less likely to cause hypercalcemia, low levels of PTH, and progressive coronary
and aortic calcification in hemodialysis patients. Moreover, sevelamer has a favorable
effect on the lipid profile.
Less is known about the relationship between sevelamer treatment and progression of arterial
stiffness. To date, there is one single study examining the influence of sevelamer (versus
calcium carbonate) on the evolution of arterial stiffness in a very small number (N=15) of
haemodialysis patients. These study used the same patients as historical controls, thus
being methodologically rather weak. Moreover, the follow-up was quite short - 6 month.
The aim of the trial is to to quantify, in a randomized opened-labeled controlled trial the
effect of sevelamer hydrochloride on the evolution of arterial stiffness parameters (pulse
wave velocity and the augmentation index) in chronic haemodialysis patients and to correlate
these parameters with arterial calcification assessed by a previous described radiological
score of arterial calcification and echocardiographic parameters (left ventricular
hypertrophy, LV dilatation, systolic and diastolic dysfunction).
Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis [Completed]
The purpose of this study is to determine if Renagel® is more effective as a treatment for
patients with peritoneal dialysis compared to calcium acetate.
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