Lanthanum carbonate versus placebo for management of hyperphosphatemia in
patients undergoing peritoneal dialysis: a subgroup analysis of a phase 2
randomized controlled study of dialysis patients.
Author(s): Hutchison AJ(1), Gill M, Copley JB, Poole L, Wilson RJ.
Affiliation(s): Author information:
(1)Manchester Institute of Nephrology and Transplantation, Manchester Royal
Infirmary, University of Manchester, Oxford Road, M13 9WL, Manchester, UK.
alastair.hutchison@cmft.nhs.uk
Publication date & source: 2013, BMC Nephrol. , 14:40
BACKGROUND: This short-term study assessed the efficacy and safety of lanthanum
carbonate in the treatment of hyperphosphatemia in dialysis patients; here, we
report a prespecified subgroup analysis of patients undergoing peritoneal
dialysis.
METHODS: Men and women (n=39) who had received continuous ambulatory peritoneal
dialysis for chronic kidney disease for 6 months or more were enrolled in eight
renal medicine departments in the United Kingdom. A 2-week washout period was
followed by a 4-week dose-titration phase during which patients received
lanthanum carbonate titrated up to 2250 mg/day. This was followed by a 4-week,
randomized, placebo-controlled, parallel-group phase during which patients
continued to receive either lanthanum carbonate at the titrated dose, or a
matched dose of placebo. The main outcome measure was control of serum phosphate
levels (1.3-1.8 mmol/l) at the end of the parallel-group phase.
RESULTS: Serum phosphate was controlled in 3/39 (8%) patients at the beginning of
the dose-titration phase (after washout) and in 18/31 (58%) patients treated with
lanthanum carbonate at its end. After the parallel-group phase, 60% of lanthanum
carbonate-treated patients and 10% of those receiving placebo had controlled
serum phosphate. There was no difference in mean (95% confidence interval) serum
phosphate levels between groups at randomization: lanthanum carbonate, 1.57
(1.34-1.81) mmol/l; placebo, 1.58 (1.40-1.76) mmol/l (p=0.96). However, a
difference was seen at the end of the parallel-group phase: lanthanum carbonate,
1.56 (1.33-1.79) mmol/l; placebo, 2.25 (1.81-2.68) mmol/l (p=0.0015). There were
no clinically important changes in nutritional parameters and no serious
treatment-related adverse events were recorded.
CONCLUSIONS: At doses up to 2250 mg/day, lanthanum carbonate is well tolerated
and controls hyperphosphatemia effectively. Treatment with higher doses of
lanthanum carbonate may allow patients undergoing peritoneal dialysis the
potential to increase their dietary protein intake without compromising their
phosphate control.
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