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Randomized Controlled Trial
. 2014 May;29(5):1061-73.
doi: 10.1093/ndt/gft476. Epub 2013 Dec 2.

The effects of colestilan versus placebo and sevelamer in patients with CKD 5D and hyperphosphataemia: a 1-year prospective randomized study

Francesco Locatelli  1 , Goce Spasovski, Nada Dimkovic, Christoph Wanner, Frank Dellanna, Giuseppe Pontoriero
Affiliations
Randomized Controlled Trial

The effects of colestilan versus placebo and sevelamer in patients with CKD 5D and hyperphosphataemia: a 1-year prospective randomized study

Francesco Locatelli et al. Nephrol Dial Transplant. 2014 May.

Abstract

Background: This study compared the effects of short-term titrated colestilan (a novel non-absorbable, non-calcium, phosphate binder) with placebo, and evaluated the safety and efficacy of colestilan over 1 year compared with sevelamer, in patients with chronic kidney disease (CKD) 5D.

Methods: This prospective multicentre study comprised a 4-week phosphate binder washout period, a 16-week short-term, flexible-dose, treatment period (including a 4-week placebo-controlled withdrawal period) and a 40-week extension treatment phase.

Results: At Week 16 (the end of the 4-week placebo-controlled withdrawal period), serum phosphorus level was 0.43 mmol/L (1.32 mg/dL) lower with colestilan than placebo (P < 0.001; primary end point). Serum LDL-C level was also lower with colestilan than with placebo (P < 0.001). Both colestilan and sevelamer produced significant reductions from baseline in serum phosphorus levels (P < 0.001), maintained for 1 year, and the proportion of patients achieving target levels of ≤1.78 mmol/L (5.5 mg/dL) or ≤1.95 mmol/L (6.0 mg/dL) at study end were similar (65.3 and 73.3%, respectively, for colestilan, and 66.9 and 77.4%, respectively, for sevelamer). Serum calcium level remained stable in the colestilan group but tended to increase slightly in the sevelamer group (end-of-study increase of 0.035 mmol/L over baseline). Both binders produced similar reductions from baseline in LDL-C level (P < 0.001), and responder rates after 1 year, using a target of <1.83 mmol/L (70 mg/dL) or <2.59 mmol/L (100 mg/dL) were similar in both groups (50.7 and 85.3% for colestilan and 54.0 and 80.6% for sevelamer). Colestilan was generally well tolerated.

Conclusions: Colestilan is effective and safe for the treatment of hyperphosphataemia in patients with CKD 5D, and affords similar long-term phosphorus and cholesterol reductions/responder rates to sevelamer.

Keywords: chronic kidney disease; colestilan; hyperphosphataemia; placebo; sevelamer.

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Figures

FIGURE 1:
FIGURE 1:
Study design (COL = colestilan, PL = placebo, SEV = sevelamer).
FIGURE 2:
FIGURE 2:
Patient disposition.
FIGURE 3:
FIGURE 3:
Calcium–phosphorus metabolism: change in serum levels of key parameters with colestilan (n = 50) versus placebo (n = 53) at the end of the placebo-controlled withdrawal period (Week 12 to Week 16) [ITT].
FIGURE 4:
FIGURE 4:
Mean serum phosphorus levels during 1 year of treatment with colestilan (n = 75) or sevelamer (n = 124) [ITT] (Error bars indicate standard deviation).
FIGURE 5:
FIGURE 5:
Serum phosphorus responder rates after 1 year of treatment with colestilan versus sevelamer [ITT].
FIGURE 6:
FIGURE 6:
Mean serum calcium levels during 1 year of treatment with colestilan (n = 75) versus sevelamer (n = 124) [ITT].
FIGURE 7:
FIGURE 7:
Serum lipid levels: mean % change with colestilan (n = 50) versus placebo (n = 53) at the end of the placebo-controlled withdrawal period (Week 12 to Week 16) [ITT].
FIGURE 8:
FIGURE 8:
Mean % change from baseline in serum LDL-C level during 1 year of treatment with colestilan (n = 75) versus sevelamer (n = 124) [ITT].
FIGURE 9:
FIGURE 9:
Serum lipid levels: mean % change after 1 year of treatment with colestilan (n = 75) versus sevelamer (n = 124) [ITT].
See this image and copyright information in PMC

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