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A 12-week, open label, multicenter, titration study, with a 9- month maintenance treatment extension, to demonstrate efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in ...

Update Il y a 4 ans
Reference: EUCTR2006-001787-23

A 12-week, open label, multicenter, titration study, with a 9- month maintenance treatment extension, to demonstrate efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis

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Extract

This study is designed to demonstrate superior or at least non-inferior efficacy of SBR759 in phoshate binding, versus sevelamer HCl and evaluate safety over a long term exposure. Efficacy will be measured by the number of patients with a serum phosphate level below or equal to 5.5 mg/dl (i.e. 1.78 mmol/L) at 12 weeks

Inclusion criteria

  • Hyperphosphataemia in patients with Chronic Kidney Disease (CKD) on hemodialysis

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