This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
115
Novartis Investigative Site
Jette, Belgium
Novartis Investigative Site
Liège, Belgium
Novartis Investigative Site
Roeselare, Belgium
Novartis Investigative Site
Brescia, Italy
Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment
Time frame: 6 weeks
Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment
Time frame: 6 weeks
Evaluate dose-dependent efficacy of SBR759
Time frame: 6 weeks
Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
9g daily
12g daily
Novartis Investigative Site
Lecco, Italy
Novartis Investigator Site
Lucca, Italy
Novartis Investigative Site
Napoli, Italy
Novartis Investigative Site
Pavia, Italy
Novartis Investigative Site
Siena, Italy