CompletedPhase 3

Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients

Belgium, Italy115 participantsStarted 2010-02

Plain-language summary

This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Men or women of at least 18 years of age
✓. Stable maintenance of hemodialysis 3 times per week for 3 months or greater
✓. Controlled serum phosphate if under phosphate-binder therapy
✓. Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening

✕. Patients who are on peritoneal dialysis
✕. Patients who have a transplant or parathyroidectomy scheduled during the study
✕. Clinically significant GI disorder
✕. Unstable medical condition other than Chronic Kidney Disease
✕. Patient is currently being treated with oral iron
✕. History of hemachromatosis, or ferritin \> 1000 ng/mL
✕. Transferrin saturation \> 60%
✕. Uncontrolled hyperparathyroidism (iPTH \> 84.8 pmol/L) Other protocol-defined inclusion/exclusion criteria may apply

Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment

Timeframe: 6 weeks

NCT IDNCT01069692

SponsorNovartis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-10