Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Ferric Compounds

Criteria

Inclusion criteria:

1. Men or women of at least 18 years of age

2. Stable maintenance of hemodialysis 3 times per week for 3 months or greater

3. Controlled serum phosphate if under phosphate-binder therapy

4. 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

Exclusion criteria:

1. Patients who are on peritoneal dialysis

2. Patients who have a transplant or parathyroidectomy scheduled during the study

3. Clinically significant GI disorder

4. Unstable medical condition other than Chronic Kidney Disease

5. Patient is currently being treated with oral iron

6. History of hemachromatosis, or ferritin > 1000 ng/mL

7. Transferrin saturation > 60%

8. Uncontrolled hyperparathyroidism (iPTH > 84.8 pmol/L) Other protocol-defined inclusion/exclusion criteria may apply