Overview

Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
This study will determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Sevelamer
Criteria
Inclusion criteria

- Men or women of at least 18 years old or 20 years old in Japan.

- Stable maintenance of hemodialysis 3 times per week.

- Controlled serum phosphate if under phosphate-binder therapy.

- Serum phosphate level > 6.0 mg/dL (> 1.9 mmol/L) prior to study treatment initiation.

Exclusion criteria

- Peritoneal dialysis or a non-conventional hemodialysis technique .

- Parathyroidectomy or transplant scheduled during the study.

- Uncontrolled hyperparathyroidism

- History of hemochromatosis or ferritin > 800 µg/L.

- Clinically significant GI disorder

- Unstable medical condition other than Chronic Kidney Disease.

- Treated with sevelamer HCl monotherapy or SBR759.

- Treated with oral iron.

- Other protocol-defined inclusion/exclusion criteria may apply.