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

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Drug: Sevelamer HCl; Drug: SBR759

Study type: Interventional

Funder types: Industry

Identifiers

NCT00704678

CSBR759A2202

Details and patient eligibility

About

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

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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203 participants in 4 patient groups

1

Experimental group

Description:

1g bid

Treatment:

Drug: SBR759

2

Active Comparator group

Description:

0.8 g tid

Treatment:

Drug: Sevelamer HCl

Drug: Sevelamer HCl

Drug: Sevelamer HCl

3

Experimental group

Description:

1.5 g tid

Treatment:

Drug: Sevelamer HCl

Drug: Sevelamer HCl

Drug: Sevelamer HCl

4

Active Comparator group

Description:

1.6 g tid

Treatment:

Drug: Sevelamer HCl

Drug: Sevelamer HCl

Drug: Sevelamer HCl