Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis

Novartis

Status and phase: Completed; Phase 2

Conditions: Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy

Treatments: Drug: Sevelamer HCl; Drug: SBR759

Study type: Interventional

Funder types: Industry

Identifiers

NCT00704483

EUDRACT No.: 2006-001787-23

CSBR759A2201

Details and patient eligibility

About

This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis

Enrollment: 321 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.
• Stable maintenance of renal replacement therapy 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.
• Parathyroidectomy or transplant scheduled during the study.
• Uncontrolled hyperparathyroidism
• History of hemochromatosis or ferritin > 1000 µg/L.
• Clinically significant GI disorder
• Unstable medical condition other than Chronic Kidney Disease.
• 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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321 participants in 4 patient groups

1

Experimental group

Description:

1g tid

Treatment:

Drug: SBR759

Drug: SBR759

2

Active Comparator group

Description:

Sevelamer HCl

Treatment:

Drug: Sevelamer HCl

Drug: Sevelamer HCl

3

Experimental group

Description:

SBR759 1.5 g tid

Treatment:

Drug: SBR759

Drug: SBR759

4

Active Comparator group

Description:

Sevelamer HCl

Treatment:

Drug: Sevelamer HCl

Drug: Sevelamer HCl