Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease; Hyperphosphatemia

Treatments: Drug: SBR759A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01069692

CSBR759A2304

2008-006097-15 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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115 participants in 5 patient groups, including a placebo group

Arm 1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: SBR759A

Drug: SBR759A

Drug: SBR759A

Drug: SBR759A

Drug: SBR759A

Arm 3

Experimental group

Treatment:

Drug: SBR759A

Drug: SBR759A

Drug: SBR759A

Drug: SBR759A

Drug: SBR759A

Arm 2

Experimental group

Treatment:

Drug: SBR759A

Drug: SBR759A

Drug: SBR759A

Drug: SBR759A

Drug: SBR759A

arm 4

Experimental group

Description:

SBR759A

Treatment:

Drug: SBR759A

Drug: SBR759A

Drug: SBR759A

Drug: SBR759A

Drug: SBR759A

arm 5

Experimental group

Treatment:

Drug: SBR759A

Drug: SBR759A

Drug: SBR759A

Drug: SBR759A

Drug: SBR759A