Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients

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

Official Title
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A Double-blind, Randomized, Placebo-controlled Multi-center Trial to Compare the Phosphate Lowering Efficacy of Different Doses of SBR759 to Placebo

Conditions
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Hyperphosphatemia, Chronic Kidney Disease

Intervention / Treatment
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* Drug: SBR759A
* Drug: SBR759A
* Drug: SBR759A
* Drug: SBR759A
* Drug: SBR759A


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Men or women of at least 18 years of age Stable maintenance of hemodialysis 3 times per week for 3 months or greater Controlled serum phosphate if under phosphate-binder therapy 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: Patients who are on peritoneal dialysis Patients who have a transplant or parathyroidectomy scheduled during the study Clinically significant GI disorder Unstable medical condition other than Chronic Kidney Disease Patient is currently being treated with oral iron History of hemachromatosis, or ferritin > 1000 ng/mL Transferrin saturation > 60% Uncontrolled hyperparathyroidism (iPTH > 84.8 pmol/L) Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 1<br>Placebo | Drug: SBR759A<br>* Placebo Comparator 0g daily<br>|
| Experimental: Arm 3<br> | Drug: SBR759A<br>* SBR759A 6g daily<br>|
| Experimental: Arm 2<br> | Drug: SBR759A<br>* SBR759A 3g daily<br>|
| Experimental: arm 4<br>SBR759A | Drug: SBR759A<br>* 9g daily<br>|
| Experimental: arm 5<br> | Drug: SBR759A<br>* 12g daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment |  | 6 weeks | 
| Evaluate dose-dependent efficacy of SBR759 |  | 6 weeks | 
| Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease, Hemodialysis, Hyperphosphatemia, Hyperphosphatemia patients with chronic kidney disease on 3x/week hemodialysis