A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis

Study Overview
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Brief Summary
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The primary objective of this study is to assess the safety, tolerability and activity of escalating multiple doses of SBR759 in patients with chronic kidney disease on hemodialysis.

Official Title
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An Open Label, Multiple Dose, Time-lagged, Switch Study to Evaluate the Safety, Tolerability and Activity of Escalating SBR759 Doses in Patients With Chronic Kidney Disease on Hemodialysis

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: SBR759
* Drug: SBR759
* Drug: SBR759
* Drug: SBR759
* Drug: SBR759
* Drug: SBR759
* Drug: SBR759


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be treated with maintenance hemodialysis and prescribed a phosphate binder. A controlled serum phosphorus. Constant dose of concomitant medications. Women of child bearing potential must be practicing an acceptable form of birth control (i.e. double barrier method - intrauterine device plus condom, spermicidal gel plus condom). All female patients must have a negative pregnancy test at screening in order to be eligible to participate in the study. Exclusion Criteria: Patient has been hospitalized within 30 days prior to screening or has a surgery scheduled during the study. Patient has an unstable medical condition, an active infection, active malignancy (except for basal cell carcinoma of the skin), a history of major GI tract surgery, or a history of hemochromatosis. Patient is receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to screening. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: SBR759<br>* Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.<br>|
| Experimental: 2<br> | Drug: SBR759<br>* Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.<br>|
| Experimental: 3<br> | Drug: SBR759<br>* Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.<br>|
| Experimental: 4<br> | Drug: SBR759<br>* Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.<br>|
| Experimental: 5<br> | Drug: SBR759<br>* Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.<br>|
| Experimental: 6<br> | Drug: SBR759<br>* Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.<br>|
| Experimental: 7<br> | Drug: SBR759<br>* Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In addition to the standard safety assessments (vital signs, ECGs, clinical chemistry and adverse events), serum phosphorus concentration is frequently measured during the study. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Several biomarkers and patient-reported outcomes are assessed at specified time points, before and after treating patients with the study drug. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic kidney disease,, hemodialysis,, serum phosphorus,, phosphate binders