An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis

Study Overview
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Brief Summary
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Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 14 weeks.

Official Title
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An Open Label, Dose Titration of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis

Conditions
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Chronic Kidney Disease, Hyperphosphatemia

Intervention / Treatment
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* Drug: Sevelamer carbonate (Renvela®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A minimum of 120 male and female patients with chronic kidney disease not requiring dialysis will be screened for participation in the study. Men or woman 18 years of age or older If currently taking phosphate binder(s), willing to stop this and enter a 2 week washout period Willing to avoid any intentional changes in diet such as fasting or dieting Have the following central laboratory measurements: 1. If not on a phosphate binder, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) at Screening (Visit1). 2. If taking a phosphate binder(s) at screening, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) after the two-week washout period at Visit 1a (Day 0). At Screening (Visit 1), have the following central laboratory measurements: 1. 25-hydroxyvitamin D ≥ 10 ng/mL 2. iPTH ≤ 800 pg/mL Willing and able to take sevelamer carbonate alone as a phosphate binder for the duration of the study Willing and able to maintain screening doses of lipid medication, 1,25 dihydroxyvitamin D, and/or cinacalcet for the duration of the study, except for safety reasons Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement If female and of childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or IUDs Expecting not to initiate dialysis for the duration of this study Considered compliant with phosphate binders (if applicable) Willing and able to provide informed consent Has not participated in any other investigational drug studies within 30 days prior to enrollment, Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel Exclusion Criteria: Active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal (GI) motility disorders Active ethanol or drug abuse, excluding tobacco use Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders. In the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition Pregnant or breast-feeding Evidence of active malignancy except for basal cell carcinoma of the skin Unable to comply with the requirements of the study Known hypersensitivity to sevelamer or any constituents of the study drug Any other condition, which in the opinion of the investigator will prohibit the patient's inclusion in the study

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Sevelamer Carbonate Tablets Dosed Three Times A Day | Drug: Sevelamer carbonate (Renvela®)<br>* Sevelamer Carbonate Tablets Dosed Three Times A Day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of sevelamer carbonate tablets dosed three times per day (TID) with meals on control of serum phosphorus levels |  | Up to day 70 | 
| Evaluate the safety and tolerability of sevelamer carbonate tablets dosed TID with meals. |  | Up to day 70 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum calcium-phosphorus product |  | Up to day 70 | 
| Serum lipid profile [total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol] |  | Up to day 70 | 
| Percent responders [serum phosphorus between 2.7 and 4.6 mg/dL (0.87 and 1.49 mmol/L) inclusive] at Day 56/ET |  | Up to day 70 |