An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients

Study Overview
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Brief Summary
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Primary Objective: Evaluate the reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis Secondary Objective: Evaluate the safety on the basis of adverse events, changes in laboratory values and vital signs from baseline (Day 0) to Day 56 (End of treatment/ End of Study)

Detailed Description
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10 weeks including, 2 weeks wash-out period and 8 weeks study treatment period

Official Title
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An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic Chronic Kidney Disease Patients

Conditions
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Renal Failure Chronic

Intervention / Treatment
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* Drug: sevelamer carbonate 800mg
* Drug: sevelamer carbonate 2.4 g


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Men or women 18 years of age or older suffering from CKD not on dialysis or on a stable haemodialysis regimen If currently on 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 laboratory measurement: iPTH ≤ 1000 pg/mL at screening (including results obtained within 60 days prior to screening) If not taking a phosphate binder, a serum phosphorus measurement >5.5 mg/dL (1.78 mmol/L) at Screening (Visit 1). If taking a phosphate binder at screening, a serum phosphorus measurement > 5.5 mg/dL (1.78 mmol/L) after the two-weeks washout period at Visit 1a (Day 0). Willing and able to take Sevelamer carbonate alone as a phosphate binder for the duration of the study Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study Willing and able to maintain screening doses of vitamin D, and/or cinacalcet for the duration of the study, except for safety reasons If female and childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or intrauterine devices For patients not on dialysis expecting not to initiate dialysis for the duration of this study Signed 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 dysphagia or swallowing disorder Predisposition or current bowel obstruction, Severe gastrointestinal (GI) motility disorders including severe constipation 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 Planned renal transplant or parathyroidectomy within 3 months of Visit 1 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 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD patients not on dialysis 800 mg<br>Sevelamer carbonate 800 mg in tabs 3 times per day with meals | Drug: sevelamer carbonate 800mg<br>* Pharmaceutical form:tablet Route of administration: oral<br>* Other names: Renvela;|
| Experimental: CKD patients not on dialysis 2.4 g<br>Sevelamer carbonate 2.4 g powder carbonate per day | Drug: sevelamer carbonate 2.4 g<br>* Pharmaceutical form:powder Route of administration: oral<br>* Other names: Renvela;|
| Experimental: CKD patients on dialysis 800 mg<br>Sevelamer carbonate 800 mg in tabs 3 times per day with meals | Drug: sevelamer carbonate 800mg<br>* Pharmaceutical form:tablet Route of administration: oral<br>* Other names: Renvela;|
| Experimental: CKD patients on dialysis 2.4 g<br>Sevelamer carbonate 2.4 g powder carbonate per day | Drug: sevelamer carbonate 2.4 g<br>* Pharmaceutical form:powder Route of administration: oral<br>* Other names: Renvela;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis |  | up to 8 weeks |