an open label, dose titration study of sevelamer carbonate tablets & powder in hyperphosphatemic ckd patients

Conditions: Renal Failure Chronic

Summary: 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)

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

Eligibility criteria:
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.