Renal Failure Chronic
Conditions
Brief 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)
Detailed description
10 weeks including, 2 weeks wash-out period and 8 weeks study treatment period
Interventions
DRUGsevelamer carbonate 800mg
Pharmaceutical form:tablet Route of administration: oral
DRUGsevelamer carbonate 2.4 g
Pharmaceutical form:powder Route of administration: oral
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Countries
Russia
Outcome results
None listed