Chronic kidney disease MedDRA version: 8.0 Level: LLT Classification code 10009122
Conditions
Interventions
Product Name: sevelamer carbonate
Product Code: GT335-012
Pharmaceutical Form: Tablet
INN or Proposed INN: sevelamer
CAS Number: 845273-93-0
Current Sponsor code: GT335-012
Other descriptive name: s
Sponsors
Genzyme Europe BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women 18 years of age or older 2. If currently on phosphate binder(s), willing to stop this and enter a 2 week washout period 3. Willing to avoid any intentional changes in diet such as fasting or dieting 4. Have the following central laboratory measurement: a) If not taking a phosphate binder, a serum phosphorus measurement = 5.5 mg/dL (1.76 mmol/L) at Screening (Visit 1). b) If taking a phosphate binder 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). 5. At Screening (Visit 1), have the following central laboratory measurements: a) 25-hydroxyvitamin D >10 ng/mL. b) iPTH = 800 pg/mL 6. Willing and able to take sevelamer carbonate alone as a phosphate binder for the duration of the study 7. 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 8. 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 9. 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 IUDs 10. Expecting not to initiate dialysis for the duration of this study 11. Considered compliant with phosphate binders (if applicable) 12. Willing and able to provide informed consent 13. Has not participated in any other investigational drug studies within 30 days prior to enrollment 14. Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal (GI) motility disorders 2. Active ethanol or drug abuse, excluding tobacco use 3. Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders. 4. 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 5. Pregnant or breast-feeding 6. Evidence of active malignancy except for basal cell carcinoma of the skin 7. Unable to comply with the requirements of the study 8. Known hypersensitivity to sevelamer or any constituents of the study drug 9. Any other condition, which in the opinion of the investigator will prohibit the patient’s inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Evaluate the efficacy of sevelamer carbonate tablets dosed three times a day (TID) with meals on control of serum phosphorus levels - Evaluate the safety and tolerability of sevelamer carbonate tablets dosed TID with meals;Secondary Objective: To evaluate sevelamer carbonate tablets dosed TID with meals on the following: - serum calcium-phosphorus product - serum lipid profile [total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein(LDL) cholesterol] - percent responders [serum phosphorus between 2.7 and 4.6 mg/dL (0.86 and 1.47 mmol/L), inclusive] at Day 56/early termination ;Primary end point(s): Change from baseline to Day 56/early termination in serum phosphorus | — |
Countries
Denmark, Germany, United Kingdom
Outcome results
None listed