Status:
COMPLETED
An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Chronic Kidney Disease
Hyperphosphatemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00681941
Start Date
January 1 2006
End Date
March 1 2007
Last Update
March 20 2015
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Nephrology Department, Princess Alexandra Hospital
Wooloongabba, Queensland, Australia, 4102
2
Renal Unit, The Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
3
Renal Research Unit, Launceston General Hospital
Launceston, Tasmania, Australia, 7250
4
The Royal Melbourne Hospital, Department of Nephrology
Parkville, Victoria, Australia, 3050