Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease
Phase 3
Completed
- Conditions
- Kidney Failure, Chronic
- Registration Number
- NCT00151918
- Lead Sponsor
- Shire
- Brief Summary
The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with either lanthanum carbonate or sevelamer hydrochloride
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- Patients receiving haemodialysis for ESRD
- Patients must have received haemodialysis for chronic renal failure three times per week for at least the previous 2 months
Exclusion Criteria
- Pregnant or lactating women
- Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
- Patients who are HIV+
- Patients with any significant bowel obstruction, active inflammatory bowel disease, GI motility disorders, or a history of major GI surgery within the last 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean pre-dialysis serum phosphate level The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
- Secondary Outcome Measures
Name Time Method Treatment emergent adverse events Throughout the study period of approximately 7.5 months. Treatment-emergent adverse events (TEAEs) were defined as AEs that had an onset date and time on or after the date and time of the first dose of study medication.
Mean pre-dialysis serum calcium product The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8) Mean pre-dialysis calcium-phosphate product The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8) Average daily pill burden Daily throughout for the 8 week Evaluation for Dose Adjustment Period up to the End of Study/ Withdrawal Visit.