BAY 77-1931 Long-term Extension From Phase II Study
Phase 2
Completed
- Conditions
- Hyperphosphatemia
- Interventions
- Drug: BAY 77-1931
- Registration Number
- NCT00769496
- Lead Sponsor
- Bayer
- Brief Summary
A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
Inclusion Criteria
- Undergoing hemodialysis 3 times per week for chronic renal failure for the previous 3 consecutive months at least
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Exclusion Criteria
- Pre-dialysis serum phosphate levels of 10.0mg/dL during the washout period
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 BAY 77-1931 -
- Primary Outcome Measures
Name Time Method Changes in pre-dialysis serum phosphate levels Every 4 weeks
- Secondary Outcome Measures
Name Time Method Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL) Every 4 weeks Changes in corrected serum calcium level Every 4 weeks Changes in the product of serum calcium and phosphate Every 4 weeks Changes in serum intact-PHT levels Every 4 weeks Changes in bone metabolism markers Every 4 weeks