Trial Condition(s):
Hyperphosphatemia, Dialysis
Long-term treatment on BAY77-1931 (lanthanum carbonate) to measure lanthanum concentrations in bone
Bayer Identifier:
11810
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis
Inclusion Criteria
- Patients undergoing dialysis or plan to start dialysis before the initial administration of the study medication
Exclusion Criteria
- Patients with severe hypocalcemia (adjusted serum calcium level of <7.5 mg/dL)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Sanin Rosai Hospital Yonago, Japan, 683-0002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seseragi Hospital Isesaki, Japan, 379-2211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Open label, non-controlled long-term treatment on BAY77-1931 (lanthanum carbonate) to measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Changes in pre-dialysis serum phosphate levelsTimeframe: Every 2 weeks
Secondary Outcome
- Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)Timeframe: Every 2 weeks
- Changes in corrected serum calcium levelTimeframe: Every 2 weeks
- Changes in the product of serum calcium and phosphateTimeframe: Every 2 weeks
- Changes in serum intact-PHT levelsTimeframe: Every 2 weeks
- Changes in bone metabolism markersTimeframe: Every 2 weeks
Additional Information
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