Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperphosphatemia; Dialysis
Intervention: Lanthanum Carbonate (BAY77-1931) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Summary
To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving
dialysis
Clinical Details
Official title: Open Label, Non-controlled Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone in Patients With Hyperphosphatemia Receiving Dialysis
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Changes in pre-dialysis serum phosphate levels
Secondary outcome: Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)Changes in corrected serum calcium level Changes in the product of serum calcium and phosphate Changes in serum intact-PHT levels Changes in bone metabolism markers
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Isesaki, Gunma 379-2211, Japan
Yonago, Tottori 683-0002, Japan
Additional Information
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Starting date: June 2005
Last updated: June 19, 2014
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