Back to resultsLong-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone
Primary Purpose
Hyperphosphatemia, Dialysis
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Lanthanum Carbonate (BAY77-1931)
Sponsored by
About this trial
This is an interventional treatment trial for Hyperphosphatemia
Eligibility 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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Changes in pre-dialysis serum phosphate levels
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00767637
Brief Title
Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone
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 Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia, Dialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lanthanum Carbonate (BAY77-1931)
Intervention Description
BAY77-1931 750mg, in the morning, day and evening
Primary Outcome Measure Information:
Title
Changes in pre-dialysis serum phosphate levels
Time Frame
Every 2 weeks
Secondary Outcome Measure Information:
Title
Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)
Time Frame
Every 2 weeks
Title
Changes in corrected serum calcium level
Time Frame
Every 2 weeks
Title
Changes in the product of serum calcium and phosphate
Time Frame
Every 2 weeks
Title
Changes in serum intact-PHT levels
Time Frame
Every 2 weeks
Title
Changes in bone metabolism markers
Time Frame
Every 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Isesaki
State/Province
Gunma
ZIP/Postal Code
379-2211
Country
Japan
City
Yonago
State/Province
Tottori
ZIP/Postal Code
683-0002
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
21426511
Citation
Shigematsu T, Tokumoto A, Nakaoka A, Arisaka H. Effect of lanthanum carbonate treatment on bone in Japanese dialysis patients with hyperphosphatemia. Ther Apher Dial. 2011 Apr;15(2):176-84. doi: 10.1111/j.1744-9987.2010.00898.x.
Results Reference
derived
Learn more about this trial
Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone
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