Trial Condition(s):
Hyperphosphatemia
BAY 77-1931 Long-term Extension from Phase II Study
Bayer Identifier:
11551
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis
Inclusion Criteria
- Undergoing hemodialysis 3 times per week for chronic renal failure for the previous 3 consecutive months at least
Exclusion Criteria
- Pre-dialysis serum phosphate levels of 10.0mg/dL during the washout period
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Chiba, Japan, 261-0011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kashiwa, Japan, 277-0084 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yatomi, Japan, 498-0006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tokushima, Japan, 770-0011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kochi, Japan, 780-0066 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kochi, Japan, 781-5103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Asahikawa, Japan, 070-0030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Suita, Japan, 564-0053 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Narita, Japan, 286-0041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sakura, Japan, 285-0846 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toyohashi, Japan, 441-8023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Okayama, Japan, 701-0202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hiroshima, Japan, 730-0811 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kochi, Japan, 780-8040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A long-term, open label extension, non-controlled study to assess the efficacy and safety of BAY 77-1931 (Lanthanum Carbonate) for hyperphosphatemia in patients undergoing hemodialysis
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 4 weeks
Secondary Outcome
- Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)Timeframe: Every 4 weeks
- Changes in corrected serum calcium levelTimeframe: Every 4 weeks
- Changes in the product of serum calcium and phosphateTimeframe: Every 4 weeks
- Changes in serum intact-PHT levelsTimeframe: Every 4 weeks
- Changes in bone metabolism markersTimeframe: Every 4 weeks
Additional Information
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