check_circleStudy Completed
Hyperphosphatemia
Bayer Identifier:
11551
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
BAY 77-1931 Long-term Extension from Phase II Study
Trial purpose
A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis
Key Participants Requirements
Sex
BothAge
20 - 75 YearsTrial summary
Enrollment Goal
145Trial Dates
January 2005 - May 2008Phase
Phase 2Could I Receive a placebo
NoProducts
Fosrenol (Lanthanum Carbonate, BAY77-1931)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Mihama Hospital | Chiba, 261-0011, Japan |
Completed | Shin Kashiwa Clinic | Kashiwa, 277-0084, Japan |
Completed | Ama Kyoritsu Clinic | Yatomi, 498-0006, Japan |
Completed | Kawashima Hospital | Tokushima, 770-0011, Japan |
Completed | Shimazu Hospital | Kochi, 780-0066, Japan |
Completed | Kochi Takasu Hospital | Kochi, 781-5103, Japan |
Completed | Kitasaito Hospital | Asahikawa, 070-0030, Japan |
Completed | Inoue Hospital | Suita, 564-0053, Japan |
Completed | Mihama Narita Clinic | Narita, 286-0041, Japan |
Completed | Mihama Shizu Clinic | Sakura, 285-0846, Japan |
Completed | Meiyo Clinic | Toyohashi, 441-8023, Japan |
Completed | Shigei Medical Research Hospital | Okayama, 701-0202, Japan |
Completed | Nakajima Tsuchiya Clinic | Hiroshima, 730-0811, Japan |
Completed | Koseinenkin Kochi Rehabilitation Hospital | Kochi, 780-8040, Japan |
Completed | Kawashima Cardiovascular Clinic | Tokushima, 770-0011, Japan |
Primary Outcome
- Changes in pre-dialysis serum phosphate levelsdate_rangeTime Frame:Every 4 weeksenhanced_encryptionyesSafety Issue:
Secondary Outcome
- Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)date_rangeTime Frame:Every 4 weeksenhanced_encryptionyesSafety Issue:
- Changes in corrected serum calcium leveldate_rangeTime Frame:Every 4 weeksenhanced_encryptionyesSafety Issue:
- Changes in the product of serum calcium and phosphatedate_rangeTime Frame:Every 4 weeksenhanced_encryptionyesSafety Issue:
- Changes in serum intact-PHT levelsdate_rangeTime Frame:Every 4 weeksenhanced_encryptionyesSafety Issue:
- Changes in bone metabolism markersdate_rangeTime Frame:Every 4 weeksenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1