| Trial ID: | L0665 |
| Source ID: | NCT01955876
|
| Associated Drug: |
Lanthanum Carbonate (Fosrenol, Bay77-1931)
|
| Title: |
Fosrenol Post-marketing Surveillance in Japan
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hyperphosphatemia|Kidney Disease
|
| Interventions: |
DRUG: Lanthanum Carbonate (Fosrenol, BAY77-1931)
|
| Outcome Measures: |
Primary: Incidence/number of episodes of adverse drug reactions and adverse events, 6 months after start of treatment with the drug | Secondary: Incidence/number of episodes of adverse drug reactions and adverse events, until the conduction of dialysis after starting the treatment with Lanthanum carbonate(Maximum 2 years)|Adverse drug event rate related to the digestive system, until the conduction of dialysis(Maximum 2 years)|Incidence/number of episodes of adverse events for 6, 12 months ,and from month 13 to the conduction of dialysis after starting the treatment with Lanthanum carbonate., until the conduction of dialysis(Maximum 2 years)|Incidence/number of episodes of adverse drug reactions for 6, 12 months ,and from month 13 to the conduction of dialysis after starting the treatment with Lanthanum carbonate according to patient characteristics and treatment with Lanthanum carbonate., until the conduction of dialysis(Maximum 2 years)|Serum P level for six months after start of treatment with the drug in comparison with baseline (at the time of start of treatment with fosrenol), 6 months after start of treatment with the drug|Serum intact PTH level for six months after start of treatment with the drug in comparison with baseline, 6 months after start of treatment with the drug|Serum P level at 12 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Fosrenol)., 12 months|Serum P level at the conduction of dialysis from 13 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Fosrenol)., until the conduction of dialysis(Maximum 2 years)|Serum intact PTH level at 12 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Lanthanum carbonate)., 12 months|Serum intact PTH level at the conduction of dialysis from 13 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Lanthanum carbonate)., until the conduction of dialysis(Maximum 2 years)
|
| Sponsor/Collaborators: |
Sponsor: Bayer
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
343
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2013-10-10
|
| Completion Date: |
2016-08-05
|
| Results First Posted: |
|
| Last Update Posted: |
2018-02-23
|
| Locations: |
Multiple Locations, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01955876
|
