This study is a regulatory post-marketing surveillance in Japan and it is a local prospective and observational study of patients who have received Fosrenol. The objective of this research is to collect information on the safety of Fosrenol after its launching, which means collecting information on adverse events, especially adverse events in the digestive system including constipation and serious adverse events, and adverse drug reactions when the drug is administered to the below-mentioned target patients for six months. The secondary objective is to collect information on the safety of the drug when administered for more than six months, which means collecting information on the safety of the drug when administered for up to 12 months to the target patients who have already been treated with the drug for six months. And also if at the time of 12 months after administration of Lanthanum carbonate the dialysis is not conducted, extending its' administration will be continued until conduction of dialysis, or until Sept. 30, 2015. The efficacy of fosrenol is evaluated by observing the serum P(phosphorus) level and serum PTH (parathyroid hormone) level change.
Study Type
OBSERVATIONAL
Enrollment
343
Patients treated with Fosrenol in daily clinical practice.
Unnamed facility
Multiple Locations, Japan
Incidence/number of episodes of adverse drug reactions and adverse events
Time frame: 6 months after start of treatment with the drug
Incidence/number of episodes of adverse drug reactions and adverse events
Time frame: until the conduction of dialysis after starting the treatment with Lanthanum carbonate(Maximum 2 years)
Adverse drug event rate related to the digestive system
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: until the conduction of dialysis(Maximum 2 years)
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