Fosrenol Post-marketing Surveillance in Japan
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperphosphatemia; Kidney Disease
Intervention: Fosrenol (Lanthanum Carbonate, BAY77-1931) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact: Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Summary
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.
Clinical Details
Official title: Drug Use Investigation of Fosrenol for Hyperphosphatemia With Chronic Kidney Disease Not on Dialysis
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Incidence/number of episodes of adverse drug reactions and adverse eventsSerum 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) Serum intact PTH level for six months after start of treatment with the drug in comparison with baseline 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). 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). 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). 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).
Secondary outcome: Incidence/number of episodes of adverse drug reactions and adverse eventsAdverse drug event rate related to the digestive system 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. 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients whom investigators have decided to treat with Lanthanum carbonate for the
first time at the respective medical institutions. Those medical institutions have to
understand the objective of this investigation and conclude a written contract with
Bayer Yakuhin.
- The decision to treat patients with Lanthanum carbonate will be made independently by
the investigator prior to study inclusion.
- Patients treated with Lanthanum carbonate in the indication "Hyperphosphatemia" with
chronic kidney disease not on dialysis".
Exclusion Criteria:
- Patients who are contraindicated based on the product label.
- Patients who have been already treated with Fosrenol
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Many Locations, Japan; Recruiting
Additional Information
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Starting date: October 2013
Last updated: July 23, 2015
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