Fosrenol Post-marketing Surveillance in Japan

Kidney Disease Clinical Trial

Official title:

Drug Use Investigation of Fosrenol for Hyperphosphatemia With Chronic Kidney Disease Not on Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955876
• Other study ID #: 16626
• Secondary ID: FOSRENOL-PRED
• Status: Completed
• Phase: N/A
• First received: September 6, 2013
• Last updated: February 22, 2018
• Start date: October 10, 2013
• Est. completion date: August 5, 2016

Study information

• Verified date: February 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: August 5, 2016
• Est. primary completion date: February 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperphosphatemia
• Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Lanthanum Carbonate (Fosrenol, BAY77-1931)
Patients treated with Fosrenol in daily clinical practice.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)
Secondary	Adverse drug event rate related to the digestive system		until the conduction of dialysis(Maximum 2 years)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)

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