Fosrenol Post-marketing Surveillance in Japan

NCT01955876 — Completed, 343 participants, Bayer

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

Registry	NCT01955876
Status	Completed
Study type	Observational
Enrollment	343 (Actual)
Sponsor	Bayer (Industry)
Conditions	Hyperphosphatemia, Kidney Disease
Interventions	Lanthanum Carbonate (Fosrenol, BAY77-1931) (Drug)
Dates	start 2013-10-10, primary completion 2016-02-18, completion 2016-08-05, first posted 2013-10-08, last updated 2018-02-23
Locations	1 site in Japan

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group 1		Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931)

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

+Outcome measures

Primary outcomes

Incidence/number of episodes of adverse drug reactions and adverse events [6 months after start of treatment with the drug]

Secondary outcomes

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)]

+Eligibility

Sex: All

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 (1)

Facility	City	Country	Status
	Multiple Locations	Japan

+Investigators

Bayer Study Director, Study director, Bayer