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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 events

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)

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 events

Adverse 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

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: October 2013
Last updated: July 23, 2015

Page last updated: August 23, 2015

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