Fosrenol Post-marketing Surveillance for Hemodialysis in Japan (FOSRENOL-HD)

This study is currently recruiting participants.

Verified June 2013 by Bayer

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT01419327

First received: August 17, 2011

Last updated: June 16, 2013

Last verified: June 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 17, 2011

Last Updated Date

June 16, 2013

Start Date ^ICMJE

March 2009

Estimated Primary Completion Date

October 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of adverse drug reactions in subjects who received Fosrenol [ Time Frame: After Fosrenol administration, up to 5 years ] [ Designated as safety issue: Yes ]
Incidence of serious adverse events in subjects who received Fosrenol [ Time Frame: After Fosrenol administration, up to 5 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01419327 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of adverse drug reactions in subpopulation with baseline data [such as demographic data, concomitant disease, duration of treatment, maximum daily dose] and dose of Fosrenol [ Time Frame: After Fosrenol administration, up to 5 years ] [ Designated as safety issue: Yes ]
Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL] [ Time Frame: After Fosrenol administration, up to 5 years ] [ Designated as safety issue: No ]
Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL] [ Time Frame: After Fosrenol administration, up to 5 years ] [ Designated as safety issue: No ]
Clinical test value collection: calciotropic hormones [ Time Frame: After Fosrenol administration, up to 5 years ] [ Designated as safety issue: No ]
Clinical test value collection: bone turnover markers [ Time Frame: After Fosrenol administration, up to 5 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Incidence of adverse drug reactions in subpopulation with baseline data [such as demographic data, concomitant disease, duration of treatment, maximum daily dose] and dose of Fosrenol [ Time Frame: After Fosrenol administration, up to 5 years ] [ Designated as safety issue: Yes ]
Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL] [ Time Frame: After Fosrenol administration, up to 5 years ] [ Designated as safety issue: No ]
Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL] [ Time Frame: After Fosrenol administration, up to 5 years ] [ Designated as safety issue: No ]
Clinical test value collections [calciotropic hormones, bone turnover markers] [ Time Frame: After Fosrenol administration, up to 5 years ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Fosrenol Post-marketing Surveillance for Hemodialysis in Japan

Official Title ^ICMJE

Special Drug Use Investigation of Fosrenol (Long-term Investigation for Patients With Hemodialysis)

Brief Summary

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in hemodialysis who received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. A total 3,000 patients will be recruited and followed 5 years.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

The target population of this study is patients who have received a prescription of Fosrenol on the basis of the decision of the physician. The study is expected to collect data of 3,000 patients in about 300 practices in Japan.

Condition ^ICMJE

Hyperphosphatemia

Intervention ^ICMJE

Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet

Patients in hemodialysis who have received Fosrenol for hyperphosphatemia.

Study Group/Cohort (s)

Group 1

Drug (incl. Placebo)

Intervention: Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

3000

Estimated Completion Date

October 2016

Estimated Primary Completion Date

October 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia

Exclusion Criteria:

Patients who are contraindicated based on the product label

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01419327

Other Study ID Numbers ^ICMJE

15077

Has Data Monitoring Committee

Responsible Party

Medical Director, Bayer Yakuhin Co.LTD.

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

June 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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