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

This study is currently recruiting participants.
Verified April 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01419327
First received: August 17, 2011
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of Fosrenol (Long-term Investigation for Patients With Hemodialysis)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 3000
Study Start Date: March 2009
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Drug (incl. Placebo)
Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet
Patients in hemodialysis who have received Fosrenol for hyperphosphatemia.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia

Exclusion Criteria:

  • Patients who are contraindicated based on the product label
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419327

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Japan
Recruiting
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01419327     History of Changes
Other Study ID Numbers: 15077
Study First Received: August 17, 2011
Last Updated: April 1, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Fosrenol
Hyperphosphatemia
Hemodialysis

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014