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

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ClinicalTrials.gov Identifier: NCT01419327
Recruitment Status : Active, not recruiting
First Posted : August 18, 2011
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

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

Study Type : Observational
Actual Enrollment : 3267 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of Fosrenol (Long-term Investigation for Patients With Hemodialysis)
Actual Study Start Date : March 23, 2009
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1
Drug (incl. Placebo)
Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet
Patients in hemodialysis who have received Fosrenol for hyperphosphatemia.



Primary Outcome Measures :
  1. Incidence of adverse drug reactions in subjects who received Fosrenol [ Time Frame: After Fosrenol administration, up to 5 years ]
  2. Incidence of serious adverse events in subjects who received Fosrenol [ Time Frame: After Fosrenol administration, up to 5 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL] [ Time Frame: After Fosrenol administration, up to 5 years ]
  3. 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 ]
  4. Clinical test value collection: calciotropic hormones [ Time Frame: After Fosrenol administration, up to 5 years ]
  5. Clinical test value collection: bone turnover markers [ Time Frame: After Fosrenol administration, up to 5 years ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419327


Locations
Japan
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01419327     History of Changes
Other Study ID Numbers: 15077
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Keywords provided by Bayer:
Fosrenol
Hyperphosphatemia
Hemodialysis

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases