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Fosrenol Post-marketing Surveillance for Continuous Cyclic Peritoneal Dialysis in Japan (FOSRENOL-CAPD)

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ClinicalTrials.gov Identifier: NCT01412398
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : January 19, 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 continuous ambulatory peritoneal dialysis (CAPD) who have received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. This study is also all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited and followed one year.

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

Study Type : Observational
Actual Enrollment : 446 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of Fosrenol (Investigation for Patients With Continuous Ambulatory Peritoneal Dialysis)
Actual Study Start Date : April 7, 2009
Actual Primary Completion Date : April 8, 2014
Actual Study Completion Date : September 1, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1
Drug (incl. Placebo)
Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet
Patients in CAPD 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 1 year ]
  2. Incidence of serious adverse events in subjects who received Fosrenol [ Time Frame: After Fosrenol administration, up to 1 year ]

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 1 year ]
  2. Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL] [ Time Frame: After Fosrenol administration, up to 1 year ]
  3. Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL] [ Time Frame: After Fosrenol administration, up to 1 year ]
  4. Clinical test value collections [calciotropic hormones, bone turnover markers] [ Time Frame: After Fosrenol administration, up to 1 year ]


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study is all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited.
Criteria

Inclusion Criteria:

  • Patients undergoing continuous ambulatory peritoneal dialysis 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): NCT01412398


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01412398     History of Changes
Other Study ID Numbers: 15076
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Keywords provided by Bayer:
Fosrenol
Hyperphosphatemia
Continuous Cyclic Peritoneal Dialysis

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases