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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 : December 7, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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 cyclic peritoneal dialysis (CCPD) 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 CCPD who received Fosrenol for hyperphosphatemia will be recruited and followed one year.

Condition or disease Intervention/treatment Phase
Hyperphosphatemia Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet Phase 4

Study Design

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 Cyclic Peritoneal Dialysis)
Study Start Date : April 2009
Primary Completion Date : April 2014
Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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 CCPD who received Fosrenol for hyperphosphatemia will be recruited.
Criteria

Inclusion Criteria:

  • Patients undergoing continuous cyclic peritoneal dialysis who received Fosrenol for hyperphosphatemia

Exclusion Criteria:

  • Patients who are contraindicated based on the product label
Contacts and Locations

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

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: December 7, 2016
Last Verified: December 2016

Keywords provided by Bayer:
Fosrenol
Hyperphosphatemia
Continuous Cyclic Peritoneal Dialysis

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases