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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01412398
First Posted: August 9, 2011
Last Update Posted: December 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
August 4, 2011
August 9, 2011
December 7, 2016
April 2009
April 2014   (Final data collection date for primary outcome measure)
  • Incidence of adverse drug reactions in subjects who received Fosrenol [ Time Frame: After Fosrenol administration, up to 1 year ]
  • Incidence of serious adverse events in subjects who received Fosrenol [ Time Frame: After Fosrenol administration, up to 1 year ]
Same as current
Complete list of historical versions of study NCT01412398 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL] [ Time Frame: After Fosrenol administration, up to 1 year ]
  • 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 ]
  • Clinical test value collections [calciotropic hormones, bone turnover markers] [ Time Frame: After Fosrenol administration, up to 1 year ]
Same as current
Not Provided
Not Provided
 
Fosrenol Post-marketing Surveillance for Continuous Cyclic Peritoneal Dialysis in Japan
Special Drug Use Investigation of Fosrenol (Investigation for Patients With Continuous Cyclic Peritoneal Dialysis)
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Hyperphosphatemia
Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet
Patients in CCPD who have received Fosrenol for hyperphosphatemia
Group 1
Drug (incl. Placebo)
Intervention: Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
446
September 2016
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who are contraindicated based on the product label
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01412398
15076
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
December 2016