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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01412398
First received: August 4, 2011
Last updated: August 10, 2014
Last verified: August 2014

August 4, 2011
August 10, 2014
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 ] [ Designated as safety issue: Yes ]
  • Incidence of serious adverse events in subjects who received Fosrenol [ Time Frame: After Fosrenol administration, up to 1 year ] [ Designated as safety issue: Yes ]
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 ] [ 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 1 year ] [ 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 1 year ] [ Designated as safety issue: No ]
  • Clinical test value collections [calciotropic hormones, bone turnover markers] [ Time Frame: After Fosrenol administration, up to 1 year ] [ Designated as safety issue: No ]
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.
 
Active, not recruiting
3000
October 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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01412398
15076
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP