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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01419327
First received: August 17, 2011
Last updated: July 25, 2014
Last verified: July 2014

August 17, 2011
July 25, 2014
March 2009
October 2016   (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 5 years ] [ Designated as safety issue: Yes ]
  • Incidence of serious adverse events in subjects who received Fosrenol [ Time Frame: After Fosrenol administration, up to 5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01419327 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 5 years ] [ 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 5 years ] [ 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 5 years ] [ Designated as safety issue: No ]
  • Clinical test value collection: calciotropic hormones [ Time Frame: After Fosrenol administration, up to 5 years ] [ Designated as safety issue: No ]
  • Clinical test value collection: bone turnover markers [ Time Frame: After Fosrenol administration, up to 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ 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 5 years ] [ 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 5 years ] [ Designated as safety issue: No ]
  • Clinical test value collections [calciotropic hormones, bone turnover markers] [ Time Frame: After Fosrenol administration, up to 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Fosrenol Post-marketing Surveillance for Hemodialysis in Japan
Special Drug Use Investigation of Fosrenol (Long-term Investigation for Patients With Hemodialysis)

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Hyperphosphatemia
Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet
Patients in hemodialysis 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.
 
Recruiting
3000
October 2016
October 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia

Exclusion Criteria:

  • Patients who are contraindicated based on the product label
Both
Not Provided
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Japan
 
NCT01419327
15077
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
July 2014

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