check_circleStudy Completed

Hyperphosphatemia

Bayer Identifier:

15076

ClinicalTrials.gov Identifier:

NCT01412398

EudraCT Number:

Not Available

EU CT Number:

Not Available
Fosrenol post-marketing surveillance for continuous cyclic peritoneal dialysis in Japan

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

13 - N/A
  • - Patients undergoing continuous ambulatory peritoneal dialysis who received Fosrenol for hyperphosphatemia
  • - Patients who are contraindicated based on the product label

Trial summary

Enrollment Goal
446
Trial Dates
April 2009 - September 2016
Phase
Phase 4
Could I Receive a placebo
No
Products
Fosrenol (Lanthanum Carbonate, BAY77-1931)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Incidence of adverse drug reactions in subjects who received Fosrenol
    date_rangeTime Frame:
    After Fosrenol administration, up to 1 year
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of serious adverse events in subjects who received Fosrenol
    date_rangeTime Frame:
    After Fosrenol administration, up to 1 year
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • 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
    date_rangeTime Frame:
    After Fosrenol administration, up to 1 year
    enhanced_encryption
    Safety Issue:
    Yes
  • Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL]
    date_rangeTime Frame:
    After Fosrenol administration, up to 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL]
    date_rangeTime Frame:
    After Fosrenol administration, up to 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Clinical test value collections [calciotropic hormones, bone turnover markers]
    date_rangeTime Frame:
    After Fosrenol administration, up to 1 year
    enhanced_encryption
    Safety Issue:
    No

Trial design

Special drug use investigation of Fosrenol (investigation for patients with continuous ambulatory peritoneal dialysis)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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