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

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.
 
ClinicalTrials.gov Identifier: NCT01419327
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

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

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Study Type : Observational
Actual Enrollment : 3267 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of Fosrenol (Long-term Investigation for Patients With Hemodialysis)
Actual Study Start Date : March 23, 2009
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : May 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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




Primary Outcome Measures :
  1. Incidence of adverse drug reactions in subjects who received Fosrenol [ Time Frame: After Fosrenol administration, up to 8 years ]

Secondary Outcome Measures :
  1. Timing of onset of common ADRs related to the priority survey items [ Time Frame: After Fosrenol administration, up to 8 years ]

    The items are

    • Gastrointestinal symptoms
    • Secondary hyperparathyroidism
    • Hypocalcaemia and decreased blood calcium

  2. Effect on bones: Alkaline phosphatase over time [ Time Frame: After Fosrenol administration, up to 8 years ]
  3. Effect on bones: Change in bone density [ Time Frame: After Fosrenol administration, up to 8 years ]
  4. Cardiothoracic ratio over time [ Time Frame: After Fosrenol administration, up to 8 years ]
  5. PWV and ABI over time [ Time Frame: After Fosrenol administration, up to 8 years ]
  6. Serum P, albumin-corrected serum Ca and serum intact PTH, and Ca-P product over time [ Time Frame: After Fosrenol administration, up to 8 years ]
  7. Percentage of patients achieving the serum P control goal [ Time Frame: After Fosrenol administration, up to 8 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia

Exclusion Criteria:

  • Patients who are contraindicated based on the product label

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): NCT01419327


Locations
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Japan
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01419327    
Other Study ID Numbers: 15077
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Keywords provided by Bayer:
Fosrenol
Hyperphosphatemia
Hemodialysis
Additional relevant MeSH terms:
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Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases