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Completed

NCT Number: NCT01419327

Fosrenol Post-marketing Surveillance for Hemodialysis in Japan

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.

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Key information

Conditions

Hyperphosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia

Exclusion criteria

  • Patients who are contraindicated based on the product label

Treatment and study plan

Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet

Drug

Patients in hemodialysis who have received Fosrenol for hyperphosphatemia.

Primary outcomes

  1. Incidence of adverse drug reactions in subjects who received Fosrenol

    Time frame: After Fosrenol administration, up to 8 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Special Drug Use Investigation of Fosrenol (Long-term Investigation for Patients With Hemodialysis)

Acronym: FOSRENOL-HD

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Aug 18, 2011
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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