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Completed

NCT Number: NCT01412398

Fosrenol Post-marketing Surveillance for Continuous Cyclic Peritoneal Dialysis in Japan

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.

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Key information

Conditions

Hyperphosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

13 year and older

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 continuous ambulatory peritoneal dialysis 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 CAPD 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 1 year

  2. Incidence of serious adverse events in subjects who received Fosrenol

    Time frame: After Fosrenol administration, up to 1 year

Secondary outcomes

  1. 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

  2. Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL]

    Time frame: After Fosrenol administration, up to 1 year

  3. 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

  4. Clinical test value collections [calciotropic hormones, bone turnover markers]

    Time frame: After Fosrenol administration, up to 1 year

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Special Drug Use Investigation of Fosrenol (Investigation for Patients With Continuous Ambulatory Peritoneal Dialysis)

Acronym: FOSRENOL-CAPD

Important dates

Study start
2009
Primary completion
2014
Study completion
2016
First posted
Aug 9, 2011
Registry last updated
Jan 19, 2018

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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