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Completed

NCT Number: NCT00567723

Long Term Treatment of End Stage Renal Disease Patients With Lanthanum Carbonate (Fosrenol)

Patients who have been treated with Fosrenol for a minimum of 12 consecutive weeks and are receiving dialysis will be followed for 5 years to compare mortality, bone fractures and incidence of selected morbidities to patients with no lanthanum exposure and to patients being treated for hyperphosphatemia with any marketed product.

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Key information

Conditions

Hyperphosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Research Center, Inc., Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Test Group

  • Signed informed consent
  • Patient must have ESRD and be receiving dialysis
  • Prior treatment with Fosrenol for a minimum of 12 consecutive weeks
  • Primary payer of healthcare must be Medicare (patient must supply Medicare Claim Number)
  • Patient must be 18 years of age or older

Exclusion criteria

Test Group

  • Patients that do not meet inclusion criteria

Treatment and study plan

Primary outcomes

  1. Compare all-cause mortality and bone fractures among three groups of subjects with end stage renal disease (ESRD)

    Time frame: 5 years

Secondary outcomes

  1. Compare the incidence of selected morbidities among three groups of patients with ESRD

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Phase-IV, Long-term, Observational Safety Study in End Stage Renal Disease Subjects Treated With Lanthanum Carbonate (Fosrenol)

Important dates

Study start
2006
Primary completion
2016
Study completion
2016
First posted
Dec 5, 2007
Registry last updated
Mar 17, 2021

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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