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

This study has been completed.
Information provided by (Responsible Party):
Shire Identifier:
First received: December 3, 2007
Last updated: June 15, 2016
Last verified: June 2016
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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase-IV, Long-term, Observational Safety Study in End Stage Renal Disease Subjects Treated With Lanthanum Carbonate (Fosrenol)

Resource links provided by NLM:

Further study details as provided by Shire:

Primary Outcome Measures:
  • Compare all-cause mortality and bone fractures among three groups of subjects with end stage renal disease (ESRD) [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Compare the incidence of selected morbidities among three groups of patients with ESRD [ Time Frame: 5 years ]

Enrollment: 2105
Study Start Date: April 2006
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Test group: Patients who have received a minimum of 12 consecutive weeks of treatment with Fosrenol
Historical control group: Patients with no lanthanum exposure
Concomitant therapy group: Patients being treated for hyperphosphatemia with any marketed product


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients for the Historical Control and Concomitant Therapy Groups will be selected from the United States Renal Data System (USRDS). The Test Group will consist of patients who have had a minimum of 12 consecutive weeks of exposure to Fosrenol (lanthanum carbonate).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00567723

  Show 199 Study Locations
Sponsors and Collaborators
Principal Investigator: George Porter, MD Oregon Health and Science University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Shire Identifier: NCT00567723     History of Changes
Other Study ID Numbers: SPD405-404
Study First Received: December 3, 2007
Last Updated: June 15, 2016

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases processed this record on September 19, 2017