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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00567723
First Posted: December 5, 2007
Last Update Posted: June 16, 2016
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.
Information provided by (Responsible Party):
Shire
  Purpose
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.

Condition
Hyperphosphatemia

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)
Groups/Cohorts
1
Test group: Patients who have received a minimum of 12 consecutive weeks of treatment with Fosrenol
2
Historical control group: Patients with no lanthanum exposure
3
Concomitant therapy group: Patients being treated for hyperphosphatemia with any marketed product

  Eligibility

Information from the National Library of Medicine

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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).
Criteria

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
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): NCT00567723


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00567723     History of Changes
Other Study ID Numbers: SPD405-404
First Submitted: December 3, 2007
First Posted: December 5, 2007
Last Update Posted: June 16, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases