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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00567723
First received: December 3, 2007
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 2105
Study Start Date: April 2006
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567723

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

No publications provided

Responsible Party: Shire Development LLC
ClinicalTrials.gov Identifier: NCT00567723     History of Changes
Other Study ID Numbers: SPD405-404
Study First Received: December 3, 2007
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013