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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
ClinicalTrials.gov Identifier:
NCT00567723
First received: December 3, 2007
Last updated: April 3, 2014
Last verified: April 2014

December 3, 2007
April 3, 2014
April 2006
March 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00567723 on ClinicalTrials.gov Archive Site
Compare the incidence of selected morbidities among three groups of patients with ESRD [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Long Term Treatment of End Stage Renal Disease Patients With Lanthanum Carbonate (Fosrenol)
A Phase-IV, Long-term, Observational Safety Study in End Stage Renal Disease Subjects Treated 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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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).

Hyperphosphatemia
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2105
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00567723
SPD405-404
No
Shire
Shire
Not Provided
Principal Investigator: George Porter, MD Oregon Health and Science University
Shire
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP