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A Comparative Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01057407
First received: January 25, 2010
Last updated: October 18, 2010
Last verified: October 2010

January 25, 2010
October 18, 2010
January 2010
September 2010   (final data collection date for primary outcome measure)
Serum phosphorus level at the end of treatment [ Time Frame: After 12-week or at the treatment discontinuation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01057407 on ClinicalTrials.gov Archive Site
  • Change in serum phosphorus level [ Time Frame: After 12-week or at the end of treatment ] [ Designated as safety issue: No ]
  • Time-course changes in serum phosphorus levels [ Time Frame: During Treatment ] [ Designated as safety issue: No ]
  • Changes in serum Ca x P [ Time Frame: During treatment ] [ Designated as safety issue: No ]
  • Changes in intact PTH levels [ Time Frame: During Treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Comparative Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis
A Phase 3, Multicenter, Open-label, Sevelamer Hydrochloride-controlled Study in Chronic Kidney Disease (CKD) Patients With Hyperphosphatemia on Hemodialysis

This is a multi-center, open-labeled study to examine the non-inferiority of ASP1585 to sevelamer hydrochloride in chronic kidney disease patients with hyperphosphatemia on hemodialysis.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Renal Dialysis
  • Renal Insufficiency
  • Drug: ASP1585
    oral
    Other Names:
    • ILY101
    • AMG223
  • Drug: Sevelamer hydrochloride
    oral
    Other Names:
    • Renagel
    • phosbloc
  • Experimental: ASP group
    Intervention: Drug: ASP1585
  • Active Comparator: Sevelamer group
    Intervention: Drug: Sevelamer hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic kidney disease patients on hemodialysis
  • Hyperphosphatemia
  • Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not been changed within 28 days
  • Written informed consent

Exclusion Criteria:

  • Patients with gastrointestinal surgery or enterectomy
  • Patients with severe cardiac diseases
  • Patients with severe constipation or diarrhea
  • Patients with a history or complication of malignant tumors
  • Patients with uncontrolled hypertension
  • Patients treated with parathyroid intervention
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01057407
1585-CL-0003
No
Director, Astellas Pharma, Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
October 2010

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