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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01057407
First Posted: January 27, 2010
Last Update Posted: May 4, 2015
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):
Astellas Pharma Inc
January 25, 2010
January 27, 2010
May 4, 2015
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 ]
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 ]
  • Time-course changes in serum phosphorus levels [ Time Frame: During Treatment ]
  • Changes in serum Ca x P [ Time Frame: During treatment ]
  • Changes in intact PTH levels [ Time Frame: During Treatment ]
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
Intervention Model: Parallel Assignment
Masking: None (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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01057407
1585-CL-0003
No
Not Provided
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
April 2015

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