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A Phase 2 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:
NCT00505037
First received: July 18, 2007
Last updated: March 21, 2011
Last verified: March 2011
History of Changes

July 18, 2007
March 21, 2011
October 2007
September 2008   (final data collection date for primary outcome measure)
Change in serum phosphorus [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change in serum phosphorus [ Time Frame: 4 weeks ]
Complete list of historical versions of study NCT00505037 on ClinicalTrials.gov Archive Site
  • Change in serum phosphorus level by time [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
  • Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Change in corrected serum Ca level [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in Ca×P [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in intact PTH [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change in serum phosphorus level by time Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time Change in corrected serum Ca level Change in Ca×P Change in intact PTH [ Time Frame: 4 weeks ]
Not Provided
Not Provided
 
A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis
A Phase 2, Randomized, Double-blind-placebo-controlled and Open-label-Sevelamer Hydrochloride-controlled, Dose-ranging Study for ASP1585 in Patients With Chronic Kidney Disease(CKD) and Hyperphosphatemia on Hemodialysis

To evaluate the superiority to placebo, dose-responsibility and safety.

This is a multi-center, randomized, double blind placebo-controlled and open label sevelamer hydrochloride-controlled, dose-ranging study in CKD patients with hyperphosphatemia on hemodialysis. Patients will be randomly allocated to one of the five treatment groups (ASP1585: 3 dose, placebo, Sevelamer hydrochloride) and advance to the 4-week treatment period.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hyperphosphatemia
  • Chronic Kidney Disease
  • Drug: ASP1585
    Oral
  • Drug: Placebo
    Oral
  • Drug: Sevelamer hydrochloride
    Oral
  • Experimental: ASP1585 dose #1
    Intervention: Drug: ASP1585
  • Experimental: ASP1585 dose #2
    Intervention: Drug: ASP1585
  • Experimental: ASP1585 dose #3
    Intervention: Drug: ASP1585
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Sevelamer hydrochloride
    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
156
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Stable CKD patients who are currently on hemodialysis three times a week for at least 12 weeks prior to the acquisition of informed consent
  • Patients on stable dose(s) of phosphate binder(s) for at least 28 days prior to the acquisition of informed consent.
  • Patients on stable dose(s) of Vitamin D or calcitonin agent for at least 28 days prior to the acquisition of informed consent, in case patients are treated by those agents

Exclusion Criteria:

  • History of major gastrointestinal surgery, or swallowing disorders, bowel obstruction, hemorrhagic gastrointestinal lesion
  • Continuous severe constipation/diarrhea.
  • History of parathyroid intervention [parathyroidectomy（PTx），percutaneous ethanol injection therapy（PEIT）etc.] within 1 year of the acquisition of informed consent
  • Diet restriction such as fasting and/or excessive dieting
  • Uncontrolled hypertension
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00505037
1585-CL-0002
Yes
Director, Astellas Pharma Inc.
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
March 2011

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