A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis

This study has been completed.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
First received: July 18, 2007
Last updated: March 21, 2011
Last verified: March 2011
To evaluate the superiority to placebo, dose-responsibility and safety.

Condition Intervention Phase
Chronic Kidney Disease
Drug: ASP1585
Drug: Placebo
Drug: Sevelamer hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change in serum phosphorus [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 156
Study Start Date: October 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP1585 dose #1 Drug: ASP1585
Experimental: ASP1585 dose #2 Drug: ASP1585
Experimental: ASP1585 dose #3 Drug: ASP1585
Placebo Comparator: Placebo Drug: Placebo
Active Comparator: Sevelamer hydrochloride Drug: Sevelamer hydrochloride

Detailed Description:
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.

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00505037

Chubu, Japan
Chugoku, Japan
Kansai, Japan
Kanto, Japan
Kyushu, Japan
Shikoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00505037     History of Changes
Other Study ID Numbers: 1585-CL-0002 
Study First Received: July 18, 2007
Last Updated: March 21, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
Renal Dialysis
Chronic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Metabolic Diseases
Phosphorus Metabolism Disorders
Renal Insufficiency
Urologic Diseases
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Sequestering Agents

ClinicalTrials.gov processed this record on May 26, 2016