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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 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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Change in serum phosphorus level by time [ Time Frame: Up to 4 weeks ]
  • Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time [ Time Frame: 4 Weeks ]
  • Change in corrected serum Ca level [ Time Frame: 4 weeks ]
  • Change in Ca×P [ Time Frame: 4 weeks ]
  • Change in intact PTH [ Time Frame: 4 weeks ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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 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 Identifier (NCT Number):
Responsible Party: Director, Astellas Pharma Inc. Identifier: NCT00505037     History of Changes
Other Study ID Numbers: 1585-CL-0002
Study First Received: July 18, 2007
Last Updated: March 21, 2011

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

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017