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

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.
ClinicalTrials.gov Identifier: NCT00505037
Recruitment Status : Completed
First Posted : July 20, 2007
Last Update Posted : March 22, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
To evaluate the superiority to placebo, dose-responsibility and safety.

Condition or disease Intervention/treatment Phase
Hyperphosphatemia Chronic Kidney Disease Drug: ASP1585 Drug: Placebo Drug: Sevelamer hydrochloride Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : October 2007
Primary Completion Date : September 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ASP1585 dose #1 Drug: ASP1585
Oral
Experimental: ASP1585 dose #2 Drug: ASP1585
Oral
Experimental: ASP1585 dose #3 Drug: ASP1585
Oral
Placebo Comparator: Placebo Drug: Placebo
Oral
Active Comparator: Sevelamer hydrochloride Drug: Sevelamer hydrochloride
Oral


Outcome Measures

Primary Outcome Measures :
  1. Change in serum phosphorus [ Time Frame: 4 weeks ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505037


Locations
Japan
Chubu, Japan
Chugoku, Japan
Kansai, Japan
Kanto, Japan
Kyushu, Japan
Shikoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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
First Posted: July 20, 2007    Key Record Dates
Last Update Posted: March 22, 2011
Last Verified: March 2011

Keywords provided by Astellas Pharma Inc:
ASP1585
Renal Dialysis
Chronic Kidney Disease
Hyperphosphatemia

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