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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
  Purpose

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


Condition Intervention Phase
Hyperphosphatemia
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
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Astellas Pharma Inc

Additional 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:
ASP1585
Renal Dialysis
Chronic Kidney Disease
Hyperphosphatemia

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

ClinicalTrials.gov processed this record on November 20, 2014