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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01057407
First Posted: January 27, 2010
Last Update Posted: May 4, 2015
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.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
This is a multi-center, open-labeled study to examine the non-inferiority of ASP1585 to sevelamer hydrochloride in chronic kidney disease patients with hyperphosphatemia on hemodialysis.

Condition Intervention Phase
Chronic Kidney Disease Renal Dialysis Renal Insufficiency Drug: ASP1585 Drug: Sevelamer hydrochloride Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-label, Sevelamer Hydrochloride-controlled Study in Chronic Kidney Disease (CKD) Patients With Hyperphosphatemia on Hemodialysis

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Serum phosphorus level at the end of treatment [ Time Frame: After 12-week or at the treatment discontinuation ]

Secondary Outcome Measures:
  • Change in serum phosphorus level [ Time Frame: After 12-week or at the end of treatment ]
  • Time-course changes in serum phosphorus levels [ Time Frame: During Treatment ]
  • Changes in serum Ca x P [ Time Frame: During treatment ]
  • Changes in intact PTH levels [ Time Frame: During Treatment ]

Enrollment: 110
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP group Drug: ASP1585
oral
Other Names:
  • ILY101
  • AMG223
Active Comparator: Sevelamer group Drug: Sevelamer hydrochloride
oral
Other Names:
  • Renagel
  • phosbloc

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Chronic kidney disease patients on hemodialysis
  • Hyperphosphatemia
  • Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not been changed within 28 days
  • Written informed consent

Exclusion Criteria:

  • Patients with gastrointestinal surgery or enterectomy
  • Patients with severe cardiac diseases
  • Patients with severe constipation or diarrhea
  • Patients with a history or complication of malignant tumors
  • Patients with uncontrolled hypertension
  • Patients treated with parathyroid intervention
  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): NCT01057407


Locations
Japan
Chubu, Japan
Kantou, Japan
Kyusyu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01057407     History of Changes
Other Study ID Numbers: 1585-CL-0003
First Submitted: January 25, 2010
First Posted: January 27, 2010
Last Update Posted: May 4, 2015
Last Verified: April 2015

Keywords provided by Astellas Pharma Inc:
Hyperphosphatemia
hemodialysis
CKD
ASP1585

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