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A Comparative 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:
NCT01057407
First received: January 25, 2010
Last updated: October 18, 2010
Last verified: October 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum phosphorus level [ Time Frame: After 12-week or at the end of treatment ] [ Designated as safety issue: No ]
  • Time-course changes in serum phosphorus levels [ Time Frame: During Treatment ] [ Designated as safety issue: No ]
  • Changes in serum Ca x P [ Time Frame: During treatment ] [ Designated as safety issue: No ]
  • Changes in intact PTH levels [ Time Frame: During Treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01057407     History of Changes
Other Study ID Numbers: 1585-CL-0003
Study First Received: January 25, 2010
Last Updated: October 18, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
Hyperphosphatemia
hemodialysis
CKD
ASP1585

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

ClinicalTrials.gov processed this record on June 17, 2013