Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00892749
First received: April 30, 2009
Last updated: March 21, 2011
Last verified: March 2011
  Purpose

This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease and hyperphosphatemia patients on hemodialysis.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Long-term Study 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:
  • Changes in serum Phosphorus level [ Time Frame: After 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of the patients meeting the target range of serum Phosphorus levels [ Time Frame: During the treatment ] [ Designated as safety issue: No ]
  • Changes in serum Calcium level [ Time Frame: After 48 weeks ] [ Designated as safety issue: No ]
  • Changes in serum Ca x P [ Time Frame: After 48 weeks ] [ Designated as safety issue: No ]
  • Changes in intact PTH level [ Time Frame: After 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 248
Study Start Date: May 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. ASP1585 Drug: ASP1585
oral
Other Names:
  • ILY101
  • AMG223

  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
  • Written informed consent

Exclusion Criteria:

  • Patients with gastrointestinal surgery or enterectomy
  • Severe cardiac disease patients
  • Patients with severe constipation or diarrhea
  • Patients with a 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: NCT00892749

Locations
Japan
Chubu, Japan
Chugoku, Japan
Kansai, Japan
Kantou, 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: NCT00892749     History of Changes
Other Study ID Numbers: 1585-CL-0004
Study First Received: April 30, 2009
Last Updated: March 21, 2011
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

ClinicalTrials.gov processed this record on April 17, 2014