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
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: 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, Chronic
Renal Insufficiency
Hyperphosphatemia
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014