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

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ClinicalTrials.gov Identifier: NCT00892749
Recruitment Status : Completed
First Posted : May 4, 2009
Last Update Posted : May 4, 2015
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Kidney Disease Renal Dialysis Renal Insufficiency Hyperphosphatemia Drug: ASP1585 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Long-term Study in Patients With Chronic Kidney Disease (CKD) and Hyperphosphatemia on Hemodialysis
Study Start Date : May 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1. ASP1585 Drug: ASP1585
oral
Other Names:
  • ILY101
  • AMG223



Primary Outcome Measures :
  1. Changes in serum Phosphorus level [ Time Frame: After 48 weeks ]

Secondary Outcome Measures :
  1. Percent of the patients meeting the target range of serum Phosphorus levels [ Time Frame: During the treatment ]
  2. Changes in serum Calcium level [ Time Frame: After 48 weeks ]
  3. Changes in serum Ca x P [ Time Frame: After 48 weeks ]
  4. Changes in intact PTH level [ Time Frame: After 48 weeks ]


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
  • 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

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): 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

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00892749     History of Changes
Other Study ID Numbers: 1585-CL-0004
First Posted: May 4, 2009    Key Record Dates
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