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A Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal Dialysis

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ClinicalTrials.gov Identifier: NCT01017276
Recruitment Status : Completed
First Posted : November 20, 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 in chronic kidney disease and hyperphosphatemia patients on peritoneal dialysis.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Study in Patients With Chronic Kidney Disease (CKD) With Hyperphosphatemia on Peritoneal Dialysis
Study Start Date : November 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: ASP group Drug: ASP1585
oral
Other Names:
  • ILY101
  • AMG223




Primary Outcome Measures :
  1. Serum phosphorus level at treatment discontinuation [ Time Frame: During the 12-week treatment period ]

Secondary Outcome Measures :
  1. Percent of the patients meeting the target range of serum phosphorus levels [ Time Frame: During treatment ]
  2. Time-course changes in serum calcium levels [ Time Frame: During Treatment ]
  3. Changes in serum Ca x P [ Time Frame: During Treatment ]
  4. Changes in intact PTH levels [ Time Frame: During Treatment ]


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

Inclusion Criteria:

  • Chronic kidney disease patients on peritoneal dialysis
  • Hyperphosphatemia
  • Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not 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

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): NCT01017276


Locations
Japan
Chubu, Japan
Chugoku, 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: NCT01017276     History of Changes
Other Study ID Numbers: 1585-CL-0005
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: May 4, 2015
Last Verified: April 2015

Keywords provided by Astellas Pharma Inc:
Hyperphosphatemia
Peritoneal dialysis
CKD
ASP1585

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Hyperphosphatemia
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases