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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: November 19, 2009
Last updated: April 30, 2015
Last verified: April 2015
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 Intervention Phase
Chronic Kidney Disease Renal Dialysis Renal Insufficiency Drug: ASP1585 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

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

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

Enrollment: 35
Study Start Date: November 2009
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
Other Names:
  • ILY101
  • AMG223


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

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
  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 identifier: NCT01017276

Chubu, Japan
Chugoku, Japan
Kantou, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01017276     History of Changes
Other Study ID Numbers: 1585-CL-0005
Study First Received: November 19, 2009
Last Updated: April 30, 2015

Keywords provided by Astellas Pharma Inc:
Peritoneal dialysis

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases processed this record on August 17, 2017