We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01017276
First Posted: November 20, 2009
Last Update Posted: May 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
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
oral
Other Names:
  • ILY101
  • AMG223

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 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
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
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01017276     History of Changes
Other Study ID Numbers: 1585-CL-0005
First Submitted: November 19, 2009
First Posted: November 20, 2009
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