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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01017276
First received: November 19, 2009
Last updated: October 18, 2010
Last verified: October 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of the patients meeting the target range of serum phosphorus levels [ Time Frame: During treatment ] [ Designated as safety issue: No ]
  • Time-course changes in serum calcium levels [ Time Frame: During Treatment ] [ Designated as safety issue: No ]
  • Changes in serum Ca x P [ Time Frame: During Treatment ] [ Designated as safety issue: No ]
  • Changes in intact PTH levels [ Time Frame: During Treatment ] [ Designated as safety issue: No ]

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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Director, Astellas Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01017276     History of Changes
Other Study ID Numbers: 1585-CL-0005
Study First Received: November 19, 2009
Last Updated: October 18, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

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

ClinicalTrials.gov processed this record on May 16, 2013