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Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01742611
First Posted: December 5, 2012
Last Update Posted: June 9, 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 for long-term dosing in chronic kidney disease patients with hyperphosphatemia not on dialysis.

Condition Intervention Phase
Chronic Kidney Disease Renal Insufficiency Hyperphosphatemia Drug: ASP1585 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ASP1585 Phase 3 Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Time-course changes in serum phosphorus levels [ Time Frame: During 48 week treatment ]

Secondary Outcome Measures:
  • Achievement rate of the target range of serum phosphorus level [ Time Frame: During 48 week treatment ]
  • Time to achieve the target range of serum phosphorus level [ Time Frame: During 48 week treatment ]
  • Time-course changes in serum calcium levels [ Time Frame: During 48 week treatment ]
  • Time-course changes in serum intact PTH (parathyroid hormone) levels [ Time Frame: During 48 week treatment ]
  • Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs [ Time Frame: During 48 week treatment ]

Enrollment: 105
Study Start Date: March 2013
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP1585 group Drug: ASP1585
oral
Other Names:
  • LY101
  • AMG223
  • bixalomer

  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:

  • Patients who completed study 1585-CL-0101 or new patients who meet following criteria
  • Chronic kidney disease patients (eGFR < 60 mL/min/1.73 m2)
  • Serum phosphorus measurement ≧4.6 mg/dl, <9.0 mg/dl
  • 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): NCT01742611


Locations
Japan
Chubu, Japan
Hokkaido, Japan
Kansai, Japan
Kanto, Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Inc
  More Information

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01742611     History of Changes
Other Study ID Numbers: 1585-CL-0102
First Submitted: December 4, 2012
First Posted: December 5, 2012
Last Update Posted: June 9, 2015
Last Verified: June 2015

Keywords provided by Astellas Pharma Inc:
CKD
Not on dialysis
ASP1585
Bixalomer

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