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

This study is not yet open for participant recruitment.
Verified February 2013 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01742611
First received: December 4, 2012
Last updated: February 13, 2013
Last verified: February 2013
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Achievement rate of the target range of serum phosphorus level [ Time Frame: During 48 week treatment ] [ Designated as safety issue: No ]
  • Time to achieve the target range of serum phosphorus level [ Time Frame: During 48 week treatment ] [ Designated as safety issue: No ]
  • Time-course changes in serum calcium levels [ Time Frame: During 48 week treatment ] [ Designated as safety issue: No ]
  • Time-course changes in serum intact PTH (parathyroid hormone) levels [ Time Frame: During 48 week treatment ] [ Designated as safety issue: No ]
  • Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs [ Time Frame: During 48 week treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP1585 group Drug: ASP1585
oral
Other Names:
  • LY101
  • AMG223
  • bixalomer

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742611

Contacts
Contact: Clinical Development Administration Dept. clintrialtrials_info@jp.astellas.com

Locations
Japan
Not yet recruiting
Chubu, Japan
Not yet recruiting
Hokkaido, Japan
Not yet recruiting
Kansai, Japan
Not yet recruiting
Kanto, Japan
Not yet recruiting
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01742611     History of Changes
Other Study ID Numbers: 1585-CL-0102
Study First Received: December 4, 2012
Last Updated: February 13, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

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 19, 2013