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

This study is currently recruiting participants.
Verified July 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: July 8, 2013
Last verified: July 2013
  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:


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
Recruiting
Chubu, Japan
Recruiting
Hokkaido, Japan
Recruiting
Kansai, Japan
Recruiting
Kanto, Japan
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: July 8, 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 April 17, 2014