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A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

This study is currently recruiting participants.
Verified December 2012 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01742585
First received: December 4, 2012
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

This is a randomized, double blind, placebo-controlled multi-center study to examine the efficacy and safety of ASP1585 in chronic kidney disease patients with hyperphosphatemia not on dialysis.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ASP1585 Phase 3 Randomized Double Blind Placebo-controlled Study in Chronic Kidney Disease (CKD) 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:
  • Change from baseline in serum phosphorus level at the end of treatment [ Time Frame: Baseline and Week 12 or treatment discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Achievement rate of the target range of serum phosphorus level [ Time Frame: During 12 week treatment ] [ Designated as safety issue: No ]
  • Time to achieve the target range of serum phosphorus level [ Time Frame: During 12 week treatment ] [ Designated as safety issue: No ]
  • Time-course changes in serum phosphorus levels [ Time Frame: During 12 week treatment ] [ Designated as safety issue: No ]
  • Time-course changes in serum calcium levels [ Time Frame: During 12 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 12 week treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP1585 group Drug: ASP1585
oral
Other Names:
  • LY101
  • AMG223
  • bixalomer
Placebo Comparator: placebo group Drug: placebo
oral

  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 (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 within 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742585

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: NCT01742585     History of Changes
Other Study ID Numbers: 1585-CL-0101
Study First Received: December 4, 2012
Last Updated: December 6, 2012
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 21, 2013