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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01742585
First received: December 4, 2012
Last updated: July 15, 2014
Last verified: July 2014
  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:


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 ]

Enrollment: 163
Study Start Date: October 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742585

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

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: July 15, 2014
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
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 20, 2014