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

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.
 
ClinicalTrials.gov Identifier: NCT01742585
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Kidney Disease Renal Insufficiency Hyperphosphatemia Drug: ASP1585 Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ASP1585 group Drug: ASP1585
oral
Other Names:
  • LY101
  • AMG223
  • bixalomer

Placebo Comparator: placebo group Drug: placebo
oral




Primary Outcome Measures :
  1. Change from baseline in serum phosphorus level at the end of treatment [ Time Frame: Baseline and Week 12 or treatment discontinuation ]

Secondary Outcome Measures :
  1. Achievement rate of the target range of serum phosphorus level [ Time Frame: During 12 week treatment ]
  2. Time to achieve the target range of serum phosphorus level [ Time Frame: During 12 week treatment ]
  3. Time-course changes in serum phosphorus levels [ Time Frame: During 12 week treatment ]
  4. Time-course changes in serum calcium levels [ Time Frame: During 12 week treatment ]
  5. Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs [ Time Frame: During 12 week treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01742585


Locations
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Japan
Chubu, Japan
Hokkaido, Japan
Kansai, Japan
Kanto, Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01742585    
Other Study ID Numbers: 1585-CL-0101
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014
Keywords provided by Astellas Pharma Inc:
CKD
Not on dialysis
ASP1585
Bixalomer
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Hyperphosphatemia
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases