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A Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal Dialysis

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01017276
Collaborator
(none)
35
Enrollment
3
Locations
1
Arm
10
Duration (Months)
11.7
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 in chronic kidney disease and hyperphosphatemia patients on peritoneal dialysis.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Study in Patients With Chronic Kidney Disease (CKD) With Hyperphosphatemia on Peritoneal Dialysis
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: ASP group

Drug: ASP1585
oral
Other Names:
  • ILY101
  • AMG223

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum phosphorus level at treatment discontinuation [During the 12-week treatment period]

    Secondary Outcome Measures

    1. Percent of the patients meeting the target range of serum phosphorus levels [During treatment]

    2. Time-course changes in serum calcium levels [During Treatment]

    3. Changes in serum Ca x P [During Treatment]

    4. Changes in intact PTH levels [During Treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Chronic kidney disease patients on peritoneal dialysis

    • Hyperphosphatemia

    • Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not changed within 28 days.

    • 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

    Locations

    Site City State Country Postal Code
    1 Chubu Japan
    2 Chugoku Japan
    3 Kantou Japan

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Chair: Use Central Contact, Astellas Pharma Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT01017276
    Other Study ID Numbers:
    • 1585-CL-0005
    First Posted:
    Nov 20, 2009
    Last Update Posted:
    May 4, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Astellas Pharma Inc
    Hyperphosphatemia
    Peritoneal dialysis
    CKD
    ASP1585
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Renal Insufficiency
    Hyperphosphatemia

    Study Results

    No Results Posted as of May 4, 2015