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CompletedNCT00892749Updated May 4, 2015

Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis

A Phase 3 interventional study of ASP1585 in Chronic Kidney Disease, Renal Dialysis and Renal Insufficiency, sponsored by Astellas Pharma Inc. Completed at 4 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-05-04.

Sponsored by Astellas Pharma Inc · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
248
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study summary

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 and hyperphosphatemia patients on hemodialysis.

02

Conditions studied

  • Chronic Kidney Disease
  • Renal Dialysis
  • Renal Insufficiency
  • Hyperphosphatemia

Keywords

  • hyperphosphatemia
  • hemodialysis
  • CKD
  • ASP1585
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 248 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Chronic kidney disease patients on hemodialysis
  • Hyperphosphatemia
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Patients with gastrointestinal surgery or enterectomy
  • Severe cardiac disease patients
  • Patients with severe constipation or diarrhea
  • Patients with a complication of malignant tumors
  • Patients with uncontrolled hypertension
  • Patients treated with parathyroid intervention
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
248 participants (actual)

Study arms

  • Experimental
    1. ASP1585

    Drug: ASP1585

Interventions

  • DrugASP1585

    oral

    Also known as: ILY101, AMG223

06

What researchers measure

Primary outcomes

  1. Changes in serum Phosphorus level

    Time frame: After 48 weeks

Secondary outcomes

  1. Percent of the patients meeting the target range of serum Phosphorus levels

    Time frame: During the treatment

  2. Changes in serum Calcium level

    Time frame: After 48 weeks

  3. Changes in serum Ca x P

    Time frame: After 48 weeks

  4. Changes in intact PTH level

    Time frame: After 48 weeks

07

Study locations

4 sites
  • Chubu, Japan
  • Chugoku, Japan
  • Kansai, Japan
  • Kantou, Japan
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00892749
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
May 4, 2009
Start date
May 2009
Primary completion
Sep 2010
Completion
Sep 2010
Last update
May 4, 2015

Study contacts

Use Central Contact
study chair · Astellas Pharma Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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