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CompletedNCT01742611Updated Jun 9, 2015

Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

A Phase 3 interventional study of ASP1585 in Chronic Kidney Disease, Renal Insufficiency and Hyperphosphatemia, sponsored by Astellas Pharma Inc. Completed at 5 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-06-09.

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

Phase
Phase 3
Study type
Interventional
Enrollment
105
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 patients with hyperphosphatemia not on dialysis.

02

Conditions studied

  • Chronic Kidney Disease
  • Renal Insufficiency
  • Hyperphosphatemia

Keywords

  • CKD
  • Not on dialysis
  • ASP1585
  • Bixalomer
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 105 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

  • Patients who completed study 1585-CL-0101 or new patients who meet following 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

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
05

Study design

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

Study arms

  • Experimental
    ASP1585 group

    Drug: ASP1585

Interventions

  • DrugASP1585

    oral

    Also known as: LY101, AMG223, bixalomer

06

What researchers measure

Primary outcomes

  1. Time-course changes in serum phosphorus levels

    Time frame: During 48 week treatment

Secondary outcomes

  1. Achievement rate of the target range of serum phosphorus level

    Time frame: During 48 week treatment

  2. Time to achieve the target range of serum phosphorus level

    Time frame: During 48 week treatment

  3. Time-course changes in serum calcium levels

    Time frame: During 48 week treatment

  4. Time-course changes in serum intact PTH (parathyroid hormone) levels

    Time frame: During 48 week treatment

  5. Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs

    Time frame: During 48 week treatment

07

Study locations

5 sites
  • Chubu, Japan
  • Hokkaido, Japan
  • Kansai, Japan
  • Kanto, Japan
  • Kyushu, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01742611
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Dec 5, 2012
Start date
Mar 2013
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Jun 9, 2015

Study contacts

Medical Director
study director · 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 Jun 2015. You cannot join it, but the record below documents what was studied.

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