NCT00892749

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

May 4, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

April 30, 2009

Last Update Submit

April 30, 2015

Conditions

Chronic Kidney DiseaseRenal DialysisRenal InsufficiencyHyperphosphatemia

Keywords

hyperphosphatemiahemodialysisCKDASP1585

Outcome Measures

Primary Outcomes (1)

  • Changes in serum Phosphorus level

    After 48 weeks

Secondary Outcomes (4)

  • Percent of the patients meeting the target range of serum Phosphorus levels

    During the treatment

  • Changes in serum Calcium level

    After 48 weeks

  • Changes in serum Ca x P

    After 48 weeks

  • Changes in intact PTH level

    After 48 weeks

Study Arms (1)

1. ASP1585

EXPERIMENTAL
Drug: ASP1585

Interventions

ASP1585DRUG

oral

Also known as: ILY101, AMG223
1. ASP1585

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicRenal InsufficiencyHyperphosphatemia

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPhosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 4, 2009

Study Start

May 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 4, 2015

Record last verified: 2015-04

Locations

JP(4)