NCT01017276

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

3 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

Study Start

First participant enrolled

November 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
10 months 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

10 months

First QC Date

November 19, 2009

Last Update Submit

April 30, 2015

Conditions

Chronic Kidney DiseaseRenal DialysisRenal Insufficiency

Keywords

HyperphosphatemiaPeritoneal dialysisCKDASP1585

Outcome Measures

Primary Outcomes (1)

  • Serum phosphorus level at treatment discontinuation

    During the 12-week treatment period

Secondary Outcomes (4)

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

    During treatment

  • Time-course changes in serum calcium levels

    During Treatment

  • Changes in serum Ca x P

    During Treatment

  • Changes in intact PTH levels

    During Treatment

Study Arms (1)

ASP group

EXPERIMENTAL
Drug: ASP1585

Interventions

ASP1585DRUG

oral

Also known as: ILY101, AMG223
ASP group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, 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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 20, 2009

Study Start

November 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 4, 2015

Record last verified: 2015-04

Locations

JP(3)