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A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

Primary Purpose

Chronic Kidney Disease, Renal Insufficiency, Hyperphosphatemia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
ASP1585
placebo
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring CKD, Not on dialysis, ASP1585, Bixalomer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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:

  • 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 within 6 months

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ASP1585 group

placebo group

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in serum phosphorus level at the end of treatment

Secondary Outcome Measures

Achievement rate of the target range of serum phosphorus level
Time to achieve the target range of serum phosphorus level
Time-course changes in serum phosphorus levels
Time-course changes in serum calcium levels
Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs

Full Information

First Posted
December 4, 2012
Last Updated
July 15, 2014
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01742585
Brief Title
A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
Official Title
ASP1585 Phase 3 Randomized Double Blind Placebo-controlled Study in Chronic Kidney Disease (CKD) Patients With Hyperphosphatemia Not on Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, double blind, placebo-controlled multi-center study to examine the efficacy and safety of ASP1585 in chronic kidney disease patients with hyperphosphatemia not on dialysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Renal Insufficiency, Hyperphosphatemia
Keywords
CKD, Not on dialysis, ASP1585, Bixalomer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASP1585 group
Arm Type
Experimental
Arm Title
placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ASP1585
Other Intervention Name(s)
LY101, AMG223, bixalomer
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Change from baseline in serum phosphorus level at the end of treatment
Time Frame
Baseline and Week 12 or treatment discontinuation
Secondary Outcome Measure Information:
Title
Achievement rate of the target range of serum phosphorus level
Time Frame
During 12 week treatment
Title
Time to achieve the target range of serum phosphorus level
Time Frame
During 12 week treatment
Title
Time-course changes in serum phosphorus levels
Time Frame
During 12 week treatment
Title
Time-course changes in serum calcium levels
Time Frame
During 12 week treatment
Title
Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs
Time Frame
During 12 week treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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: 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 within 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Chubu
Country
Japan
City
Hokkaido
Country
Japan
City
Kansai
Country
Japan
City
Kanto
Country
Japan
City
Kyushu
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

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