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A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis

Primary Purpose

Hyperphosphatemia, Chronic Kidney Disease

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

ASP1585

Placebo

Sevelamer hydrochloride

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring ASP1585, Renal Dialysis, Chronic Kidney Disease, Hyperphosphatemia

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Stable CKD patients who are currently on hemodialysis three times a week for at least 12 weeks prior to the acquisition of informed consent
Patients on stable dose(s) of phosphate binder(s) for at least 28 days prior to the acquisition of informed consent.
Patients on stable dose(s) of Vitamin D or calcitonin agent for at least 28 days prior to the acquisition of informed consent, in case patients are treated by those agents

Exclusion Criteria:

History of major gastrointestinal surgery, or swallowing disorders, bowel obstruction, hemorrhagic gastrointestinal lesion
Continuous severe constipation/diarrhea.
History of parathyroid intervention [parathyroidectomy（PTx），percutaneous ethanol injection therapy（PEIT）etc.] within 1 year of the acquisition of informed consent
Diet restriction such as fasting and/or excessive dieting
Uncontrolled hypertension

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

ASP1585 dose #1

ASP1585 dose #2

ASP1585 dose #3

Placebo

Sevelamer hydrochloride

Arm Description

Outcomes

Primary Outcome Measures

Change in serum phosphorus

Secondary Outcome Measures

Change in serum phosphorus level by time

Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time

Change in corrected serum Ca level

Change in Ca×P

Change in intact PTH

Full Information

NCT ID

NCT00505037

First Posted

July 18, 2007

Last Updated

March 21, 2011

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT00505037

Brief Title

A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis

Official Title

A Phase 2, Randomized, Double-blind-placebo-controlled and Open-label-Sevelamer Hydrochloride-controlled, Dose-ranging Study for ASP1585 in Patients With Chronic Kidney Disease(CKD) and Hyperphosphatemia on Hemodialysis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To evaluate the superiority to placebo, dose-responsibility and safety.

Detailed Description

This is a multi-center, randomized, double blind placebo-controlled and open label sevelamer hydrochloride-controlled, dose-ranging study in CKD patients with hyperphosphatemia on hemodialysis. Patients will be randomly allocated to one of the five treatment groups (ASP1585: 3 dose, placebo, Sevelamer hydrochloride) and advance to the 4-week treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperphosphatemia, Chronic Kidney Disease

Keywords

ASP1585, Renal Dialysis, Chronic Kidney Disease, Hyperphosphatemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

156 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ASP1585 dose #1

Arm Type

Experimental

Arm Title

ASP1585 dose #2

Arm Type

Experimental

Arm Title

ASP1585 dose #3

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Sevelamer hydrochloride

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

ASP1585

Intervention Description

Oral

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral

Intervention Type

Drug

Intervention Name(s)

Sevelamer hydrochloride

Intervention Description

Oral

Primary Outcome Measure Information:

Title

Change in serum phosphorus

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Change in serum phosphorus level by time

Time Frame

Up to 4 weeks

Title

Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time

Time Frame

4 Weeks

Title

Change in corrected serum Ca level

Time Frame

4 weeks

Title

Change in Ca×P

Time Frame

4 weeks

Title

Change in intact PTH

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Stable CKD patients who are currently on hemodialysis three times a week for at least 12 weeks prior to the acquisition of informed consent Patients on stable dose(s) of phosphate binder(s) for at least 28 days prior to the acquisition of informed consent. Patients on stable dose(s) of Vitamin D or calcitonin agent for at least 28 days prior to the acquisition of informed consent, in case patients are treated by those agents Exclusion Criteria: History of major gastrointestinal surgery, or swallowing disorders, bowel obstruction, hemorrhagic gastrointestinal lesion Continuous severe constipation/diarrhea. History of parathyroid intervention [parathyroidectomy（PTx），percutaneous ethanol injection therapy（PEIT）etc.] within 1 year of the acquisition of informed consent Diet restriction such as fasting and/or excessive dieting Uncontrolled hypertension

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Use Central Contact

Organizational Affiliation

Astellas Pharma Inc

Official's Role

Study Chair

Facility Information:

City

Chubu

Country

Japan

City

Chugoku

Country

Japan

City

Kansai

Country

Japan

City

Kanto

Country

Japan

City

Kyushu

Country

Japan

City

Shikoku

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

24975892

Citation

Akizawa T, Origasa H, Kameoka C, Kaneko Y, Kanoh H. Dose-finding study of bixalomer in patients with chronic kidney disease on hemodialysis with hyperphosphatemia: a double-blind, randomized, placebo-controlled and sevelamer hydrochloride-controlled open-label, parallel group study. Ther Apher Dial. 2014 Jun;18 Suppl 2:24-32. doi: 10.1111/1744-9987.12202.

Results Reference

derived

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A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis

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