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

March 21, 2011 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu, Japan
      • Chugoku, Japan
      • Kansai, Japan
      • Kanto, Japan
      • Kyushu, Japan
      • Shikoku, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral
Active Comparator: Sevelamer hydrochloride
Drug: Sevelamer hydrochloride
Oral
Experimental: ASP1585 dose #1
Drug: ASP1585
Oral
Experimental: ASP1585 dose #2
Drug: ASP1585
Oral
Experimental: ASP1585 dose #3
Drug: ASP1585
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in serum phosphorus
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in serum phosphorus level by time
Time Frame: Up to 4 weeks
Up to 4 weeks
Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time
Time Frame: 4 Weeks
4 Weeks
Change in corrected serum Ca level
Time Frame: 4 weeks
4 weeks
Change in Ca×P
Time Frame: 4 weeks
4 weeks
Change in intact PTH
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

July 18, 2007

First Submitted That Met QC Criteria

July 18, 2007

First Posted (Estimate)

July 20, 2007

Study Record Updates

Last Update Posted (Estimate)

March 22, 2011

Last Update Submitted That Met QC Criteria

March 21, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1585-CL-0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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