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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 18, 2007

Last Updated Date

November 3, 2008

Start Date ^†

October 2007

Current Primary Outcome Measures ^†

Change in serum phosphorus [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00505037 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Change in serum phosphorus level by time [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Change in corrected serum Ca level [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change in Ca×P [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change in intact PTH [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original 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 [ Time Frame: 4 weeks ]

Descriptive Information

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

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Hyperphosphatemia
Chronic Kidney Disease

Intervention ^†

Drug: ASP1585
Drug: Placebo
Drug: Sevelamer hydrochloride

Study Arms / Comparison Groups

Experimental: ASP1585 dose #1
Experimental: APS1585 dose #2
Experimental: ASP1585 dose #3

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

156

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00505037

Responsible Party

Director, Astellas Pharma Inc.

Secondary IDs ^††

Study Sponsor ^†

Astellas Pharma Inc

Collaborators ^††

Investigators ^†

Study Chair:

Use Central Contact

Astellas Pharma Inc

Information Provided By

Astellas Pharma Inc

Verification Date

November 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.