- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00505037
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
-
-
-
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
|
Oral
|
Active Comparator: Sevelamer hydrochloride
|
Oral
|
Experimental: ASP1585 dose #1
|
Oral
|
Experimental: ASP1585 dose #2
|
Oral
|
Experimental: ASP1585 dose #3
|
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
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.
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
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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