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NCT00892749 Clinical Trial

Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis

Chronic Kidney Disease Clinical Trial

Official title:
A Phase 3, Long-term Study in Patients With Chronic Kidney Disease (CKD) and Hyperphosphatemia on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00892749
Other study ID # 1585-CL-0004
Secondary ID
Status Completed
Phase Phase 3
First received April 30, 2009
Last updated April 30, 2015
Start date May 2009
Est. completion date September 2010

Study information
Verified date April 2015
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease and hyperphosphatemia patients on hemodialysis.

Recruitment information / eligibility
Status Completed
Enrollment 248
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Chronic kidney disease patients on hemodialysis

- Hyperphosphatemia

- Written informed consent

Exclusion Criteria:

- Patients with gastrointestinal surgery or enterectomy

- Severe cardiac disease patients

- Patients with severe constipation or diarrhea

- Patients with a complication of malignant tumors

- Patients with uncontrolled hypertension

- Patients treated with parathyroid intervention

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ASP1585
oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in serum Phosphorus level After 48 weeks No
Secondary Percent of the patients meeting the target range of serum Phosphorus levels During the treatment No
Secondary Changes in serum Calcium level After 48 weeks No
Secondary Changes in serum Ca x P After 48 weeks No
Secondary Changes in intact PTH level After 48 weeks No
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