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NCT01057407 Clinical Trial

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

Chronic Kidney Disease Clinical Trial

Official title:
A Phase 3, Multicenter, Open-label, Sevelamer Hydrochloride-controlled Study in Chronic Kidney Disease (CKD) Patients With Hyperphosphatemia on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01057407
Other study ID # 1585-CL-0003
Secondary ID
Status Completed
Phase Phase 3
First received January 25, 2010
Last updated April 30, 2015
Start date January 2010
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 study to examine the non-inferiority of ASP1585 to sevelamer hydrochloride in chronic kidney disease patients with hyperphosphatemia on hemodialysis.

Recruitment information / eligibility
Status Completed
Enrollment 110
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

- Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not been changed within 28 days

- Written informed consent

Exclusion Criteria:

- Patients with gastrointestinal surgery or enterectomy

- Patients with severe cardiac diseases

- Patients with severe constipation or diarrhea

- Patients with a history or complication of malignant tumors

- Patients with uncontrolled hypertension

- Patients treated with parathyroid intervention

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ASP1585
oral
• Sevelamer hydrochloride
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 Serum phosphorus level at the end of treatment After 12-week or at the treatment discontinuation No
Secondary Change in serum phosphorus level After 12-week or at the end of treatment No
Secondary Time-course changes in serum phosphorus levels During Treatment No
Secondary Changes in serum Ca x P During treatment No
Secondary Changes in intact PTH levels During Treatment No
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