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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00505037
• Other study ID #: 1585-CL-0002
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2007
• Last updated: March 21, 2011
• Start date: October 2007
• Est. completion date: September 2008

Study information

• Verified date: March 2011
• 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

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• ASP1585
Oral
• Placebo
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	Change in serum phosphorus		4 weeks	No
Secondary	Change in serum phosphorus level by time		Up to 4 weeks	No
Secondary	Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time		4 Weeks	No
Secondary	Change in corrected serum Ca level		4 weeks	No
Secondary	Change in Ca×P		4 weeks	No
Secondary	Change in intact PTH		4 weeks	No