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

Astellas

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease; Hyperphosphatemia

Treatments: Drug: ASP1585; Drug: Sevelamer hydrochloride; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00505037

1585-CL-0002

Details and patient eligibility

About

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

Full 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.

Enrollment: 156 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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156 participants in 5 patient groups, including a placebo group

ASP1585 dose #1

Experimental group

Treatment:

Drug: ASP1585

ASP1585 dose #2

Experimental group

Treatment:

Drug: ASP1585

ASP1585 dose #3

Experimental group

Treatment:

Drug: ASP1585

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Sevelamer hydrochloride

Active Comparator group

Treatment:

Drug: Sevelamer hydrochloride