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

Astellas

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease; Renal Insufficiency; Renal Dialysis

Treatments: Drug: ASP1585; Drug: Sevelamer hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01057407

1585-CL-0003

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

ASP group

Experimental group

Treatment:

Drug: ASP1585

Sevelamer group

Active Comparator group

Treatment:

Drug: Sevelamer hydrochloride