A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

Astellas

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease; Renal Insufficiency; Hyperphosphatemia

Treatments: Drug: placebo; Drug: ASP1585

Study type: Interventional

Funder types: Industry

Identifiers

NCT01742585

1585-CL-0101

Details and patient eligibility

About

This is a randomized, double blind, placebo-controlled multi-center study to examine the efficacy and safety of ASP1585 in chronic kidney disease patients with hyperphosphatemia not on dialysis.

Enrollment: 163 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic kidney disease patients (eGFR < 60 mL/min/1.73 m2)
• Serum phosphorus measurement ≧4.6 mg/dl, <9.0 mg/dl
• 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 within 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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163 participants in 2 patient groups, including a placebo group

ASP1585 group

Experimental group

Treatment:

Drug: ASP1585

placebo group

Placebo Comparator group

Treatment:

Drug: placebo