Long-term Study 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: ASP1585

Study type: Interventional

Funder types: Industry

Identifiers

NCT01742611

1585-CL-0102

Details and patient eligibility

About

This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease patients with hyperphosphatemia not on dialysis.

Enrollment: 105 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who completed study 1585-CL-0101 or new patients who meet following 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

ASP1585 group

Experimental group

Treatment:

Drug: ASP1585