Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc

Criteria

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