Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis

Astellas

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease; Renal Insufficiency; Hyperphosphatemia; Renal Dialysis

Treatments: Drug: ASP1585

Study type: Interventional

Funder types: Industry

Identifiers

NCT00892749

1585-CL-0004

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 and hyperphosphatemia patients on hemodialysis.

Enrollment: 248 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic kidney disease patients on hemodialysis
• Hyperphosphatemia
• Written informed consent

Exclusion criteria

• Patients with gastrointestinal surgery or enterectomy
• Severe cardiac disease patients
• Patients with severe constipation or diarrhea
• Patients with a 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)

---

248 participants in 1 patient group

1. ASP1585

Experimental group

Treatment:

Drug: ASP1585