A Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal Dialysis

Astellas

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease; Renal Insufficiency; Renal Dialysis

Treatments: Drug: ASP1585

Study type: Interventional

Funder types: Industry

Identifiers

NCT01017276

1585-CL-0005

Details and patient eligibility

About

This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 in chronic kidney disease and hyperphosphatemia patients on peritoneal dialysis.

Enrollment: 35 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic kidney disease patients on peritoneal dialysis
• Hyperphosphatemia
• Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not 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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

ASP group

Experimental group

Treatment:

Drug: ASP1585