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

Astellas Pharma Inc163 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

163

Conditions

Chronic Kidney Disease Renal Insufficiency Hyperphosphatemia

Interventions

ASP1585DRUG

oral

placeboDRUG

oral

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (5)

Unnamed facility

Chūbu, Japan

Unnamed facility

Hokkaido, Japan

Unnamed facility

Kansai, Japan

Unnamed facility

Kanto, Japan

Unnamed facility

Kyushu, Japan

Outcomes

Primary Outcomes

Change from baseline in serum phosphorus level at the end of treatment

Time frame: Baseline and Week 12 or treatment discontinuation