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

Astellas Pharma Inc248 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

248

Conditions

Chronic Kidney Disease Renal Dialysis Renal Insufficiency Hyperphosphatemia

Interventions

ASP1585DRUG

oral

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (4)

Unnamed facility

Chugoku, Japan

Unnamed facility

Chūbu, Japan

Unnamed facility

Kansai, Japan

Unnamed facility

Kantou, Japan

Outcomes

Primary Outcomes

Changes in serum Phosphorus level

Time frame: After 48 weeks

Secondary Outcomes

Percent of the patients meeting the target range of serum Phosphorus levels

Time frame: During the treatment

Changes in serum Calcium level

Time frame: After 48 weeks

Changes in serum Ca x P

Time frame: After 48 weeks

Changes in intact PTH level

Time frame: After 48 weeks

Data from ClinicalTrials.gov

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