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

A Phase 3, Long-term Study in Patients With Chronic Kidney Disease (CKD) and Hyperphosphatemia on Hemodialysis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00892749

Enrollment

248

Registered

2009-05-04

Start date

2009-05-31

Completion date

2010-09-30

Last updated

2015-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Hyperphosphatemia, Renal Dialysis, Renal Insufficiency

Keywords

hyperphosphatemia, hemodialysis, CKD, ASP1585

Brief 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 and hyperphosphatemia patients on hemodialysis.

Interventions

DRUGASP1585

oral

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Changes in serum Phosphorus level	After 48 weeks

Secondary

Measure	Time frame
Percent of the patients meeting the target range of serum Phosphorus levels	During the treatment
Changes in serum Calcium level	After 48 weeks
Changes in serum Ca x P	After 48 weeks
Changes in intact PTH level	After 48 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026