A Comparative Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis

A Phase 3, Multicenter, Open-label, Sevelamer Hydrochloride-controlled Study in Chronic Kidney Disease (CKD) Patients With Hyperphosphatemia on Hemodialysis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01057407

Enrollment

110

Registered

2010-01-27

Start date

2010-01-31

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, Renal Dialysis, Renal Insufficiency

Keywords

Hyperphosphatemia, hemodialysis, CKD, ASP1585

Brief summary

This is a multi-center, open-labeled study to examine the non-inferiority of ASP1585 to sevelamer hydrochloride in chronic kidney disease patients with hyperphosphatemia on hemodialysis.

Interventions

DRUGASP1585

oral

DRUGSevelamer hydrochloride

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

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 * Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not been 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

Design outcomes

Primary

Measure	Time frame
Serum phosphorus level at the end of treatment	After 12-week or at the treatment discontinuation

Secondary

Measure	Time frame
Change in serum phosphorus level	After 12-week or at the end of treatment
Time-course changes in serum phosphorus levels	During Treatment
Changes in serum Ca x P	During treatment
Changes in intact PTH levels	During Treatment

Countries

Japan

Outcome results

None listed

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