Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis

A 12-week, Open Label, Multicenter, Titration Study, With a 12 Month Extension, to Determine the Optimal Titration Regimen for SBR759, Compared to Sevelamer HCl, in Lowering Serum Phosphate Levels in Asian Patients With Chronic Kidney Disease on Hemodialysis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00704678

Acronym

SBR759

Enrollment

203

Registered

2008-06-25

Start date

2008-08-31

Completion date

Unknown

Last updated

2016-09-23

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

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease, hemodialysis, hyperphosphatemia, Asian, patients

Brief summary

This study will determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis

Interventions

DRUGSBR759

1g tid

DRUGSevelamer HCl

1.6 g tid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Men or women of at least 18 years old or 20 years old in Japan. * Stable maintenance of hemodialysis 3 times per week. * Controlled serum phosphate if under phosphate-binder therapy. * Serum phosphate level \> 6.0 mg/dL (\> 1.9 mmol/L) prior to study treatment initiation.

Exclusion criteria

* Peritoneal dialysis or a non-conventional hemodialysis technique . * Parathyroidectomy or transplant scheduled during the study. * Uncontrolled hyperparathyroidism * History of hemochromatosis or ferritin \> 800 µg/L. * Clinically significant GI disorder * Unstable medical condition other than Chronic Kidney Disease. * Treated with sevelamer HCl monotherapy or SBR759. * Treated with oral iron. * Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Responder rates achieving target serum phosphate levels.	Week 12

Secondary

Measure	Time frame
Responder rates in target patients with serum calcium-phosphate levels.	Week 12

Countries

Japan, Taiwan

Outcome results

None listed

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