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

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220593

Enrollment

200

Registered

2008-08-26

Start date

2008-08-26

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Chronic Kidney Disease

Interventions

investigational material(s) Generic name etc : SBR759 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigation

Eligibility

Sex/Gender

All

Inclusion criteria

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 ug/L. - Clinically significant GI disorder. - Unstable medical condition other than Chronic Kidney Disease. - Treated with sevelamer HCl monotherapy or SBR759. - Treated with oral iron.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Primary Outcome Measures: - Responder rates achieving target serum phosphate levels at 12 weeks. Secondary Outcome Measures: - Responder rates in target patients with serum calcium-phosphate levels at 12 weeks	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026