Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients

A Double-blind, Randomized, Placebo-controlled Multi-center Trial to Compare the Phosphate Lowering Efficacy of Different Doses of SBR759 to Placebo

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01069692

Acronym

SBR759

Enrollment

115

Registered

2010-02-17

Start date

2010-02-28

Completion date

Unknown

Last updated

2020-12-19

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

Conditions

Chronic Kidney Disease, Hyperphosphatemia

Keywords

Chronic Kidney Disease, Hemodialysis, Hyperphosphatemia, Hyperphosphatemia patients with chronic kidney disease on 3x/week hemodialysis

Brief summary

This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.

Interventions

DRUGSBR759A

SBR759A 6g daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Men or women of at least 18 years of age 2. Stable maintenance of hemodialysis 3 times per week for 3 months or greater 3. Controlled serum phosphate if under phosphate-binder therapy 4. Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening

Exclusion criteria

1. Patients who are on peritoneal dialysis 2. Patients who have a transplant or parathyroidectomy scheduled during the study 3. Clinically significant GI disorder 4. Unstable medical condition other than Chronic Kidney Disease 5. Patient is currently being treated with oral iron 6. History of hemachromatosis, or ferritin \> 1000 ng/mL 7. Transferrin saturation \> 60% 8. Uncontrolled hyperparathyroidism (iPTH \> 84.8 pmol/L) Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment	6 weeks

Secondary

Measure	Time frame
Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment	6 weeks
Evaluate dose-dependent efficacy of SBR759	6 weeks
Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo	6 weeks

Countries

Belgium, Italy

Outcome results

None listed

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