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SBR759

Phase 2

Chronic Kidney Disease | Small molecule | Nephrology |Novartis AG|Trials Updated: Dec 19, 2020

SBR759 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Jun 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials3
Total Enrollment584

FDA Designations

No designations recorded

SBR759 clinical trials

SBR759 · 3 trials · 2 indications

Phase 2 2Phase 1 1
NCT00704678Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on HemodialysisChronic Kidney Disease
COMPLETED203 Analytics
NCT00704483Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on HemodialysisHyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy
COMPLETED321 Analytics
PHASE2COMPLETED
Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis
Chronic Kidney DiseaseUnlock trial analytics
PHASE2COMPLETED
Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement TherapyUnlock trial analytics

Study Endpoints

Primary Endpoints

Responder rates achieving target serum phosphate levels.
Week 12
Responder rates in target serum phosphate levels at 12 weeks Evaluate efficacy of SBR759 compared to sevelamer HCl at 12 weeks
Time Frame: 12 weeks + 12 months
In addition to the standard safety assessments (vital signs, ECGs, clinical chemistry and adverse events), serum phosphorus concentration is frequently measured during the study.

Secondary Endpoints

Responder rates in target patients with serum calcium-phosphate levels.
Week 12
Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months
Time Frame: 12 weeks / 12 months
Several biomarkers and patient-reported outcomes are assessed at specified time points, before and after treating patients with the study drug.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL1g bid
2ACTIVE_COMPARATOR0.8 g tid
3EXPERIMENTAL1.5 g tid
4ACTIVE_COMPARATOR1.6 g tid
5EXPERIMENTAL -
6EXPERIMENTAL -
7EXPERIMENTAL -

Interventions

NameTypeDescription
SBR759DRUG1g tid
Sevelamer HClDRUG1.6 g tid
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

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. Excl...

Countries:JapanTaiwanUnited StatesAustraliaBelgiumCanadaFinlandFranceGermanyItalyNorwayPuerto RicoSwedenSwitzerlandUnited Kingdom
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Frequently asked questions about SBR759

What is SBR759 used for?

SBR759 is an investigational small molecule being developed for hyperphosphatemia in patients with chronic kidney disease on 3x/week replacement therapy, and for chronic kidney disease. It is designed to lower serum phosphate levels in patients on hemodialysis.

Who makes SBR759?

SBR759 is being developed by Novartis AG, traded on the New York Stock Exchange under the ticker NVS. The company has sponsored clinical trials evaluating the drug in chronic kidney disease patients with hyperphosphatemia.

What phase is SBR759 in?

SBR759 is in Phase 2 clinical development. Two Phase 2 trials have been completed, along with one Phase 1 trial. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is SBR759 in?

SBR759 has completed two Phase 2 trials: NCT00704483 in 321 patients across multiple countries, and NCT00704678 in 203 patients in Japan and Taiwan. A Phase 1 trial, NCT00750295, enrolled 60 patients in the United States.

How does SBR759 work?

SBR759 is a phosphate binder designed to lower serum phosphate levels in chronic kidney disease patients on hemodialysis. By binding phosphate in the gastrointestinal tract, it reduces phosphate absorption and helps control hyperphosphatemia.

Is SBR759 the same as other phosphate binders?

SBR759 is a distinct investigational phosphate binder developed by Novartis. It is not the same as other marketed phosphate binders, and no alternative names for SBR759 have been reported in clinical trial records.