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SBR759

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment263

FDA Designations

No designations recorded

Clinical trial landscape

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 these patient populations.

Who makes SBR759?

SBR759 is being developed by Novartis AG (NVS). The company has conducted clinical trials evaluating the drug's efficacy in lowering serum phosphate levels in chronic kidney disease patients on hemodialysis.

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 been studied in two completed Phase 2 trials: NCT00704483, which enrolled 321 patients with hyperphosphatemia on 3x/week replacement therapy, and NCT00704678, which enrolled 203 Asian chronic kidney disease patients on hemodialysis. A Phase 1 trial, NCT00750295, enrolled 60 patients.

How does SBR759 work?

SBR759 is a phosphate binder. It works by binding to phosphate in the gastrointestinal tract, reducing its absorption and thereby lowering serum phosphate levels in patients with chronic kidney disease.