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SBR759A

Phase 3

Hyperphosphatemia | Small molecule | Nephrology |Novartis AG|Last Updated: Dec 19, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment115

FDA Designations

No designations recorded

Clinical trial landscape

SBR759A · 1 trial · 2 indications

Phase 3 1
NCT01069692Placebo Versus SBR759 in Lowering Phosphate in Dialysis PatientsHyperphosphatemia
COMPLETED115 Analytics
PHASE3COMPLETED
Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients
Hyperphosphatemia
NCT01069692115
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1PLACEBO_COMPARATORPlacebo
Arm 3EXPERIMENTAL -
Arm 2EXPERIMENTAL -
arm 4EXPERIMENTALSBR759A
arm 5EXPERIMENTAL -

Interventions

NameTypeDescription
SBR759ADRUGSBR759A 6g daily
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

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 ph...

Countries:BelgiumItaly
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Frequently asked questions about SBR759A

What is SBR759A used for?

SBR759A is an investigational small molecule being developed for hyperphosphatemia, a condition of elevated phosphate levels in the blood, in patients with chronic kidney disease. It is intended to lower phosphate levels in dialysis patients. The drug is currently in Phase 3 clinical development.

What does SBR759A target?

SBR759A is a small molecule that targets phosphate in the body. It is designed to lower phosphate levels in patients with hyperphosphatemia, particularly those undergoing dialysis for chronic kidney disease. The drug works by binding to phosphate in the gastrointestinal tract, reducing its absorption.

Who makes SBR759A?

SBR759A is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of SBR759A for the treatment of hyperphosphatemia in dialysis patients.

What phase is SBR759A in?

SBR759A is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial, which has been completed, was designed to evaluate the drug's ability to lower phosphate levels in dialysis patients with hyperphosphatemia.

What clinical trials is SBR759A in?

SBR759A has one completed Phase 3 clinical trial, identified by the National Clinical Trial number NCT01069692. This trial, titled 'Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients,' enrolled 115 participants with hyperphosphatemia and chronic kidney disease. The study was conducted in Belgium and Italy.

Is SBR759A the same as SBR759?

SBR759A is the drug name used in the clinical trial data, while SBR759 is an alternative name for the same compound. Both names refer to the same investigational small molecule being developed by Novartis for hyperphosphatemia. The Phase 3 trial NCT01069692 used the name SBR759 in its title.