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Fosrenol

Phase 3

Chronic Kidney Disease, Stage 5 | Small molecule | Nephrology |Takeda Pharmaceutical Company Limited|Last Updated: Jun 11, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment182

FDA Designations

No designations recorded

Clinical trial landscape

Fosrenol · 1 trial · 1 indication

Phase 3 1
NCT00441545Head to Head Study Against Sevelamer HydrochlorideChronic Kidney Disease, Stage 5
COMPLETED182 Analytics
PHASE3COMPLETED
Head to Head Study Against Sevelamer Hydrochloride
Chronic Kidney Disease, Stage 5Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Serum Phosphorus Levels at 4 Weeks
4 weeks

Secondary Endpoints

Change From Baseline in Serum Calcium Levels at 4 Weeks
4 weeks
Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks
Baseline and 4 weeks
Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks
4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALFosrenol (Lanthanum carbonate)
2ACTIVE_COMPARATORSevelamer hydrochloride

Interventions

NameTypeDescription
Fosrenol (Lanthanum Carbonate)DRUGThe starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.
Sevelamer hydrochlorideDRUGThe starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: * Adults with end stage renal disease who are receiving dialysis Exclusion Criteria: * Subjects with significant gastrointestinal disorders * Subjects who are pregnant or nursing * Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride...

Countries:United StatesGermanyPuerto RicoUnited Kingdom
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Frequently asked questions about Fosrenol

What is Fosrenol used for?

Fosrenol is a small molecule drug being developed for chronic kidney disease, stage 5. It is currently in Phase 3 clinical development and is being studied in patients with this condition.

Who makes Fosrenol?

Fosrenol is being developed by Takeda Pharmaceutical Company Limited, which is publicly traded under the ticker TAK.

What phase is Fosrenol in?

Fosrenol is in Phase 3 clinical development. It is an investigational drug and has not been approved for use.

What clinical trials is Fosrenol in?

Fosrenol has one completed Phase 3 clinical trial, identified as NCT00441545. This trial was a head-to-head study against sevelamer hydrochloride and enrolled 182 participants with chronic kidney disease, stage 5.

Is Fosrenol the same as sevelamer hydrochloride?

No, Fosrenol is not the same as sevelamer hydrochloride. In clinical trial NCT00441545, Fosrenol was studied head-to-head against sevelamer hydrochloride as an active control.