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Fosrenol

Phase 3

Hyperphosphatemia | Small molecule | Nephrology |Bayer AG|Last Updated: Apr 3, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment266

FDA Designations

No designations recorded

Clinical trial landscape

Fosrenol · 2 trials · 1 indication

Phase 3 2
NCT01187628Long-term Study in Chronic Kidney Disease (Extension From Study 14817)Hyperphosphatemia
COMPLETED123 Analytics
NCT01110629Study in Chronic Kidney Disease (CKD) Not on DialysisHyperphosphatemia
COMPLETED143 Analytics
PHASE3COMPLETED
Long-term Study in Chronic Kidney Disease (Extension From Study 14817)
Hyperphosphatemia
NCT01187628123
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PHASE3COMPLETED
Study in Chronic Kidney Disease (CKD) Not on Dialysis
Hyperphosphatemia
NCT01110629143
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Study Endpoints

Primary Endpoints

Incidence of treatment emergent adverse events
baseline to Week 60
The change from baseline in serum phosphate concentrations
Week 8

Secondary Endpoints

Achievement of target serum phosphate level (2.7 to 4.6 mg/dL)
Week 0, Week 2, Week 4, Week 6, Week 8
Change in serum Calcium x Phosphor product
Week 0, Week 2, Week 4, Week 6, Week 8
Serum intact PTH level
Week 0, Week 2, Week 4, Week 6, Week 8
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Fosrenol (Lanthanum Carbonate, BAY77-1931)DRUGDaily dose: 750-2250mg/day,(270-750mg each 3 times a day) for 52 weeks.
PlaceboDRUGdaily dose: 3 tablets TID for 8 weeks.
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * Patients who have completed the 8-week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study by the investigator (including those who plan to be on dialysis during the long-term extension study). Exclusion Criteria: * Pa...

Countries:Japan
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Frequently asked questions about Fosrenol

What is Fosrenol used for?

Fosrenol is used for hyperphosphatemia, a condition of elevated phosphate levels in the blood, in patients with chronic kidney disease (CKD) who are not on dialysis. It is an investigational small molecule being developed by Bayer AG.

What does Fosrenol target?

Fosrenol is a small molecule that targets phosphate binding in the gastrointestinal tract, reducing dietary phosphate absorption. It is being studied for hyperphosphatemia in chronic kidney disease patients not on dialysis.

Who makes Fosrenol?

Fosrenol is being developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is currently in Phase 3 clinical development for hyperphosphatemia.

What phase is Fosrenol in?

Fosrenol is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed in Japan for hyperphosphatemia in chronic kidney disease patients.

What clinical trials is Fosrenol in?

Fosrenol has two completed Phase 3 trials: NCT01110629, a study in chronic kidney disease not on dialysis with 143 participants, and NCT01187628, a long-term extension study with 123 participants. Both were conducted in Japan and enrolled adults aged 20 years and older.

Is Fosrenol the same as lanthanum carbonate?

Fosrenol is the brand name for lanthanum carbonate, a phosphate binder. It is being studied for hyperphosphatemia in chronic kidney disease patients not on dialysis. The drug is in Phase 3 development by Bayer AG.