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Genz-644470

Phase 2

Kidney Failure, Chronic | Small molecule | Nephrology |Sanofi|Last Updated: May 1, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment349

FDA Designations

No designations recorded

Clinical trial landscape

Genz-644470 · 1 trial · 1 indication

Phase 2 1
NCT00853242Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on HemodialysisKidney Failure, Chronic
COMPLETED349 Analytics
PHASE2COMPLETED
Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
Kidney Failure, ChronicUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)
Baseline, Day 22

Secondary Endpoints

Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)
Baseline, Day 22
Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22
Baseline, Day 22
Change From Baseline in Total Cholesterol at Day 22
Baseline, Day 22
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
Genz-644470 2.4 Grams Per Day (g/day)EXPERIMENTALGenz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470 4.8 g/dayEXPERIMENTALGenz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470 7.2 g/dayEXPERIMENTALGenz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 2.4 g/dayACTIVE_COMPARATORSevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 4.8 g/dayACTIVE_COMPARATORSevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 7.2 g/dayACTIVE_COMPARATORSevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.

Interventions

NameTypeDescription
PlaceboDRUG -
Genz-644470DRUG -
Sevelamer carbonateDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites53

Inclusion Criteria: * Serum phosphate level greater than (\>) 5.5 milligram per deciliter (mg/dL) (1.78 millimole per liter \[mmol/L\]) after discontinuation of current phosphate binder therapy * Men or women 18 years or older Exclusion Criteria: * Have active dysphagia or swallowing disorder or ...

Countries:United StatesPuerto Rico
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Frequently asked questions about Genz-644470

What is Genz-644470 used for?

Genz-644470 is an investigational small molecule being studied for the treatment of chronic kidney failure. It was evaluated in a Phase 2 clinical trial in patients with chronic kidney disease on hemodialysis. The drug is not approved and remains in clinical development.

Who makes Genz-644470?

Genz-644470 is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. The drug is an investigational small molecule in Phase 2 clinical development for chronic kidney failure.

What phase is Genz-644470 in?

Genz-644470 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Genz-644470 in?

Genz-644470 has one completed clinical trial, identified as NCT00853242. This Phase 2 study compared Genz-644470, placebo, and sevelamer carbonate in chronic kidney disease patients on hemodialysis. The trial enrolled 349 participants in the United States and Puerto Rico.

How does Genz-644470 work?

Genz-644470 is a small molecule, but its specific molecular target has not been disclosed. In a Phase 2 trial, it was compared against sevelamer carbonate, a phosphate binder, in chronic kidney disease patients on hemodialysis, suggesting it may affect phosphate metabolism, though this is not confirmed.