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Recently added Catalysts

sevelamer carbonate sevelamer

Phase 3

Chronic Kidney Disease | Small molecule | Nephrology |Sanofi|Last Updated: Mar 18, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

sevelamer carbonate sevelamer · 1 trial · 1 indication

Phase 3 1
NCT00267514Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis PatientsChronic Kidney Disease
COMPLETED31 Analytics
PHASE3COMPLETED
Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients
Chronic Kidney DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Demonstrate the equivalence of sevelamer carbonate powder to sevelamer hydrochloride tablets dosed three times per day (TID) with meals on the control of serum phosphorus levels
Up to 13 weeks
Evaluate the safety and tolerability of sevelamer carbonate powder compared to sevelamer hydrochloride tablets dosed TID with meals
Up to 13 weeks

Secondary Endpoints

Compare the effects of sevelamer carbonate powder to sevelamer hydrochloride tablets when dosed three times a day with meals on: serum calcium-phosphorus product
Up to 13 weeks
serum lipid profile (total cholesterol, high density lipoprotein [HDL] and low density lipoprotein [LDL] and triglycerides)
Up to 13 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1OTHERsevelamer carbonate powder x 4 weeks then, sevelamer hydrochloride x 4 weeks
2OTHERsevelamer hydrochloride x 4 weeks then, sevelamer carbonate powder x 4 weeks

Interventions

NameTypeDescription
sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)DRUGsevelamer carbonate powder dosed TID with meals for four weeks followed by sevelamer hydrochloride tablets dosed TID with meals for four weeks
sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)DRUGsevelamer hydrochloride tablets dosed TID with meals for four weeks followed by sevelamer carbonate powder dosed TID with meals for four weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Receiving three times per week haemodialysis for three months or longer. * Taking sevelamer hydrochloride alone (e.g. not using other types of phosphate binders concomitantly) or on combination therapy (e.g. using sevelamer hydrochloride and calcium containing, or metal phosph...

Countries:United Kingdom
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