Head to Head Study Against Sevelamer Hydrochloride

Shire

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease, Stage 5

Treatments: Drug: Sevelamer hydrochloride; Drug: Fosrenol (Lanthanum Carbonate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00441545

SPD405-319

2006-004959-38 (EudraCT Number)

Details and patient eligibility

About

To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Full description

To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Enrollment: 182 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Subjects who are HIV positive
• Subjects with clinical significant liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

1

Experimental group

Description:

Fosrenol (Lanthanum carbonate)

Treatment:

Drug: Fosrenol (Lanthanum Carbonate)

2

Active Comparator group

Description:

Sevelamer hydrochloride

Treatment:

Drug: Sevelamer hydrochloride