Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis (LEAP)

Genzyme

Status and phase: Completed; Phase 2

Conditions: Kidney Failure, Chronic

Treatments: Drug: Placebo; Drug: Sevelamer carbonate; Drug: Genz-644470

Study type: Interventional

Funder types: Industry

Identifiers

NCT00853242

APB00108

Details and patient eligibility

About

The purpose of this clinical study is to compare the effects of Genz-644470 with the effects of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in hyperphosphatemic chronic kidney disease participants on hemodialysis.

Enrollment: 349 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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349 participants in 7 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.

Treatment:

Drug: Placebo

Genz-644470 2.4 Grams Per Day (g/day)

Experimental group

Description:

Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.

Treatment:

Drug: Genz-644470

Genz-644470 4.8 g/day

Experimental group

Description:

Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.

Treatment:

Drug: Genz-644470

Genz-644470 7.2 g/day

Experimental group

Description:

Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.

Treatment:

Drug: Genz-644470

Sevelamer Carbonate 2.4 g/day

Active Comparator group

Description:

Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.

Treatment:

Drug: Sevelamer carbonate

Sevelamer Carbonate 4.8 g/day

Active Comparator group

Description:

Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.

Treatment:

Drug: Sevelamer carbonate

Sevelamer Carbonate 7.2 g/day

Active Comparator group

Description:

Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.

Treatment:

Drug: Sevelamer carbonate