Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

Genzyme

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Drug: sevelamer carbonate, sevelamer hydrochloride; Drug: sevelamer hydrochloride, sevelamer carbonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00440648

GD3-163-201

Details and patient eligibility

About

This is a double-blind, randomized, cross-over study conducted at centers within the United States. The study consists of five periods: an up to two-week Screening Period, a 5-week Run-In Period, two eight-week study treatment periods and a two-week Washout Period. Patients are assigned randomly (1:1) to one of two treatment sequences: sevelamer carbonate for eight weeks followed by sevelamer hydrochloride for eight weeks or sevelamer hydrochloride for eight weeks followed by sevelamer carbonate for eight weeks

Full description

The study was conducted at 15 centers (2 of which did not enroll any patients). A total of 79 hemodialysis patients were assigned randomly to one of two treatment sequences.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient had received hemodialysis three times per week for 3 months or longer;
• patients were maintained on sevelamer hydrochloride as their primary phosphate binder with a total daily dose of ≤ 13.6 g with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL, the most recent iPTH ≤ 600 pg/mL and the most recent serum calcium within the normal range.

Exclusion criteria

• if patient had active bowel obstruction, dysphagia, swallowing disorders, or severe gastrointestinal motility disorders;
• active ethanol or drug abuse (excluding tobacco);
• need for antidysrhythmic or antiseizure medications used to control these conditions;
• poorly controlled diabetes mellitus or hypertension;
• active vasculitis;
• active malignancy other than basal-cell carcinoma;
• HIV infection; or
• any clinically significant unstable medical condition as judge by the Investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

1

Other group

Description:

sevelamer carbonate w(1-8) sevelamer hydrochloride w(9-16)

Treatment:

Drug: sevelamer carbonate, sevelamer hydrochloride

2

Other group

Description:

sevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16)

Treatment:

Drug: sevelamer hydrochloride, sevelamer carbonate