Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

Completed · Phase 2

Conditions studied: Chronic Kidney Disease

In brief

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

Key facts

Study ID

NCT00440648

Run by

Genzyme, a Sanofi Company

People needed

80

Starts

2005-03-01

Expected to finish

2006-07-01

Last updated by the study team

2014-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Riverside, California, United States
• Study site — Greenwood Village, Colorado, United States
• Study site — Berwyn, Illinois, United States
• Study site — Crestwood, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Valparaiso, Indiana, United States
• Study site — Columbus, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Easton, Pennsylvania, United States
• Study site — Wynnewood, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.