Clinical trial NCT00324376: Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
Official title: A Randomized, Cross-Over Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-05-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. Following a two week Run-In period, a total of 24 patients will be randomized to one of the following treatment sequences:

1. sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals
2. sevelamer dosed three times per day with meals followed by once a day dosing with the largest meal. Patients will maintain a fixed daily dose throughout both treatment periods based on the most recently prescribed sevelamer dose prior to screening.


Eligibility criteria: Inclusion Criteria:

* life expectancy of at least 12 months,
* patients have received hemodialysis three times per week for 3 months or longer,
* patients maintained on sevelamer in a daily dose of ≤ 9,600 mg as their only phosphate binder with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL (0.97 and 2.10 mmol/L).

Exclusion Criteria:

* active bowel obstruction,
* dysphagia,
* swallowing disorders,
* 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,
* any clinically significant unstable medical condition as judged by the investigator.

Primary outcomes:
measure: Treatment compared on basis of serum phosphorus at end of each treatment and calcium corrected for albumin,calcium-phosphorus product,albumin,iPTH,total,LDL,HDL,non-HDL cholesterol,triglycerides. Safety evaluated on AEs;change in lab values.
Secondary outcomes:
Other outcomes:
Locations:
city: Olympia Fields
country: United States
facility: Renal Care Group
state: Illinois
city: Cincinnati
country: United States
facility: Kidney and Hypertension Center
state: Ohio
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Fishbane S, Delmez J, Suki WN, Hariachar SK, Heaton J, Chasan-Taber S, Plone MA, Moe S. A randomized, parallel, open-label study to compare once-daily sevelamer carbonate powder dosing with thrice-daily sevelamer hydrochloride tablet dosing in CKD patients on hemodialysis. Am J Kidney Dis. 2010 Feb;55(2):307-15. doi: 10.1053/j.ajkd.2009.10.051. Epub 2009 Dec 30.