Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate
A Double-Blind, Cross-Over Design Study of Sevelamer Hydrochloride (Renagel®) and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
1 other identifier
interventional
80
1 country
15
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2005
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 24, 2007
CompletedFirst Posted
Study publicly available on registry
February 27, 2007
CompletedMarch 19, 2014
March 1, 2014
1 year
February 24, 2007
March 17, 2014
Conditions
Outcome Measures
Primary Outcomes (5)
Safety-evaluated on the basis of adverse events (reported and/or observed)
16 weeks
changes in laboratory parameters, vital signs
16 weeks
note: clinically significant changes in physical examination were recorded and evaluated as adverse events
16 weeks
Efficacy-treatment regimens are compared on the basis of serum phosphorus at the end of each treatment period using the time-weighted mean of the phosphorus value from the last three visits in each treatment period
16 weeks
Treatment regimens were also compared with respect to total, LDL, and HDL cholesterol, and triglycerides, using the mean of values for each parameter from the two post-baseline assessments in each treatment period.
16 weeks
Study Arms (2)
1
OTHERsevelamer carbonate w(1-8) sevelamer hydrochloride w(9-16)
2
OTHERsevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16)
Interventions
Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Riverside, California, 92501, United States
Unknown Facility
Greenwood Village, Colorado, 80111, United States
Unknown Facility
Berwyn, Illinois, 60402, United States
Unknown Facility
Crestwood, Illinois, 60445, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Valparaiso, Indiana, 46383, United States
Unknown Facility
Columbus, Missouri, 39705, United States
Unknown Facility
St Louis, Missouri, 63103, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Winston-Salem, North Carolina, 27157, United States
Unknown Facility
Easton, Pennsylvania, 19045, United States
Unknown Facility
Wynnewood, Pennsylvania, 19096, United States
Unknown Facility
Nashville, Tennessee, 37205, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 24, 2007
First Posted
February 27, 2007
Study Start
March 1, 2005
Primary Completion
March 1, 2006
Study Completion
July 1, 2006
Last Updated
March 19, 2014
Record last verified: 2014-03