Full Text View
Tabular View
No Study Results Posted
Related Studies
Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate
This study has been completed.
Study NCT00440648   Information provided by Genzyme
First Received: February 24, 2007   Last Updated: July 29, 2009   History of Changes

February 24, 2007
July 29, 2009
March 2005
March 2006   (final data collection date for primary outcome measure)
  • Safety-evaluated on the basis of adverse events (reported and/or observed) [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • changes in laboratory parameters, vital signs [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • note: clinically significant changes in physical examination were recorded and evaluated as adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Safety-evaluated on the basis of adverse events (reported and/or observed)
  • changes in laboratory parameters, vital signs
  • note: clinically significant changes in physical examination were recorded and evaluated as adverse events
  • 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
  • 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.
Complete list of historical versions of study NCT00440648 on ClinicalTrials.gov Archive Site
 
 
 
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

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

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.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
Chronic Kidney Disease
  • Drug: sevelamer carbonate, sevelamer hydrochloride
  • Drug: sevelamer hydrochloride, sevelamer carbonate
  • Other: sevelamer carbonate w(1-8) sevelamer hydrochloride w(9-16)
  • Other: sevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
80
July 2006
March 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00440648
Medical Monitor, Genzyme Corporation
GD3-163-201
Genzyme
 
Study Director: Medical Monitor Genzyme
Genzyme
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP