| 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 ]
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- 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.
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| Complete list of historical versions of study NCT00440648 on ClinicalTrials.gov Archive Site |
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| 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
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- Other: sevelamer carbonate w(1-8) sevelamer hydrochloride w(9-16)
- Other: sevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16)
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| 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.
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
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| NCT00440648 |
| Medical Monitor, Genzyme Corporation |
| GD3-163-201 |
| Genzyme |
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| Study Director: |
Medical Monitor |
Genzyme |
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| Genzyme |
| February 2007 |