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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | sevelamer carbonate w(1-8) sevelamer hydrochloride w(9-16) |
|
| 2 | Other | sevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sevelamer carbonate, sevelamer hydrochloride | Drug | Starting dose individualized for each patient and fixed daily dose throughout both treatment periods |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36608 | United States | |||
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| sevelamer hydrochloride, sevelamer carbonate | Drug | Starting dose individualized for each patient and fixed daily dose throughout both treatment periods |
|
| Riverside |
| California |
| 92501 |
| United States |
| Greenwood Village | Colorado | 80111 | United States |
| Berwyn | Illinois | 60402 | United States |
| Crestwood | Illinois | 60445 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Valparaiso | Indiana | 46383 | United States |
| Columbus | Missouri | 39705 | United States |
| St Louis | Missouri | 63103 | United States |
| St Louis | Missouri | 63110 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Easton | Pennsylvania | 19045 | United States |
| Wynnewood | Pennsylvania | 19096 | United States |
| Nashville | Tennessee | 37205 | United States |
| Norfolk | Virginia | 23507 | United States |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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