| Trial ID: | L1451 |
| Source ID: | NCT01049815
|
| Associated Drug: |
Sevelamer Hydrochloride
|
| Title: |
Sevelamer Hydrochloride and Femoral and Carotid Intima Media Thickness Progression in End Stage Renal Disease
|
| Acronym: |
SUMMER
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease|Hemodialysis|Intimal Media Thickness
|
| Interventions: |
DRUG: sevelamer hydrochloride|DRUG: Calcium Carbonate
|
| Outcome Measures: |
Primary: Increase in carotid and femoral IMT as measured using B-mode ultrasonography, 1 year | Secondary: Clinically evident PVD in a previously unaffected limb confirmed by doppler or duplex ultrasonography. Also, serum P, serum Ca, PTH and % of treatment group compliant with the revised treatment goals ., 1 year
|
| Sponsor/Collaborators: |
Sponsor: Tel-Aviv Sourasky Medical Center | Collaborators: Wolfson Medical Center|Genzyme, a Sanofi Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
175
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2005-02
|
| Completion Date: |
2009-02
|
| Results First Posted: |
|
| Last Update Posted: |
2010-01-14
|
| Locations: |
Edith Wolfson Medical Center, Holon, Israel|Tel Aviv Medical Center, Tel Aviv, Israel
|
| URL: |
https://clinicaltrials.gov/show/NCT01049815
|
