Overview

Sevelamer Hydrochloride and Femoral and Carotid Intima Media Thickness Progression in End Stage Renal Disease

Status:
Completed

Trial end date:
2009-02-01

Target enrollment:
0

Participant gender:
All

Summary

Aims of the multi-center, randomized, treatment-controlled clinical trial are to compare the efficacy of sevelamer hydrochloride to calcium-containing phosphorus binders in reducing the rate of progression of femoral and carotid intimal media thickness (IMT) thickening as measured by B-mode ultrasound in stable maintenance hemodialysis (HD) patients.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Tel-Aviv Sourasky Medical Center

Collaborators:

Genzyme, a Sanofi Company
Wolfson Medical Center

Treatments:

Calcium
Calcium Carbonate
Sevelamer

Criteria

Inclusion Criteria:

- HD Patients aged 40-75 years inclusive if they received HD treatment three times each
week for not less than three months, and if they had not been treated with sevelamer
hydrochloride. Patients of both genders, without regard to diabetes status, history of
CVD or underlying renal disease were eligible.

Exclusion Criteria:

- Patients receiving treatment with sevelamer hydrochloride were not eligible for study
participation. Additionally, patients were excluded if they had active liver disease,
known sensitivity to either sevelamer hydrochloride or calcum carbonate or if their
participation in the study was deemed in any way detrimental or unwarranted by the
patient's treating physician.