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

NCT01049815 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2010-01-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

sevelamer hydrochloride

800-3200 mg with each meal

DRUG

Calcium Carbonate

600 mg with each meal, up to 1800 mg a day

Sponsors & Collaborators

  • Wolfson Medical Center

    collaborator OTHER_GOV

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Talia Weinstein, MD PhD · Tel Aviv Medical Center

  • Mona Boaz, PhD · Edith Wolfson Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01049815 on ClinicalTrials.gov