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

Overview

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.

Full Title of Study: “A Randomized-controlled Trial Comparing the Efficacy of Two Phosphorous Binders, Renagel and Caltrate in Reducing the Rate of Progression of Femoral and Carotid IMT Thickening as Measured by B-mode Ultrasound in Dialysis Patients.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2009

Detailed Description

Serum phosphorus (P) is frequently elevated in HD patients. Serum P stimulates PTH synthesis and is associated with secondary hyperparathyroidism. Use of calcium(Ca)-containing phosphorus-binders is an exogenous source of Ca that can elevate the CaxP product. In HD patients, an ultrasonographically-demonstrated increase in intima media thickness of the carotid artery has been associated with elevated serum P levels.Peripheral arterial vascular disease (PVD) accounts for significant mortality and morbidity in HD patients.

The aim of this study is 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 HD patients.

Subject randomization numbers was provided by the Epidemiology and Research Unit, E. Wolfson Medical Center, Holon, Israel. After meeting all inclusion criteria, subjects were randomized to one of two treatment groups: Renagel or calcium carbonate. Prior to receiving treatment, baseline femoral and carotid IMT were measured, medical and pharmaceutical history was documented, nutrition assessment was undertaken and midweek blood chemistry and blood count were measured. No change in patient medication prescription was required during this study, with the exception of phosphorus binders. All other concomitant medications were continued. During the year of the study, routine monthly blood tests were obtained for chemistry, blood count, and PTH was measured once every 4 months.

After a year of treatment, femoral and carotid IMT were measured again, midweek blood chemistry and blood count were measured.

Interventions

  • Drug: sevelamer hydrochloride
    • 800-3200 mg with each meal
  • Drug: Calcium Carbonate
    • 600 mg with each meal, up to 1800 mg a day

Arms, Groups and Cohorts

  • Experimental: Sevelamer hydrochloride
  • Active Comparator: Calcium carbonate

Clinical Trial Outcome Measures

Primary Measures

  • Increase in carotid and femoral IMT as measured using B-mode ultrasonography
    • Time Frame: 1 year

Secondary Measures

  • 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 .
    • Time Frame: 1 year

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tel-Aviv Sourasky Medical Center
  • Collaborator
    • Wolfson Medical Center
  • Provider of Information About this Clinical Study
    • Talia Weinstein MD PhD, Tel Aviv Medical Center
  • Overall Official(s)
    • Talia Weinstein, MD PhD, Principal Investigator, Tel Aviv Medical Center
    • Mona Boaz, PhD, Principal Investigator, Edith Wolfson Medical Center

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