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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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End Stage Renal Disease, Hemodialysis, Intimal Media Thickness

Intervention / Treatment
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* Drug: sevelamer hydrochloride
* Drug: Calcium Carbonate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sevelamer hydrochloride<br> | Drug: sevelamer hydrochloride<br>* 800-3200 mg with each meal<br>* Other names: Renagel;|
| Active Comparator: Calcium carbonate<br> | Drug: Calcium Carbonate<br>* 600 mg with each meal, up to 1800 mg a day<br>* Other names: Caltrate, Calcimor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in carotid and femoral IMT as measured using B-mode ultrasonography |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, intimal media thickness