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

End Stage Renal Disease Clinical Trial

— SUMMER  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049815
• Other study ID #: 04-285
• Status: Completed
• Phase: N/A
• First received: January 13, 2010
• Last updated: January 13, 2010
• Start date: February 2005
• Est. completion date: February 2009

Study information

• Verified date: January 2010
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodialysis
• Intimal Media Thickness
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
Israel	Edith Wolfson Medical Center	Holon
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (3)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Genzyme, a Sanofi Company, Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in carotid and femoral IMT as measured using B-mode ultrasonography		1 year	No
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	No