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CompletedNCT01049815SUMMERUpdated Jan 14, 2010

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

An interventional study of sevelamer hydrochloride and Calcium Carbonate in End Stage Renal Disease, Hemodialysis and Intimal Media Thickness, sponsored by Tel-Aviv Sourasky Medical Center. Completed at 2 sites in Israel. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-01-14.

Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
175
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • End Stage Renal Disease
  • Hemodialysis
  • Intimal Media Thickness

Keywords

  • hemodialysis
  • intimal media thickness
03

In context

Kidney Failure, Chronic

2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.

This study's enrollment of 175 is above the median of 55 across 1,582 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 552 studies on the registry; 49 are open to participants now.

Browse Tel-Aviv Sourasky Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
175 participants (actual)

Study arms

  • Experimental
    Sevelamer hydrochloride

    Drug: sevelamer hydrochloride

  • Active comparator
    Calcium carbonate

    Drug: Calcium Carbonate

Interventions

06

What researchers measure

Primary outcomes

  1. Increase in carotid and femoral IMT as measured using B-mode ultrasonography

    Time frame: 1 year

Secondary outcomes

  1. 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

07

Study locations

2 sites
  • Edith Wolfson Medical Center
    Holon, Israel
  • Tel Aviv Medical Center
    Tel Aviv, Israel
08

References and documents

Publications

  • Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4. PubMed 40576086 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2005, a primary completion of Feb 2009 and a completion of Feb 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 13, 2010
First posted
Jan 14, 2010
Start
Feb 2005
Primary completionActual
Feb 2009
CompletionActual
Feb 2009
Last update
Jan 14, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 14, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01049815
Lead sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Wolfson Medical Center, Genzyme, a Sanofi Company
First posted
Jan 14, 2010
Start date
Feb 2005
Primary completion
Feb 2009
Completion
Feb 2009
Last update
Jan 14, 2010

Study contacts

Talia Weinstein, MD PhD
principal investigator · Tel Aviv Medical Center
Mona Boaz, PhD
principal investigator · Edith Wolfson Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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