NCT01049815

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
Last Updated

January 14, 2010

Status Verified

January 1, 2010

Enrollment Period

4 years

First QC Date

January 13, 2010

Last Update Submit

January 13, 2010

Conditions

End Stage Renal DiseaseHemodialysisIntimal Media Thickness

Keywords

hemodialysisintimal media thickness

Outcome Measures

Primary Outcomes (1)

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

    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 .

    1 year

Study Arms (2)

Sevelamer hydrochloride

EXPERIMENTAL
Drug: sevelamer hydrochloride

Calcium carbonate

ACTIVE COMPARATOR
Drug: Calcium Carbonate

Interventions

sevelamer hydrochlorideDRUG

800-3200 mg with each meal

Also known as: Renagel
Sevelamer hydrochloride
Calcium CarbonateDRUG

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

Also known as: Caltrate, Calcimor
Calcium carbonate

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Edith Wolfson Medical Center

Holon, Israel

Location

Tel Aviv Medical Center

Tel Aviv, Israel

Location

Related Publications (1)

  • 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.

    PMID: 40576086DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

SevelamerCalcium Carbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic ChemicalsCalcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Talia Weinstein, MD PhD

    Tel Aviv Medical Center

    PRINCIPAL INVESTIGATOR

  • Mona Boaz, PhD

    Edith Wolfson Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 14, 2010

Study Start

February 1, 2005

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

January 14, 2010

Record last verified: 2010-01

Locations

IL(2)