NCT00486772

Brief Summary

Vascular calcification and endothelial dysfunction (ED) contribute to the development of cardiovascular disease (CVD) in patients with chronic kidney disease (CKD). Sevelamer, a non-calcium based phosphate binder, has been shown to attenuate cardiovascular calcification in CKD patients while the exact mechanism has not been clarified. This study was designed to investigate the effect of short-term sevelamer treatment on both serum fetuin-A concentrations and ED seen in CKD patients.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2007

Completed
Last Updated

June 19, 2007

Status Verified

June 1, 2007

First QC Date

June 13, 2007

Last Update Submit

June 18, 2007

Conditions

Vascular Diseases

Keywords

This study was designed to investigate whether the suggested beneficial effects of sevelamer on VC were related to fetuin-A levels in patients with CKD.

Interventions

Sevelamer (Renagel), calcium acetate (Phos-ex)DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CKD stage 4 patients
  • Older than 18 years of age
  • Non-diabetic
  • Serum phosphorus \> 5.5 mg/dl

You may not qualify if:

  • Diabetes mellitus
  • History of coronary artery disease
  • Smokers
  • Taking statins or renin-angiotensin blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Caglar K, Yilmaz MI, Saglam M, Cakir E, Acikel C, Eyileten T, Yenicesu M, Oguz Y, Vural A, Carrero JJ, Axelsson J, Lindholm B, Stenvinkel P. Short-term treatment with sevelamer increases serum fetuin-a concentration and improves endothelial dysfunction in chronic kidney disease stage 4 patients. Clin J Am Soc Nephrol. 2008 Jan;3(1):61-8. doi: 10.2215/CJN.02810707. Epub 2007 Dec 5.

    PMID: 18057307DERIVED

MeSH Terms

Conditions

Vascular Diseases

Interventions

Sevelamercalcium acetate

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic Chemicals

Study Officials

  • Mahmut I Yilmaz

    Gulhane School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 13, 2007

First Posted

June 15, 2007

Last Updated

June 19, 2007

Record last verified: 2007-06