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Sevelamer, Fetuin-A and Endothelial Dysfunction in CKD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00486772
Recruitment Status : Completed
First Posted : June 15, 2007
Last Update Posted : June 19, 2007
Information provided by:
Gulhane School of Medicine

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.

Condition or disease Intervention/treatment Phase
Vascular Diseases Drug: Sevelamer (Renagel), calcium acetate (Phos-ex) Phase 4

Detailed Description:

CKD stage 4 patients older than 18 years of age and willing to participate to the study were screened. Those who had serum phosphorus > 5.5 mg/dl were evaluated for the study. Patients with diabetes mellitus, history of coronary artery disease, smokers and those taking statins or renin-angiotensin blockers were excluded because of the effect of these factors on endothelial dysfunction. Of 62 screened patients 50 met the study criteria and were included in this study. Thirty-two healthy subjects were studied as controls. The ethical committee of Gulhane School of Medicine approved the study and written informed consent was obtained from all patients.

Study design:

This was a randomized study conducted from 2005 through 2006 in Gulhane School of Medicine. The Outpatient Clinic of Department of Nephrology is a tertiary referral center. At admission, most patients were untreated (including phosphate binders) or treated only with antihypertensive agents. After the first evaluation, patients receiving phosphate binders (n=9) underwent a 2-week washout period. Patients who developed a phosphate level >5.5 mg/dl during this period were included in the study. Patients were randomly assigned in 1:1 ratio to receive sevelamer (Renagel capsule) or calcium acetate (Phos Ex tablet). The treatment phase was 8 weeks. During the study period serum calcium and phosphorus concentration were measured every 2 weeks and the dose of phosphate binders were titrated to achieve a serum phosphorus concentration < 5.5 mg/dl. The starting dose for sevelamer was 1-2 capsules (800 mg) three times a day and for calcium acetate (1000 mg) 1 tablet three times a day. The medications were given with meal and the doses were increased as needed. Patients were not given calcitriol during the study period.

Fasting blood samples were taken before and after the study to measure serum creatinine, serum albumin, hs-CRP, insulin, iPTH, lipid profile and serum fetuin-A concentration. Additionally, flow-mediated dilatation (FMD) was also evaluated before and after the study.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Prevention

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00486772

Sponsors and Collaborators
Gulhane School of Medicine
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Principal Investigator: Mahmut I Yilmaz Gulhane School of Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00486772     History of Changes
Other Study ID Numbers: 1-Yilmaz
First Posted: June 15, 2007    Key Record Dates
Last Update Posted: June 19, 2007
Last Verified: June 2007
Keywords provided by Gulhane School of Medicine:
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.
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Calcium acetate
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action