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Sevelamer, FGF-23 and Endothelial Dysfunction in Chronic Kidney Disease (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: NCT01135615
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : July 22, 2011
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 FGF23 levels concentrations and ED seen in CKD patients.

The researchers investigated the relationship between plasma FGF23 levels and the forearm blood flow response to ischemia in the forearm in a sizable series of incident stage 3-4 CKD patients.

Condition or disease Intervention/treatment Phase
We Investigated the Relationship Between Plasma FGF23 Levels and Endothelial Dysfunction in a Sizable Series of Incident Stage 3-4 CKD Patients. Drug: Sevelamer Drug: calcium acetate 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 192 screened patients 100 met the study criteria and were included in this study. Thirty-seven 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 2008 through 2010 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=17) 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, 25 (OH) Vit D, iPTH, lipid profile and serum FGF-23 concentration. Additionally, flow-mediated dilatation (FMD) and Intima Media Thickness (IMT) were also evaluated before and after the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Sevelamer, FGF-23 and Endothelial Dysfunction in CKD
Study Start Date : January 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Sevelamer Drug: Sevelamer
The starting dose for sevelamer was 1-2 capsules (800 mg) three times a day

Drug: calcium acetate
calcium acetate (1000 mg) 1 tablet three times a day

calcium acetate Drug: calcium acetate
calcium acetate (1000 mg) 1 tablet three times a day

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): NCT01135615

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Gulhane School of Medicine
Ankara, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT01135615    
Other Study ID Numbers: GATAFGF23Sevelamer
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: May 2010
Keywords provided by Gulhane School of Medicine:
FGF-23, endothelial dysfunction, sevelamer
Additional relevant MeSH terms:
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Calcium acetate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action