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Sevelamer, FGF-23 and Endothelial Dysfunction in Chronic Kidney Disease (CKD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01135615
First Posted: June 3, 2010
Last Update Posted: July 22, 2011
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.
Information provided by:
Gulhane School of Medicine
June 2, 2010
June 3, 2010
July 22, 2011
January 2008
April 2010   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01135615 on ClinicalTrials.gov Archive Site
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Sevelamer, FGF-23 and Endothelial Dysfunction in Chronic Kidney Disease (CKD)
Sevelamer, FGF-23 and Endothelial Dysfunction in CKD

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
We Investigated the Relationship Between Plasma FGF23 Levels and Endothelial Dysfunction in a Sizable Series of Incident Stage 3-4 CKD Patients.
  • 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
  • Sevelamer
    Interventions:
    • Drug: Sevelamer
    • Drug: calcium acetate
  • calcium acetate
    Intervention: Drug: calcium acetate
Yilmaz MI, Sonmez A, Saglam M, Yaman H, Kilic S, Eyileten T, Caglar K, Oguz Y, Vural A, Yenicesu M, Mallamaci F, Zoccali C. Comparison of calcium acetate and sevelamer on vascular function and fibroblast growth factor 23 in CKD patients: a randomized clinical trial. Am J Kidney Dis. 2012 Feb;59(2):177-85. doi: 10.1053/j.ajkd.2011.11.007. Epub 2011 Dec 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2010
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
 
NCT01135615
GATAFGF23Sevelamer
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Gulhane School of Medicine
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Gulhane School of Medicine
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP