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

NCT01135615 | Completed Phase 4

• 1 other identifier: GATAFGF23Sevelamer
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

We Investigated the Relationship Between Plasma FGF23 Levels and Endothelial Dysfunction in a Sizable Series of Incident Stage 3-4 CKD Patients.

Keywords

FGF-23, endothelial dysfunction, sevelamer

Study Arms (2)

Sevelamer

OTHER

Drug: Sevelamer; Drug: calcium acetate

calcium acetate

OTHER

Drug: calcium acetate

Interventions

Sevelamer DRUG

The starting dose for sevelamer was 1-2 capsules (800 mg) three times a day

Sevelamer

calcium acetate DRUG

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

Sevelamer; calcium acetate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Gulhane School of Medicine

Ankara, 06018, Turkey (Türkiye)

Location

Related Publications (2)

• 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: 40576086 DERIVED

• 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.

  PMID: 22137672 DERIVED

MeSH Terms

Interventions

Sevelamer; calcium acetate

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals

Study Design

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

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 3, 2010
• Study Start: January 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 22, 2011

Record last verified: 2010-05

Locations

TU (1)