Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4

Chronic Kidney Disease Clinical Trial

Official title:

A Randomized Study on the Effects of Sevelamer Carbonate Versus Calcium Acetate on Biomarkers of Vascular Calcification, Inflammation, and Endothelial Dysfunction in Chronic Kidney Disease Stages 3 and 4

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01277497
• Other study ID #: 2902
• Status: Terminated
• Phase: Phase 4
• First received: January 6, 2011
• Last updated: January 13, 2016
• Start date: January 2011
• Est. completion date: March 2016

Study information

• Verified date: January 2016
• Source: Albany College of Pharmacy and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Chronic kidney disease (CKD) patients often have high levels of a substance called fibroblast growth factor-23 (FGF-23), a phosphorus excreting hormone, which has been related to heart disease. As kidney function declines, less phosphorus is removed by the kidneys and as a result phosphorus accumulates in the blood. In response to elevated phosphorus levels, more FGF-23 is released to help facilitate the excretion of extra phosphorus into the urine. In addition to effects on FGF-23, increased phosphorus levels can lead to calcification (hardening) of the blood vessels in the CKD population.

Phosphate binding medicines are used in CKD patients to lower the amount of phosphorus absorbed by the stomach and intestines after eating meals and snacks. In patients with CKD, studies have shown that phosphate binders can lower FGF-23 levels in the blood. Lowering FGF-23 levels in CKD patients may also lower substances in the blood that cause calcification of blood vessels in the CKD population.

This study is being done to determine if using phosphate binders, either sevelamer carbonate or calcium acetate, in the earlier stages kidney disease (before dialysis) can decrease FGF-23 and biomarkers (substances in the blood) associated with hardening of the blood vessels and heart disease.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males or females = 18 years of age at start of screening

• CKD stage 3 or 4 defined by an eGFR 15 - 60 mL/min/1.73m2

• Not expected to start dialysis for 8 months

• Serum intact PTH < 500 pg/mL during screening period

• On a stable ACE inhibitor/ARB regimen for 30 days prior to screening

Exclusion Criteria:

• History of any of the following diseases: congestive heart failure, MI within the last 6 months, cerebrovascular accident, significant valvular disease, malignancy

• Currently receiving erythropoiesis stimulating agent or IV iron therapy

• History of inflammatory/autoimmune disease

• History of polycystic kidney disease

• HIV positive or AIDS

• Pregnant or breastfeeding

• Receiving activated Vitamin D analogs, nutritional vitamin D agents > 2,000 IU/day, or calcimimetics with in the last 3 months

• Significant GI disorder

• Proteinuria >3.5 g/24 hours

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Vascular Calcification

Intervention

Drug:
• Sevelamer carbonate
Sevelamer carbonate 1,600 mg three times daily with meals
• Calcium acetate
Calcium acetate 1,334 mg three times daily with meals for 12 weeks

Locations

Country	Name	City	State
United States	Albany Medical Center South Clinical Campus	Albany	New York

Sponsors (3)

Lead Sponsor	Collaborator
Albany College of Pharmacy and Health Sciences	Albany Medical College, Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure will be the change in FGF-23 concentrations		12 weeks	No
Secondary	Change in vascular calcification biomarker levels		12 weeks	No
Secondary	Change in endothelial dysfunction biomarker levels.		12 Weeks	No
Secondary	Change in inflammatory biomarker levels		12 Weeks	No