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

Sponsor

Albany College of Pharmacy and Health Sciences (Other)

Overall Status

Terminated

CT.gov ID

NCT01277497

Collaborator

Albany Medical College (Other), Genzyme, a Sanofi Company (Industry)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease	Drug: Sevelamer carbonate Drug: Calcium acetate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Jan 1, 2016

Anticipated Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sevelamer carbonate 1,600 mg (2 x 800 mg) three times daily with meals for a total of 12 weeks	Drug: Sevelamer carbonate Sevelamer carbonate 1,600 mg three times daily with meals Other Names: Renvela
Active Comparator: Calcium acetate 1,334 mg (2 x 667 mg) three times daily with meals for a total of 12 weeks	Drug: Calcium acetate Calcium acetate 1,334 mg three times daily with meals for 12 weeks Other Names: Phoslo

Arm

Intervention/Treatment

Experimental: Sevelamer carbonate

1,600 mg (2 x 800 mg) three times daily with meals for a total of 12 weeks

Drug: Sevelamer carbonate

Sevelamer carbonate 1,600 mg three times daily with meals

Other Names:

Renvela

Active Comparator: Calcium acetate

1,334 mg (2 x 667 mg) three times daily with meals for a total of 12 weeks

Drug: Calcium acetate

Calcium acetate 1,334 mg three times daily with meals for 12 weeks

Other Names:

Phoslo

Outcome Measures

Primary Outcome Measures

The primary outcome measure will be the change in FGF-23 concentrations [12 weeks]

Secondary Outcome Measures

Change in vascular calcification biomarker levels [12 weeks]
Change in endothelial dysfunction biomarker levels. [12 Weeks]
Change in inflammatory biomarker levels [12 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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