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

NCT01277497 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-01-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Sevelamer carbonate

Sevelamer carbonate 1,600 mg three times daily with meals

DRUG

Calcium acetate

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

Sponsors & Collaborators

  • Albany Medical College

    collaborator OTHER

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • Albany College of Pharmacy and Health Sciences

    lead OTHER

Principal Investigators

  • Darius L Mason, Pharm.D. · Albany College of Pharmacy and Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01277497 on ClinicalTrials.gov