A Phase 4 interventional study of Sevelamer carbonate and Calcium acetate in Chronic Kidney Disease, sponsored by Albany College of Pharmacy and Health Sciences. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-14.
Sponsored by Albany College of Pharmacy and Health Sciences · Phase 4, Interventional, and Prevention
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Albany College of Pharmacy and Health Sciences is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1,600 mg (2 x 800 mg) three times daily with meals for a total of 12 weeks
Drug: Sevelamer carbonate
1,334 mg (2 x 667 mg) three times daily with meals for a total of 12 weeks
Drug: Calcium acetate
Sevelamer carbonate 1,600 mg three times daily with meals
Also known as: Renvela
Calcium acetate 1,334 mg three times daily with meals for 12 weeks
Also known as: Phoslo
The primary outcome measure will be the change in FGF-23 concentrations
Time frame: 12 weeks
Change in vascular calcification biomarker levels
Time frame: 12 weeks
Change in endothelial dysfunction biomarker levels.
Time frame: 12 Weeks
Change in inflammatory biomarker levels
Time frame: 12 Weeks
This study is terminated, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Albany College of Pharmacy and Health Sciences