A Study of Ferric Citrate to Improve Inflammation and Lipid Levels
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02661295|
Recruitment Status : Unknown
Verified January 2016 by Winthrop University Hospital.
Recruitment status was: Recruiting
First Posted : January 22, 2016
Last Update Posted : January 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease Hyperphosphatemia Chronic Inflammation||Drug: Ferric Citrate||Phase 4|
In patients with end stage renal disease (ESRD) receiving dialysis, the risk of cardiovascular death has been estimated to be 10-100 times higher than the general population without renal disease. This is due in part to high levels of inflammation and vascular calcification (large deposits of calcium in arteries) found in these patients. Chronic inflammation is particularly common in patients with ESRD. Parenteral iron therapy, which is common in patients on dialysis, may contribute to this inflammation and also a higher cardiovascular risk. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. In a study of 10,044 hemodialysis patients, treatment with a phosphate binder was associated with improved survival. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved for patients on hemodialysis. It has been shown to improve serum phosphorus levels and decrease intravenous iron requirements for patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid levels is unknown but investigators hypothesize that ferric citrate has the potential to improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous iron requirements and by improving lipid metabolism.
Ferric citrate has the potential to decrease cardiovascular risk through multiple mechanisms:
- acting as a non-calcium based binder to decrease serum phosphorus levels and vascular calcification,
- decreasing intravenous iron requirements which in turn may decrease inflammation,
- binding endotoxin (a harmful substance produced by microorganisms) in the gut and
- improving lipid metabolism.
The purpose of this study is to examine the effect of ferric citrate on inflammatory markers and lipid levels.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Ferric Citrate on Inflammation and Lipid Levels in Patients on Hemodialysis|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2016|
Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.
Drug: Ferric Citrate
Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and < 50% and ferritin ≥ 200 and < 500 ng/ml after a 2 week wash out period.
Other Name: Auryxia
- Percent change in cholesterol markers, mg/dL: Total Cholesterol, LDL, HDL, and Triglycerides. [ Time Frame: 0, 3 and 6 months ]
- Percent change in inflammatory markers, pg/mL: tumor necrosis factor -alpha (TNF-alpha), interleukin-6 (IL-6), and interleukin-8 (IL-8). [ Time Frame: 0, 3 and 6 months ]
- Percent change in Ferritin, ng/mL [ Time Frame: 0, 3 and 6 months ]
- Percent change in C reactive protein (CRP), mg/L [ Time Frame: 0, 3 and 6 months ]
- Percent change in Homocysteine, micromol/L [ Time Frame: 0, 3 and 6 months ]
- Percent change in intravenous iron use [ Time Frame: 0, 3 and 6 months ]
- Percent change in Calcium and Phosphorus, mg/dL [ Time Frame: Every 2 weeks for the first two months then at month 3,4,5,and 6. ]
- Percent change in parathyroid hormone (PTH), pg/mL [ Time Frame: 0, 3 and 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661295
|Contact: Candace Grant, MD||516-663-0333 ext email@example.com|
|Contact: Shayan Shirazian, MD||516-663-0333 ext firstname.lastname@example.org|
|United States, New York|
|Winthrop University Hospital||Recruiting|
|Mineola, New York, United States, 11501|
|Principal Investigator: Shayan Shirazian, MD|
|Principal Investigator:||Shayan Shirazian, MD||Winthrop University Hospital|