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Trial record 7 of 380 for:    FERRIC CATION

A Study of Ferric Citrate to Improve Inflammation and Lipid Levels

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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
Sponsor:
Collaborator:
Keryx Biopharmaceuticals
Information provided by (Responsible Party):
Winthrop University Hospital

Brief Summary:
The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis is 10-100 times higher than the normal population. This is due in part to high levels of inflammation and vascular calcification found in these patients. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Hyperphosphatemia Chronic Inflammation Drug: Ferric Citrate Phase 4

Detailed Description:

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:

  1. acting as a non-calcium based binder to decrease serum phosphorus levels and vascular calcification,
  2. decreasing intravenous iron requirements which in turn may decrease inflammation,
  3. binding endotoxin (a harmful substance produced by microorganisms) in the gut and
  4. improving lipid metabolism.

The purpose of this study is to examine the effect of ferric citrate on inflammatory markers and lipid levels.


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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Ferric Citrate
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




Primary Outcome Measures :
  1. Percent change in cholesterol markers, mg/dL: Total Cholesterol, LDL, HDL, and Triglycerides. [ Time Frame: 0, 3 and 6 months ]
  2. 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 ]
  3. Percent change in Ferritin, ng/mL [ Time Frame: 0, 3 and 6 months ]
  4. Percent change in C reactive protein (CRP), mg/L [ Time Frame: 0, 3 and 6 months ]
  5. Percent change in Homocysteine, micromol/L [ Time Frame: 0, 3 and 6 months ]
  6. Percent change in intravenous iron use [ Time Frame: 0, 3 and 6 months ]

Secondary Outcome Measures :
  1. 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. ]
  2. Percent change in parathyroid hormone (PTH), pg/mL [ Time Frame: 0, 3 and 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemodialysis treatment for ≥ 6 months
  • Phosphate binder treatment for ≥ to 1 month
  • Maintenance iron therapy with no more than 125mg IV iron weekly≥ to 1 month
  • Serum phosphorus levels between 2.5 and 8 at screening
  • Serum phosphorus ≥ to 6.0 mg/dL after a 2 week washout period.
  • Serum ferritin ≥ 200 and < 600ng/ml after a 2 week washout period
  • Serum calcium levels within normal range
  • Predicted survival greater than 6 months

Exclusion Criteria:

  • Intact PTH< 70 pg/ml or > 1,000 pg/ml
  • Oral iron use
  • Vitamin C supplement use
  • Parathyroidectomy
  • Active malignancy
  • Hemodialysis via an intravenous catheter or arteriovenous (AV) graft
  • Received > 250mg of IV iron over the two weeks prior to screening
  • Whole blood transfusion within 3 months prior to screening
  • Active bleeding other than from the dialysis access
  • Hospitalization within one month prior to screening
  • current infection
  • Ongoing or uncontrolled inflammatory disorder
  • Liver cirrhosis
  • Likelihood of imminent renal transplantation

Information from the National Library of Medicine

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


Contacts
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Contact: Candace Grant, MD 516-663-0333 ext 9054 cgrant@winthrop.org
Contact: Shayan Shirazian, MD 516-663-0333 ext 2170 sshirazian@winthrop.org

Locations
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United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Principal Investigator: Shayan Shirazian, MD         
Sponsors and Collaborators
Winthrop University Hospital
Keryx Biopharmaceuticals
Investigators
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Principal Investigator: Shayan Shirazian, MD Winthrop University Hospital

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Responsible Party: Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT02661295     History of Changes
Other Study ID Numbers: 756275-1
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Ferric Compounds
Kidney Failure, Chronic
Hyperphosphatemia
Inflammation
Pathologic Processes
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Hematinics