ClinicalTrials.gg
Sign In
TerminatedNCT02661295Updated Apr 20, 2023Results posted

A Study of Ferric Citrate to Improve Inflammation and Lipid Levels

A Phase 4 interventional study of Ferric Citrate in End Stage Renal Disease, Hyperphosphatemia and Chronic Inflammation, sponsored by Winthrop University Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-20.

Sponsored by Winthrop University Hospital · Phase 4, Interventional, and Other

Why this study was terminated
38 enrolled, 19 completed the study when loss of funding occurred
Phase
Phase 4
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • End Stage Renal Disease
  • Hyperphosphatemia
  • Chronic Inflammation
03

In context

Kidney Failure, Chronic

2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

This study's enrollment of 38 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Winthrop University Hospital is the lead sponsor of 42 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • 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

Exclusion Criteria:

  • Intact PTH\< 70 pg/ml or > 1,000 pg/ml
  • Oral iron use
  • Vitamin C supplement use
  • Parathyroidectomy
  • Active
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Other
    Ferric Citrate

    Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.

    Drug: Ferric Citrate

Interventions

  • DrugFerric 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.

    Also known as: Auryxia

06

What researchers measure

Primary outcomes

  1. Percent Change in Total Cholesterol

    Percent change in total cholesterol (mg/dl) from Baseline to Month 6.

    Time frame: Baseline, Month 6

  2. Percent Change in LDL-Cholesterol

    Percent change in low-density lipoprotein (LDL) cholesterol (mg/dl) from baseline to Month 6

    Time frame: Baseline, Month 6

  3. Percent Change in HDL Cholesterol

    Percent change in high-density lipoprotein (HDL) cholesterol (mg/dl) from baseline to Month 6.

    Time frame: Baseline, Month 6

  4. Percent Change in Triglycerides

    Percent change in triglycerides (mg/dl) from baseline to Month 6.

    Time frame: Baseline, Month 6

  5. Percent Change in TNF-alpha

    Percent change in tumor necrosis factor (TNF)-alpha (pg/ml) from Baseline to Month 6.

    Time frame: Baseline, Month 6

  6. Percent Change in IL-6

    Percent change in interleukin 6 (IL-6) (pg/ml) from baseline to Month 6

    Time frame: Baseline, Month 6

  7. Percent Change in IL-8

    Percent change in interleukin 8 (IL-8) (pg/ml) from baseline to Month 6.

    Time frame: Baseline, Month 6

  8. Percent Change in Ferritin

    Percent change in ferritin (ng/ml) from baseline to Month 6.

    Time frame: Baseline, Month 6

  9. Percent Change in C-reactive Protein

    Percent change in C-reactive Protein (mg/L) from baseline to Month 6.

    Time frame: Baseline, Month 6

  10. Percent Change in Homocysteine

    Percent change in homocysteine (micromol/L) from baseline to Month 6.

    Time frame: Baseline, Month 6

  11. Change in Intravenous Iron Use

    Change in intravenous iron use (mg) from Baseline to Month 6.

    Time frame: Baseline, Month 6

Secondary outcomes

  1. Percent Change in Calcium

    Percent change in calcium (mg/dL) from baseline to Month 6.

    Time frame: Baseline, Month 6

  2. Percent Change in Phosphorus

    Percent change in phosphorus (md/dl) from baseline to Month 6.

    Time frame: Baseline, Month 6

  3. Percent Change in Parathyroid Hormone (PTH)

    Percent change in PTH (pg/ml) from baseline to Month 6.

    Time frame: Baseline, Month 6

07

Results

Posted Apr 20, 2023

Participant flow

Participant flow — Overall Study
MilestoneFerric Citrate
Started38
Completed19
Not completed19
Withdrew: Death1
Withdrew: Transferred out1
Withdrew: Kidney transplant1
Withdrew: Withdrawn due to side effects8
Withdrew: Withdrawn due to access type1
Withdrew: Withdrawn due to allergies1
Withdrew: Withdrawn due to non-compliance1
Withdrew: Withdrawal by subject3
Withdrew: Failed screening2

Outcome measures

PrimaryPercent Change in Total Cholesterol

Percent change in total cholesterol (mg/dl) from Baseline to Month 6.

Time frame:
Baseline, Month 6
Reported as:
Mean · Percent change
Percent Change in Total Cholesterol
Percent changeFerric Citrate
Percent Change in Total Cholesterol1.58 ± 33.77
PrimaryPercent Change in LDL-Cholesterol

Percent change in low-density lipoprotein (LDL) cholesterol (mg/dl) from baseline to Month 6

Time frame:
Baseline, Month 6
Reported as:
Mean · Percent change
Percent Change in LDL-Cholesterol
Percent changeFerric Citrate
Percent Change in LDL-Cholesterol-0.05 ± 32.47
PrimaryPercent Change in HDL Cholesterol

Percent change in high-density lipoprotein (HDL) cholesterol (mg/dl) from baseline to Month 6.

Time frame:
Baseline, Month 6
Reported as:
Mean · percent change
Percent Change in HDL Cholesterol
percent changeFerric Citrate
Percent Change in HDL Cholesterol1.32 ± 6.16
PrimaryPercent Change in Triglycerides

Percent change in triglycerides (mg/dl) from baseline to Month 6.

Time frame:
Baseline, Month 6
Reported as:
Mean · Percent change
Percent Change in Triglycerides
Percent changeFerric Citrate
Percent Change in Triglycerides-5.11 ± 67.69
PrimaryPercent Change in TNF-alpha

Percent change in tumor necrosis factor (TNF)-alpha (pg/ml) from Baseline to Month 6.

Time frame:
Baseline, Month 6
Reported as:
Mean · percent change
Percent Change in TNF-alpha
percent changeFerric Citrate
Percent Change in TNF-alpha-0.1 ± 1.77
PrimaryPercent Change in IL-6

Percent change in interleukin 6 (IL-6) (pg/ml) from baseline to Month 6

Time frame:
Baseline, Month 6
Reported as:
Mean · percent change
Percent Change in IL-6
percent changeFerric Citrate
Percent Change in IL-6-1.78 ± 19.5
PrimaryPercent Change in IL-8

Percent change in interleukin 8 (IL-8) (pg/ml) from baseline to Month 6.

Time frame:
Baseline, Month 6
Reported as:
Mean · Percent change
Percent Change in IL-8
Percent changeFerric Citrate
Percent Change in IL-8101.96 ± 422.8
PrimaryPercent Change in Ferritin

Percent change in ferritin (ng/ml) from baseline to Month 6.

Time frame:
Baseline, Month 6
Reported as:
Mean · percent change
Percent Change in Ferritin
percent changeFerric Citrate
Percent Change in Ferritin51.11 ± 296.4
PrimaryPercent Change in C-reactive Protein

Percent change in C-reactive Protein (mg/L) from baseline to Month 6.

Time frame:
Baseline, Month 6
Reported as:
Mean · percent change
Percent Change in C-reactive Protein
percent changeFerric Citrate
Percent Change in C-reactive Protein8.89 ± 35.49
PrimaryPercent Change in Homocysteine

Percent change in homocysteine (micromol/L) from baseline to Month 6.

Time frame:
Baseline, Month 6
Reported as:
Mean · percent change
Percent Change in Homocysteine
percent changeFerric Citrate
Percent Change in Homocysteine1.35 ± 7.31
PrimaryChange in Intravenous Iron Use

Change in intravenous iron use (mg) from Baseline to Month 6.

Time frame:
Baseline, Month 6
Reported as:
Mean · mg
Change in Intravenous Iron Use
mgFerric Citrate
Change in Intravenous Iron Use-588.8 ± 807.8
SecondaryPercent Change in Calcium

Percent change in calcium (mg/dL) from baseline to Month 6.

Time frame:
Baseline, Month 6
Reported as:
Mean · Percent change
Percent Change in Calcium
Percent changeFerric Citrate
Percent Change in Calcium0.08 ± 0.53
SecondaryPercent Change in Phosphorus

Percent change in phosphorus (md/dl) from baseline to Month 6.

Time frame:
Baseline, Month 6
Reported as:
Mean · Percent change
Percent Change in Phosphorus
Percent changeFerric Citrate
Percent Change in Phosphorus-1.58 ± 1.87
SecondaryPercent Change in Parathyroid Hormone (PTH)

Percent change in PTH (pg/ml) from baseline to Month 6.

Time frame:
Baseline, Month 6
Reported as:
Mean · Percent change
Percent Change in Parathyroid Hormone (PTH)
Percent changeFerric Citrate
Percent Change in Parathyroid Hormone (PTH)36.47 ± 280.3

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ferric Citrate1/38 (2.6%)14/38 (36.8%)0/38 (0%)
Most frequent serious events
Showing 10 of 19
Most frequent serious events
EventFerric Citrate
DyspneaRespiratory, thoracic and mediastinal disorders2/38
Pulmonary edemaRespiratory, thoracic and mediastinal disorders2/38
Renal transplantRenal and urinary disorders1/38
Coronary artery bypass graftCardiac disorders1/38
HypoglycemiaMetabolism and nutrition disorders1/38
EncephalomalaciaNervous system disorders1/38
Spinal StenosisMusculoskeletal and connective tissue disorders1/38
EnteritisGastrointestinal disorders1/38
Arteriovenous fistula site complicationInjury, poisoning and procedural complications1/38
AnemiaBlood and lymphatic system disorders1/38

Baseline characteristics

Age, Continuous
Age, Continuous(years)Ferric Citrate
Mean57.8 ± 15.2
Sex: Female, Male
Sex: Female, Male(Participants)Ferric Citrate
Female4
Male15
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Ferric Citrate
Hispanic or Latino4
Not Hispanic or Latino15
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Ferric Citrate
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American6
White12
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Ferric Citrate
United States19
08

Study locations

1 site
  • Winthrop University Hospital
    Mineola, New York 11501, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02661295
Lead sponsor
Winthrop University Hospital
Collaborators
Keryx Biopharmaceuticals
Responsible party
Sponsor
First posted
Jan 22, 2016
Start date
Jul 2015
Primary completion
Sep 29, 2017
Completion
Mar 15, 2018
Results posted
Apr 20, 2023
Last update
Apr 20, 2023

Study contacts

Candace Grant, MD
principal investigator · NYU Winthrop

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Studies of the drug tested here: Ferric citrate

Other studies in this condition

Kidney Failure, Chronic →

Other studies from this sponsor

Winthrop University Hospital

Start the discussion