End Stage Renal DiseasePhase 4NCT02661295
A Study of Ferric Citrate to Improve Inflammation and Lipid Levels
A Phase 4 study testing Ferric Citrate in people with End Stage Renal Disease and Hyperphosphatemia, run by Winthrop University Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Hyperphosphatemia, Chronic Inflammation
- What is being tested?
- Ferric Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 15 Mar 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: The Effect of Ferric Citrate on Inflammation and Lipid Levels in Patients on Hemodialysis
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:
- 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.
- Being tested
- Ferric Citrate
- Medical subject headings
- Kidney Failure, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric CitrateDrug
Also called Auryxia
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.
| Study group | Role | What they receive |
|---|---|---|
| Ferric Citrate | Other | Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. Receives: Drug: Ferric Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Total Cholesterol
Percent change in total cholesterol (mg/dl) from Baseline to Month 6.
Measured: Baseline, Month 6
Percent Change in LDL-Cholesterol
Percent change in low-density lipoprotein (LDL) cholesterol (mg/dl) from baseline to Month 6
Measured: Baseline, Month 6
Percent Change in HDL Cholesterol
Percent change in high-density lipoprotein (HDL) cholesterol (mg/dl) from baseline to Month 6.
Measured: Baseline, Month 6
Percent Change in Triglycerides
Percent change in triglycerides (mg/dl) from baseline to Month 6.
Measured: Baseline, Month 6
Percent Change in TNF-alpha
Percent change in tumor necrosis factor (TNF)-alpha (pg/ml) from Baseline to Month 6.
Measured: Baseline, Month 6
Percent Change in IL-6
Percent change in interleukin 6 (IL-6) (pg/ml) from baseline to Month 6
Measured: Baseline, Month 6
Percent Change in IL-8
Percent change in interleukin 8 (IL-8) (pg/ml) from baseline to Month 6.
Measured: Baseline, Month 6
Percent Change in Ferritin
Percent change in ferritin (ng/ml) from baseline to Month 6.
Measured: Baseline, Month 6
Percent Change in C-reactive Protein
Percent change in C-reactive Protein (mg/L) from baseline to Month 6.
Measured: Baseline, Month 6
Percent Change in Homocysteine
Percent change in homocysteine (micromol/L) from baseline to Month 6.
Measured: Baseline, Month 6
Change in Intravenous Iron Use
Change in intravenous iron use (mg) from Baseline to Month 6.
Measured: Baseline, Month 6
Secondary outcomes (3)
Percent Change in Calcium
Percent change in calcium (mg/dL) from baseline to Month 6.
Measured: Baseline, Month 6
Percent Change in Phosphorus
Percent change in phosphorus (md/dl) from baseline to Month 6.
Measured: Baseline, Month 6
Percent Change in Parathyroid Hormone (PTH)
Percent change in PTH (pg/ml) from baseline to Month 6.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startJul 2015
- Primary completion29 Sep 2017
- Study completion15 Mar 2018
Why it stopped: 38 enrolled, 19 completed the study when loss of funding occurred
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will be designed as a single arm, prospective, experimental trial of 45 hemodialysis patients. Patients on hemodialysis at least 6 months and receiving a phosphate binder with serum phosphorus levels between 2.5 and 8.0 mg/dL, normal serum calcium levels, and on maintenance iron therapy are potentially eligible. Participants will receive ferric citrate after at least a 2 week washout period from previous phosphate binders if phosphorus is ≥ 5.5 mg/dl, calcium is within the normal range and ferritin ≥ 200 and \< 600 ng/ml. Ferric citrate will be titrated to maintain serum phosphorus and calcium within acceptable levels. Inflammatory markers and lipid levels will be tested at 0, 3, and 6 months.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Keryx Biopharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Candace Grant, MD, Principal investigator, NYU Winthrop
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661295
- Sponsor's protocol ID
- WUH 756275-1
- Status last verified
- Mar 2023
- First submitted
- 11 Jan 2016
- Last updated
- 20 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ferric Citrate on Inflammation and Lipid Levels in Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT02661295
- Acronym / sponsor ID
- WUH 756275-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 38 enrolled, 19 completed the study when loss of funding occurred
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Collaborators
- Keryx Biopharmaceuticals
- Study start
- Jul 2015
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Posted 20 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will be designed as a single arm, prospective, experimental trial of 45 hemodialysis patients. Patients on hemodialysis at least 6 months and receiving a phosphate binder with serum phosphorus levels between 2.5 and 8.0 mg/dL, normal serum calcium levels, and on maintenance iron therapy are potentially eligible. Participants will receive ferric citrate after at least a 2 week washout period from previous phosphate binders if phosphorus is ≥ 5.5 mg/dl, calcium is within the normal range and ferritin ≥ 200 and < 600 ng/ml. Ferric citrate will be titrated to maintain serum phosphorus and calcium within acceptable levels. Inflammatory markers and lipid levels will be tested at 0, 3, and 6 months.
| Arm | Type | Receives |
|---|---|---|
| Ferric Citrate | Other | Drug: Ferric CitrateFerric citrate at a starting dose of 2 tablets with each meal will be given to all participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- Intact PTH< 70 pg/ml or > 1,000 pg/ml
- Oral iron use
- Vitamin C supplement use
- Parathyroidectomy
- Active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric CitrateAlso: AuryxiaStudy 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. | Drug | Ferric Citrate |
Primary outcome
Percent Change in Total Cholesterol
Time frame: Baseline, Month 6
Percent change in total cholesterol (mg/dl) from Baseline to Month 6.
Percent Change in LDL-Cholesterol
Time frame: Baseline, Month 6
Percent change in low-density lipoprotein (LDL) cholesterol (mg/dl) from baseline to Month 6
Percent Change in HDL Cholesterol
Time frame: Baseline, Month 6
Percent change in high-density lipoprotein (HDL) cholesterol (mg/dl) from baseline to Month 6.
Percent Change in Triglycerides
Time frame: Baseline, Month 6
Percent change in triglycerides (mg/dl) from baseline to Month 6.
Percent Change in TNF-alpha
Time frame: Baseline, Month 6
Percent change in tumor necrosis factor (TNF)-alpha (pg/ml) from Baseline to Month 6.
Percent Change in IL-6
Time frame: Baseline, Month 6
Percent change in interleukin 6 (IL-6) (pg/ml) from baseline to Month 6
Percent Change in IL-8
Time frame: Baseline, Month 6
Percent change in interleukin 8 (IL-8) (pg/ml) from baseline to Month 6.
Percent Change in Ferritin
Time frame: Baseline, Month 6
Percent change in ferritin (ng/ml) from baseline to Month 6.
Percent Change in C-reactive Protein
Time frame: Baseline, Month 6
Percent change in C-reactive Protein (mg/L) from baseline to Month 6.
Percent Change in Homocysteine
Time frame: Baseline, Month 6
Percent change in homocysteine (micromol/L) from baseline to Month 6.
Change in Intravenous Iron Use
Time frame: Baseline, Month 6
Change in intravenous iron use (mg) from Baseline to Month 6.
3 secondary outcomes
Percent Change in Calcium
Time frame: Baseline, Month 6
Percent Change in Phosphorus
Time frame: Baseline, Month 6
Percent Change in Parathyroid Hormone (PTH)
Time frame: Baseline, Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candace Grant, MD principal investigator
NYU Winthrop
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric Citrate in people with End Stage Renal Disease and Hyperphosphatemia, run by Winthrop University Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Total Cholesterol (time frame: Baseline, Month 6). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.