A Study of Ferric Citrate to Improve Inflammation and Lipid Levels

NCT02661295 | Terminated Phase 4 Results

• 1 other identifier: WUH 756275-1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; Hyperphosphatemia; Chronic Inflammation

Outcome Measures

Primary Outcomes (11)

• Percent Change in Total Cholesterol

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

  Baseline, Month 6

• Percent Change in LDL-Cholesterol

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

  Baseline, Month 6

• Percent Change in HDL Cholesterol

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

  Baseline, Month 6

• Percent Change in Triglycerides

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

  Baseline, Month 6

• Percent Change in TNF-alpha

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

  Baseline, Month 6

• Percent Change in IL-6

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

  Baseline, Month 6

• Percent Change in IL-8

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

  Baseline, Month 6

• Percent Change in Ferritin

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

  Baseline, Month 6

• Percent Change in C-reactive Protein

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

  Baseline, Month 6

• Percent Change in Homocysteine

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

  Baseline, Month 6

• Change in Intravenous Iron Use

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

  Baseline, Month 6

Secondary Outcomes (3)

• Percent Change in Calcium

  Baseline, Month 6

• Percent Change in Phosphorus

  Baseline, Month 6

• Percent Change in Parathyroid Hormone (PTH)

  Baseline, Month 6

Study Arms (1)

Ferric Citrate

OTHER

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

Drug: Ferric Citrate

Interventions

Ferric Citrate DRUG

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

Ferric Citrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Winthrop University Hospital: lead
• Keryx Biopharmaceuticals: collaborator

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Hyperphosphatemia

Interventions

ferric citrate

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Candace Grant, MD
• Organization: NYU Langone Health

candace.grant@nyulangone.org

516-663-0333

Study Officials

• Candace Grant, MD

  NYU Winthrop

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 22, 2016
• Study Start: July 1, 2015
• Primary Completion: September 29, 2017
• Study Completion: March 15, 2018
• Last Updated: April 20, 2023
• Results First Posted: April 20, 2023

Record last verified: 2023-03

Locations

US (1)