Trial Outcomes & Findings for A Study of Ferric Citrate to Improve Inflammation and Lipid Levels (NCT NCT02661295)

NCT ID: NCT02661295

Last Updated: 2023-04-20

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 38 participants
• Primary outcome timeframe: Baseline, Month 6
• Results posted on: 2023-04-20

Participant Flow

Participant milestones

Measure	Ferric Citrate Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.
Overall Study STARTED	38
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Measure	Ferric Citrate Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.
Overall Study Death	1
Overall Study Transferred Out	1
Overall Study Kidney Transplant	1
Overall Study Withdrawn due to side effects	8
Overall Study Withdrawn due to access type	1
Overall Study Withdrawn due to allergies	1
Overall Study Withdrawn due to non-compliance	1
Overall Study Withdrawal by Subject	3
Overall Study Failed screening	2

Baseline Characteristics

A Study of Ferric Citrate to Improve Inflammation and Lipid Levels

Baseline characteristics by cohort

Measure	Ferric Citrate n=19 Participants Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.
Age, Continuous	57.8 years STANDARD_DEVIATION 15.2 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 6

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

Outcome measures

Measure

Ferric Citrate n=19 Participants Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.

Percent Change in Total Cholesterol

1.58 Percent change Standard Deviation 33.77

PRIMARY outcome

Timeframe: Baseline, Month 6

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

Outcome measures

Measure

Ferric Citrate n=19 Participants Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.

Percent Change in LDL-Cholesterol

-0.05 Percent change Standard Deviation 32.47

PRIMARY outcome

Timeframe: Baseline, Month 6

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

Outcome measures

Measure

Ferric Citrate n=19 Participants Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.

Percent Change in HDL Cholesterol

1.32 percent change Standard Deviation 6.16

PRIMARY outcome

Timeframe: Baseline, Month 6

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

Outcome measures

Measure

Ferric Citrate n=19 Participants Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.

Percent Change in Triglycerides

-5.11 Percent change Standard Deviation 67.69

PRIMARY outcome

Timeframe: Baseline, Month 6

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

Outcome measures

Measure

Ferric Citrate n=19 Participants Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.

Percent Change in TNF-alpha

-0.1 percent change Standard Deviation 1.77

PRIMARY outcome

Timeframe: Baseline, Month 6

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

Outcome measures

Measure

Ferric Citrate n=19 Participants Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.

Percent Change in IL-6

-1.78 percent change Standard Deviation 19.5

PRIMARY outcome

Timeframe: Baseline, Month 6

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

Outcome measures

Measure

Ferric Citrate n=19 Participants Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.

Percent Change in IL-8

101.96 Percent change Standard Deviation 422.8

PRIMARY outcome

Timeframe: Baseline, Month 6

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

Outcome measures

Measure

Ferric Citrate n=19 Participants Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.

Percent Change in Ferritin

51.11 percent change Standard Deviation 296.4

PRIMARY outcome

Timeframe: Baseline, Month 6

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

Outcome measures

Measure

Ferric Citrate n=19 Participants Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.

Percent Change in C-reactive Protein

8.89 percent change Standard Deviation 35.49

PRIMARY outcome

Timeframe: Baseline, Month 6

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

Outcome measures

Measure

Ferric Citrate n=19 Participants Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.

Percent Change in Homocysteine

1.35 percent change Standard Deviation 7.31

PRIMARY outcome

Timeframe: Baseline, Month 6

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

Outcome measures

Measure

Ferric Citrate n=19 Participants Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.

Change in Intravenous Iron Use

-588.8 mg Standard Deviation 807.8

SECONDARY outcome

Timeframe: Baseline, Month 6

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

Outcome measures

Measure

Ferric Citrate n=19 Participants Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.

Percent Change in Calcium

0.08 Percent change Standard Deviation 0.53

SECONDARY outcome

Timeframe: Baseline, Month 6

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

Outcome measures

Measure

Ferric Citrate n=19 Participants Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.

Percent Change in Phosphorus

-1.58 Percent change Standard Deviation 1.87

SECONDARY outcome

Timeframe: Baseline, Month 6

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

Outcome measures

Measure

Ferric Citrate n=19 Participants Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.

Percent Change in Parathyroid Hormone (PTH)

36.47 Percent change Standard Deviation 280.3

Adverse Events

Ferric Citrate

Serious events: 14 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Ferric Citrate n=38 participants at risk Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. 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.
Renal and urinary disorders Renal transplant	2.6% 1/38 • 6 months
Cardiac disorders Coronary artery bypass graft	2.6% 1/38 • 6 months
Metabolism and nutrition disorders Hypoglycemia	2.6% 1/38 • 6 months
Nervous system disorders Encephalomalacia	2.6% 1/38 • 6 months
Musculoskeletal and connective tissue disorders Spinal Stenosis	2.6% 1/38 • 6 months
Gastrointestinal disorders Enteritis	2.6% 1/38 • 6 months
Injury, poisoning and procedural complications Arteriovenous fistula site complication	2.6% 1/38 • 6 months
Respiratory, thoracic and mediastinal disorders Dyspnea	5.3% 2/38 • 6 months
Blood and lymphatic system disorders Anemia	2.6% 1/38 • 6 months
Respiratory, thoracic and mediastinal disorders Pulmonary edema	5.3% 2/38 • 6 months
Injury, poisoning and procedural complications Acetabulum fracture	2.6% 1/38 • 6 months
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.6% 1/38 • 6 months
Respiratory, thoracic and mediastinal disorders Fluid overload	2.6% 1/38 • 6 months
General disorders Fatigue	2.6% 1/38 • 6 months
Musculoskeletal and connective tissue disorders Back pain	2.6% 1/38 • 6 months
Nervous system disorders Lethargy	2.6% 1/38 • 6 months
General disorders Chest pain	2.6% 1/38 • 6 months
Cardiac disorders Cardiac arrest	2.6% 1/38 • 6 months
Product Issues Catheter infection	2.6% 1/38 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Candace Grant, MD

NYU Langone Health

Phone: 516-663-0333

Email: candace.grant@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place