Trial Outcomes & Findings for Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency (NCT NCT02888171)
NCT ID: NCT02888171
Last Updated: 2020-03-24
Results Overview
The change in serum ferritin concentrations from the baseline of the study to the 12 week time point.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2020-03-24
Participant Flow
Participants were recruited from the nephrology outpatient clinics at the University of Alabama at Birmingham (UAB) from September 2016 to October 2018.
Participants who were taking oral iron supplements at the time of the screening visit were allowed to participate but had to undergo a wash-out period of at least 4 weeks prior to randomization.
Participant milestones
| Measure |
Ferric Citrate
Participants randomized to the ferric citrate arm will receive 2 grams of ferric citrate three times a day with each meal.
ferric citrate: Participants randomized to the ferric citrate arm will take 2 grams of ferric citrate three times a day with meals.
|
Ferrous Sulfate
Participants randomized to the ferrous sulfate arm will receive 325 mg of ferrous sulfate three times a day
ferrous sulfate: Participants randomized to the ferrous sulfate arm will take 325 mg of ferrous sulfate three times a day.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Ferric Citrate
Participants randomized to the ferric citrate arm will receive 2 grams of ferric citrate three times a day with each meal.
ferric citrate: Participants randomized to the ferric citrate arm will take 2 grams of ferric citrate three times a day with meals.
|
Ferrous Sulfate
Participants randomized to the ferrous sulfate arm will receive 325 mg of ferrous sulfate three times a day
ferrous sulfate: Participants randomized to the ferrous sulfate arm will take 325 mg of ferrous sulfate three times a day.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
Baseline characteristics by cohort
| Measure |
Ferric Citrate
n=30 Participants
Participants randomized to the ferric citrate arm will receive 2 grams of ferric citrate three times a day with each meal.
ferric citrate: Participants randomized to the ferric citrate arm will take 2 grams of ferric citrate three times a day with meals.
|
Ferrous Sulfate
n=30 Participants
Participants randomized to the ferrous sulfate arm will receive 325 mg of ferrous sulfate three times a day
ferrous sulfate: Participants randomized to the ferrous sulfate arm will take 325 mg of ferrous sulfate three times a day.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 12 • n=99 Participants
|
63 years
STANDARD_DEVIATION 11 • n=107 Participants
|
62 years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
body mass index
|
37 kg/m^2
STANDARD_DEVIATION 8 • n=99 Participants
|
36 kg/m^2
STANDARD_DEVIATION 9 • n=107 Participants
|
36 kg/m^2
STANDARD_DEVIATION 8 • n=206 Participants
|
|
systolic blood pressure
|
136 mmHg
STANDARD_DEVIATION 21 • n=99 Participants
|
134 mmHg
STANDARD_DEVIATION 20 • n=107 Participants
|
135 mmHg
STANDARD_DEVIATION 20 • n=206 Participants
|
|
diastolic blood pressure
|
74 mmHg
STANDARD_DEVIATION 11 • n=99 Participants
|
73 mmHg
STANDARD_DEVIATION 10 • n=107 Participants
|
73 mmHg
STANDARD_DEVIATION 10 • n=206 Participants
|
|
phosphorus
|
3.7 mg/dL
STANDARD_DEVIATION 0.5 • n=99 Participants
|
3.9 mg/dL
STANDARD_DEVIATION 0.8 • n=107 Participants
|
3.8 mg/dL
STANDARD_DEVIATION 0.7 • n=206 Participants
|
|
calcium
|
9.3 mg/dL
STANDARD_DEVIATION 0.4 • n=99 Participants
|
9.3 mg/dL
STANDARD_DEVIATION 0.7 • n=107 Participants
|
9.3 mg/dL
STANDARD_DEVIATION 0.6 • n=206 Participants
|
|
estimated glomerular filtration rate
|
33 ml/min/1.73m^2
STANDARD_DEVIATION 12 • n=99 Participants
|
26 ml/min/1.73m^2
STANDARD_DEVIATION 14 • n=107 Participants
|
31 ml/min/1.73m^2
STANDARD_DEVIATION 13 • n=206 Participants
|
|
transferrin saturation
|
18 %
STANDARD_DEVIATION 6 • n=99 Participants
|
19 %
STANDARD_DEVIATION 6 • n=107 Participants
|
18 %
STANDARD_DEVIATION 6 • n=206 Participants
|
|
ferritin
|
90 ng/ml
STANDARD_DEVIATION 70 • n=99 Participants
|
100 ng/ml
STANDARD_DEVIATION 59 • n=107 Participants
|
95 ng/ml
STANDARD_DEVIATION 65 • n=206 Participants
|
|
hemoglobin
|
11.4 g/dL
STANDARD_DEVIATION 1 • n=99 Participants
|
11.0 g/dL
STANDARD_DEVIATION 1 • n=107 Participants
|
11.2 g/dL
STANDARD_DEVIATION 1 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksThe change in serum ferritin concentrations from the baseline of the study to the 12 week time point.
Outcome measures
| Measure |
Ferric Citrate
n=28 Participants
Participants randomized to the ferric citrate arm will receive 2 grams of ferric citrate three times a day with each meal.
ferric citrate: Participants randomized to the ferric citrate arm will take 2 grams of ferric citrate three times a day with meals.
|
Ferrous Sulfate
n=29 Participants
Participants randomized to the ferrous sulfate arm will receive 325 mg of ferrous sulfate three times a day
ferrous sulfate: Participants randomized to the ferrous sulfate arm will take 325 mg of ferrous sulfate three times a day.
|
|---|---|---|
|
Change in Ferritin From Baseline to End of Treatment
|
60 percentage of change from baseline
Standard Error 17
|
30 percentage of change from baseline
Standard Error 10
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksThe change in serum transferrin saturation from the baseline to the end of treatment
Outcome measures
| Measure |
Ferric Citrate
n=28 Participants
Participants randomized to the ferric citrate arm will receive 2 grams of ferric citrate three times a day with each meal.
ferric citrate: Participants randomized to the ferric citrate arm will take 2 grams of ferric citrate three times a day with meals.
|
Ferrous Sulfate
n=29 Participants
Participants randomized to the ferrous sulfate arm will receive 325 mg of ferrous sulfate three times a day
ferrous sulfate: Participants randomized to the ferrous sulfate arm will take 325 mg of ferrous sulfate three times a day.
|
|---|---|---|
|
Change in Transferrin Saturation From Baseline to End of Treatment
|
40 percentage of change from baseline
Standard Error 17
|
2 percentage of change from baseline
Standard Error 7
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksThe change in hemoglobin concentrations from the baseline visit to the 12-week time point.
Outcome measures
| Measure |
Ferric Citrate
n=28 Participants
Participants randomized to the ferric citrate arm will receive 2 grams of ferric citrate three times a day with each meal.
ferric citrate: Participants randomized to the ferric citrate arm will take 2 grams of ferric citrate three times a day with meals.
|
Ferrous Sulfate
n=29 Participants
Participants randomized to the ferrous sulfate arm will receive 325 mg of ferrous sulfate three times a day
ferrous sulfate: Participants randomized to the ferrous sulfate arm will take 325 mg of ferrous sulfate three times a day.
|
|---|---|---|
|
Change in Hemoglobin From Baseline to End of Treatment
|
4 percentage of change from baseline
Standard Error 0.1
|
0 percentage of change from baseline
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksThe change in hepcidin concentrations from the baseline visit to the 12-week time point.
Outcome measures
| Measure |
Ferric Citrate
n=20 Participants
Participants randomized to the ferric citrate arm will receive 2 grams of ferric citrate three times a day with each meal.
ferric citrate: Participants randomized to the ferric citrate arm will take 2 grams of ferric citrate three times a day with meals.
|
Ferrous Sulfate
n=20 Participants
Participants randomized to the ferrous sulfate arm will receive 325 mg of ferrous sulfate three times a day
ferrous sulfate: Participants randomized to the ferrous sulfate arm will take 325 mg of ferrous sulfate three times a day.
|
|---|---|---|
|
Change in Hepcidin From Baseline to the End of Treatment
|
98 percentage of change from baseline
Standard Error 20
|
28 percentage of change from baseline
Standard Error 11
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksThe change in fibroblast growth factor 23 concentrations from the baseline visit to the 12-week time point.
Outcome measures
| Measure |
Ferric Citrate
n=28 Participants
Participants randomized to the ferric citrate arm will receive 2 grams of ferric citrate three times a day with each meal.
ferric citrate: Participants randomized to the ferric citrate arm will take 2 grams of ferric citrate three times a day with meals.
|
Ferrous Sulfate
n=29 Participants
Participants randomized to the ferrous sulfate arm will receive 325 mg of ferrous sulfate three times a day
ferrous sulfate: Participants randomized to the ferrous sulfate arm will take 325 mg of ferrous sulfate three times a day.
|
|---|---|---|
|
Change in Fibroblast Growth Factor 23 From Baseline to the End of Treatment
|
-37 pg/ml
Interval -74.0 to 1.0
|
-8 pg/ml
Interval -32.0 to 16.0
|
Adverse Events
Ferric Citrate
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Ferrous Sulfate
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ferric Citrate
n=30 participants at risk
Participants randomized to the ferric citrate arm will receive 2 grams of ferric citrate three times a day with each meal.
ferric citrate: Participants randomized to the ferric citrate arm will take 2 grams of ferric citrate three times a day with meals.
|
Ferrous Sulfate
n=30 participants at risk
Participants randomized to the ferrous sulfate arm will receive 325 mg of ferrous sulfate three times a day
ferrous sulfate: Participants randomized to the ferrous sulfate arm will take 325 mg of ferrous sulfate three times a day.
|
|---|---|---|
|
Gastrointestinal disorders
Change in stool color
|
53.3%
16/30 • Number of events 16 • 3 months
|
26.7%
8/30 • Number of events 8 • 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
9/30 • Number of events 9 • 3 months
|
16.7%
5/30 • Number of events 5 • 3 months
|
|
Gastrointestinal disorders
Constipation
|
30.0%
9/30 • Number of events 9 • 3 months
|
36.7%
11/30 • Number of events 11 • 3 months
|
|
Gastrointestinal disorders
Anorexia
|
6.7%
2/30 • Number of events 2 • 3 months
|
26.7%
8/30 • Number of events 8 • 3 months
|
|
General disorders
Weight Loss
|
10.0%
3/30 • Number of events 3 • 3 months
|
23.3%
7/30 • Number of events 7 • 3 months
|
|
General disorders
Weight gain
|
16.7%
5/30 • Number of events 5 • 3 months
|
26.7%
8/30 • Number of events 8 • 3 months
|
|
General disorders
Fatigue
|
20.0%
6/30 • Number of events 6 • 3 months
|
10.0%
3/30 • Number of events 3 • 3 months
|
|
Infections and infestations
Infection
|
16.7%
5/30 • Number of events 5 • 3 months
|
3.3%
1/30 • Number of events 1 • 3 months
|
|
Eye disorders
Eye pain
|
6.7%
2/30 • Number of events 2 • 3 months
|
16.7%
5/30 • Number of events 5 • 3 months
|
|
Eye disorders
Vision changes
|
13.3%
4/30 • Number of events 4 • 3 months
|
13.3%
4/30 • Number of events 4 • 3 months
|
|
Ear and labyrinth disorders
Nasal congestion
|
10.0%
3/30 • Number of events 3 • 3 months
|
13.3%
4/30 • Number of events 4 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
2/30 • Number of events 2 • 3 months
|
16.7%
5/30 • Number of events 5 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
3/30 • Number of events 3 • 3 months
|
3.3%
1/30 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
20.0%
6/30 • Number of events 6 • 3 months
|
16.7%
5/30 • Number of events 5 • 3 months
|
|
Gastrointestinal disorders
GERD
|
10.0%
3/30 • Number of events 3 • 3 months
|
3.3%
1/30 • Number of events 1 • 3 months
|
|
Renal and urinary disorders
Urinary frequency
|
6.7%
2/30 • Number of events 2 • 3 months
|
16.7%
5/30 • Number of events 5 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
3/30 • Number of events 3 • 3 months
|
6.7%
2/30 • Number of events 2 • 3 months
|
|
Blood and lymphatic system disorders
edema
|
0.00%
0/30 • 3 months
|
13.3%
4/30 • Number of events 4 • 3 months
|
|
General disorders
Headache
|
6.7%
2/30 • Number of events 2 • 3 months
|
20.0%
6/30 • Number of events 6 • 3 months
|
|
Ear and labyrinth disorders
change in smell
|
10.0%
3/30 • Number of events 3 • 3 months
|
6.7%
2/30 • Number of events 2 • 3 months
|
Additional Information
Orlando M. Gutierrez, MD
University of Alabama at Birmingham
Phone: 205-996-2736
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place