Trial Outcomes & Findings for IV Iron Safety: Evaluation of Iron Species in Healthy Subjects (NCT NCT02399449)
NCT ID: NCT02399449
Last Updated: 2022-09-28
Results Overview
area under curve of non-transferrin bound iron. Non-transferrin bound iron is the difference between plasma total iron and transferrin bound iron, both of which were directly quantified. Units are concentration x time (i.e. ppb x hr).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
110 participants
Primary outcome timeframe
0-36 hr
Results posted on
2022-09-28
Participant Flow
Enrollment number is the number of participants who signed a consent form, per local IRB requirements.
Participant milestones
| Measure |
Brand Sodium Ferric Gluconate Then Generic Sodium Ferric Gluconate
Crossover trial. Each arm will receive Brand sodium ferric gluconate then Generic sodium ferric gluconate
Brand sodium ferric gluconate: brand product
Generic sodium ferric gluconate: generic product
|
Generic Sodium Ferric Gluconate Then Brand Sodium Ferric Gluconate
Crossover trial. Each arm will receive Generic sodium ferric gluconate then Brand sodium ferric gluconate
Brand sodium ferric gluconate: brand product
Generic sodium ferric gluconate: generic product
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
32
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
10
|
Reasons for withdrawal
| Measure |
Brand Sodium Ferric Gluconate Then Generic Sodium Ferric Gluconate
Crossover trial. Each arm will receive Brand sodium ferric gluconate then Generic sodium ferric gluconate
Brand sodium ferric gluconate: brand product
Generic sodium ferric gluconate: generic product
|
Generic Sodium Ferric Gluconate Then Brand Sodium Ferric Gluconate
Crossover trial. Each arm will receive Generic sodium ferric gluconate then Brand sodium ferric gluconate
Brand sodium ferric gluconate: brand product
Generic sodium ferric gluconate: generic product
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
9
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
IV Iron Safety: Evaluation of Iron Species in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Brand Sodium Ferric Gluconate Then Generic Sodium Ferric Gluconate
n=25 Participants
Crossover trial. Each arm will receive Brand sodium ferric gluconate then Generic sodium ferric gluconate
Brand sodium ferric gluconate: brand product
Generic sodium ferric gluconate: generic product
|
Generic Sodium Ferric Gluconate Then Brand Sodium Ferric Gluconate
n=24 Participants
Crossover trial. Each arm will receive Generic sodium ferric gluconate then Brand sodium ferric gluconate
Brand sodium ferric gluconate: brand product
Generic sodium ferric gluconate: generic product
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34 years
n=5 Participants
|
36 years
n=7 Participants
|
35 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-36 hrarea under curve of non-transferrin bound iron. Non-transferrin bound iron is the difference between plasma total iron and transferrin bound iron, both of which were directly quantified. Units are concentration x time (i.e. ppb x hr).
Outcome measures
| Measure |
Brand Sodium Ferric Gluconate
n=35 Participants
brand product
|
Generic Sodium Ferric Gluconate
n=35 Participants
generic product
|
|---|---|---|
|
Non-transferrin Bound Iron
|
56230 ppb x hours
Standard Error 2910
|
61250 ppb x hours
Standard Error 3410
|
SECONDARY outcome
Timeframe: 0-36 hrarea under curve of plasma total iron. Units are concentration x time (i.e. ppb x hr).
Outcome measures
| Measure |
Brand Sodium Ferric Gluconate
n=35 Participants
brand product
|
Generic Sodium Ferric Gluconate
n=35 Participants
generic product
|
|---|---|---|
|
Plasma Total Iron
|
132800 ppb x hours
Standard Error 4700
|
134700 ppb x hours
Standard Error 5100
|
SECONDARY outcome
Timeframe: 0-36 hrarea under curve of transferrin bound iron. Units are concentration x time (i.e. ppb x hr).
Outcome measures
| Measure |
Brand Sodium Ferric Gluconate
n=35 Participants
brand product
|
Generic Sodium Ferric Gluconate
n=35 Participants
generic product
|
|---|---|---|
|
Transferrin Bound Iron
|
96760 ppb x hours
Standard Error 3680
|
91740 ppb x hours
Standard Error 3980
|
Adverse Events
Brand Sodium Ferric Gluconate
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Generic Sodium Ferric Gluconate
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brand Sodium Ferric Gluconate
n=47 participants at risk
brand product
|
Generic Sodium Ferric Gluconate
n=46 participants at risk
generic product
|
|---|---|---|
|
Vascular disorders
hypotension
|
2.1%
1/47 • Number of events 1 • About 1 month
|
0.00%
0/46 • About 1 month
|
Other adverse events
| Measure |
Brand Sodium Ferric Gluconate
n=47 participants at risk
brand product
|
Generic Sodium Ferric Gluconate
n=46 participants at risk
generic product
|
|---|---|---|
|
General disorders
Abdominal Cramping
|
6.4%
3/47 • Number of events 3 • About 1 month
|
0.00%
0/46 • About 1 month
|
|
Vascular disorders
Hypotension
|
6.4%
3/47 • Number of events 3 • About 1 month
|
0.00%
0/46 • About 1 month
|
|
Nervous system disorders
Dizziness
|
8.5%
4/47 • Number of events 4 • About 1 month
|
0.00%
0/46 • About 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
2/47 • Number of events 2 • About 1 month
|
0.00%
0/46 • About 1 month
|
|
General disorders
Leg Swelling
|
2.1%
1/47 • Number of events 1 • About 1 month
|
0.00%
0/46 • About 1 month
|
|
General disorders
Lower Back Pain
|
14.9%
7/47 • Number of events 7 • About 1 month
|
0.00%
0/46 • About 1 month
|
|
Cardiac disorders
Bradycardia
|
2.1%
1/47 • Number of events 1 • About 1 month
|
0.00%
0/46 • About 1 month
|
|
Skin and subcutaneous tissue disorders
Infusion Site Irritation
|
0.00%
0/47 • About 1 month
|
4.3%
2/46 • Number of events 2 • About 1 month
|
|
General disorders
Facial Flushing
|
2.1%
1/47 • Number of events 1 • About 1 month
|
0.00%
0/46 • About 1 month
|
|
General disorders
Infusion Site Pain
|
0.00%
0/47 • About 1 month
|
2.2%
1/46 • Number of events 1 • About 1 month
|
|
General disorders
Infusion Site-To -Hand Swelling
|
2.1%
1/47 • Number of events 1 • About 1 month
|
0.00%
0/46 • About 1 month
|
|
Nervous system disorders
Syncope
|
2.1%
1/47 • Number of events 1 • About 1 month
|
0.00%
0/46 • About 1 month
|
|
Musculoskeletal and connective tissue disorders
Finger Cramping
|
2.1%
1/47 • Number of events 1 • About 1 month
|
0.00%
0/46 • About 1 month
|
|
General disorders
Nausea
|
2.1%
1/47 • Number of events 1 • About 1 month
|
0.00%
0/46 • About 1 month
|
|
General disorders
Hand Swelling
|
4.3%
2/47 • Number of events 2 • About 1 month
|
0.00%
0/46 • About 1 month
|
|
Musculoskeletal and connective tissue disorders
Hand Muscle Stiffness
|
4.3%
2/47 • Number of events 2 • About 1 month
|
0.00%
0/46 • About 1 month
|
|
Cardiac disorders
Tachycardia
|
2.1%
1/47 • Number of events 1 • About 1 month
|
0.00%
0/46 • About 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place