Trial Outcomes & Findings for Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding (NCT NCT01307007)
NCT ID: NCT01307007
Last Updated: 2018-02-19
Results Overview
Changes in blood markers of phosphate
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
Day 35
Results posted on
2018-02-19
Participant Flow
Hospitals and medical clinics
In the FCM group, reasons for discontinuation prior to dosing included lost to follow-up (5 subjects), subject request (2 subjects), and selection criteria/study compliance (2 subjects). In the iron dextran group, reasons for discontinuation prior to dosing included subject request (4 subjects) and lost to follow-up (1 subject).
Participant milestones
| Measure |
Ferric Carboxymaltose (FCM)
Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
|
Iron Dextran Injection
Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
30
|
|
Overall Study
COMPLETED
|
25
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding
Baseline characteristics by cohort
| Measure |
Ferric Carboxymaltose (FCM)
n=25 Participants
Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
|
Iron Dextran Injection
n=30 Participants
Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
36.8 years
STANDARD_DEVIATION 10.26 • n=99 Participants
|
33.7 years
STANDARD_DEVIATION 10.72 • n=107 Participants
|
35.1 years
STANDARD_DEVIATION 10.54 • n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
30 participants
n=107 Participants
|
55 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 35Changes in blood markers of phosphate
Outcome measures
| Measure |
Ferric Carboxymaltose (FCM)
n=21 Participants
Ferric Carboxymaltose (FCM): 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
|
Iron Dextran Injection
n=26 Participants
Iron Dextran Injection: Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
|
|---|---|---|
|
Changes in Blood Markers
|
-.38 mg/dL
Standard Deviation .878
|
-.08 mg/dL
Standard Deviation .633
|
Adverse Events
Ferric Carboxymaltose (FCM)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Iron Dextran Injection
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=25 participants at risk
Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
|
Iron Dextran Injection
n=30 participants at risk
Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • 8 months
|
6.7%
2/30 • 8 months
|
|
General disorders
Edema peripheral
|
0.00%
0/25 • 8 months
|
6.7%
2/30 • 8 months
|
|
Immune system disorders
Hypersensitivity
|
8.0%
2/25 • 8 months
|
3.3%
1/30 • 8 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/25 • 8 months
|
6.7%
2/30 • 8 months
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • 8 months
|
6.7%
2/30 • 8 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
32.0%
8/25 • 8 months
|
3.3%
1/30 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25 • 8 months
|
6.7%
2/30 • 8 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/25 • 8 months
|
6.7%
2/30 • 8 months
|
Additional Information
Sumita Chowdhury, MD, MPH, FACC, MBA
Luitpold Pharmaceuticals, Inc.
Phone: 610-650-4200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60