Trial Outcomes & Findings for Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure (NCT NCT01925703)

NCT ID: NCT01925703

Last Updated: 2015-08-25

Results Overview

Change in serum hemoglobin concentration compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

13 participants

Primary outcome timeframe

Baseline and at follow-up within 1-4 weeks

Results posted on

2015-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	Sodium Ferric Gluconate Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
Overall Study STARTED	13
Overall Study Dosing Regimen Completed	12
Overall Study Full Iron Repletion Achieved	11
Overall Study Follow-up Completed	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Sodium Ferric Gluconate Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
Overall Study Physician Decision	1
Overall Study Lost to Follow-up	2
Overall Study Discharge prior to full iron repletion	1

Baseline Characteristics

Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sodium Ferric Gluconate n=13 Participants Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
Age, Continuous	58.9 years STANDARD_DEVIATION 12.8 • n=99 Participants
Sex: Female, Male Female	6 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	8 Participants n=99 Participants
Race (NIH/OMB) White	5 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	13 participants n=99 Participants
Weight	94.9 kilograms STANDARD_DEVIATION 25 • n=99 Participants
Body Mass Index	33.9 kilograms per meter squared STANDARD_DEVIATION 9.5 • n=99 Participants
NYHA Heart Failure Class Class I	0 participants n=99 Participants
NYHA Heart Failure Class Class II	0 participants n=99 Participants
NYHA Heart Failure Class Class III	7 participants n=99 Participants
NYHA Heart Failure Class Class IV	6 participants n=99 Participants
Ejection Fraction	20.2 percent STANDARD_DEVIATION 8.4 • n=99 Participants
Hemoglobin Concentration	10.6 grams per deciliter STANDARD_DEVIATION 1.4 • n=99 Participants
Ferritin Concentration	86.4 nanograms per milliliter STANDARD_DEVIATION 61.4 • n=99 Participants
Transferrin Saturation	11.7 percentage of transferrin saturation STANDARD_DEVIATION 4.6 • n=99 Participants
Serum Creatinine Concentration	1.2 milligrams per deciliter STANDARD_DEVIATION 0.4 • n=99 Participants

PRIMARY outcome

Timeframe: Baseline and at follow-up within 1-4 weeks

Population: All patients who achieved complete iron repletion for whom follow up data were available.

Change in serum hemoglobin concentration compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion

Outcome measures

Outcome measures
Measure	Sodium Ferric Gluconate n=9 Participants Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
Serum Hemoglobin Concentration	1.2 grams per deciliter Interval 0.45 to 1.9

SECONDARY outcome

Timeframe: Baseline and at follow-up within 1-4 weeks

Population: All patients who achieved complete iron repletion for whom follow-up data were available.

Change in transferrin saturation compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion

Outcome measures

Outcome measures
Measure	Sodium Ferric Gluconate n=9 Participants Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
Transferrin Saturation	10.5 Percentage of transferrin saturation Interval 6.5 to 14.6

SECONDARY outcome

Timeframe: Baseline and at follow-up within 1-4 weeks

Population: All participants who achieved complete iron repletion for whom follow up data were available.

Change in serum ferritin level compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion

Outcome measures

Outcome measures
Measure	Sodium Ferric Gluconate n=9 Participants Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
Serum Ferritin Level	364.2 nanograms per milliliter Interval 129.7 to 598.7

Adverse Events

Sodium Ferric Gluconate

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sodium Ferric Gluconate n=13 participants at risk Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
General disorders Clinical Deterioration	7.7% 1/13 • Number of events 1

Other adverse events

Other adverse events
Measure	Sodium Ferric Gluconate n=13 participants at risk Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
Gastrointestinal disorders nausea	23.1% 3/13 • Number of events 6
Gastrointestinal disorders constipation	7.7% 1/13 • Number of events 1
Gastrointestinal disorders abdominal discomfort	23.1% 3/13 • Number of events 5
Gastrointestinal disorders diarrhea	23.1% 3/13 • Number of events 4
Skin and subcutaneous tissue disorders injection site itching	23.1% 3/13 • Number of events 3
Skin and subcutaneous tissue disorders injection site discomfort	23.1% 3/13 • Number of events 4
Vascular disorders thrombophlebitis	7.7% 1/13 • Number of events 1
Skin and subcutaneous tissue disorders cellulitis	7.7% 1/13 • Number of events 1
Nervous system disorders headache	15.4% 2/13 • Number of events 2
Respiratory, thoracic and mediastinal disorders dyspnea	7.7% 1/13 • Number of events 1
Musculoskeletal and connective tissue disorders back pain	7.7% 1/13 • Number of events 1
Musculoskeletal and connective tissue disorders leg cramps	7.7% 1/13 • Number of events 1
Renal and urinary disorders bladder discomfort	7.7% 1/13 • Number of events 1
General disorders fatigue	7.7% 1/13 • Number of events 1
General disorders chills	7.7% 1/13 • Number of events 1
Gastrointestinal disorders melena	7.7% 1/13 • Number of events 1
Renal and urinary disorders hematuria	7.7% 1/13 • Number of events 2

Additional Information

Dr. Brent N. Reed

University of Maryland School of Pharmacy, Department of Pharmacy Practice and Science

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place