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

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ClinicalTrials.gov Identifier: NCT01925703
Recruitment Status : Completed
First Posted : August 20, 2013
Results First Posted : August 10, 2015
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Heart Failure
Iron Deficiency Anemia
Intervention Drug: Sodium ferric gluconate
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sodium Ferric Gluconate
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 13
Dosing Regimen Completed 12
Full Iron Repletion Achieved 11
Follow-up Completed 9
Completed 9
Not Completed 4
Reason Not Completed
Physician Decision             1
Lost to Follow-up             2
Discharge prior to full iron repletion             1
Arm/Group Title Sodium Ferric Gluconate
Hide Arm/Group Description 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 Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
58.9  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
6
  46.2%
Male
7
  53.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
  61.5%
White
5
  38.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 13 participants
94.9  (25)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilograms per meter squared
Number Analyzed 13 participants
33.9  (9.5)
NYHA Heart Failure Class  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants
Class I 0
Class II 0
Class III 7
Class IV 6
Ejection Fraction  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 13 participants
20.2  (8.4)
Hemoglobin Concentration  
Mean (Standard Deviation)
Unit of measure:  Grams per deciliter
Number Analyzed 13 participants
10.6  (1.4)
Ferritin Concentration  
Mean (Standard Deviation)
Unit of measure:  Nanograms per milliliter
Number Analyzed 13 participants
86.4  (61.4)
Transferrin Saturation  
Mean (Standard Deviation)
Unit of measure:  Percentage of transferrin saturation
Number Analyzed 13 participants
11.7  (4.6)
Serum Creatinine Concentration  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter
Number Analyzed 13 participants
1.2  (0.4)
1.Primary Outcome
Title Serum Hemoglobin Concentration
Hide Description Change in serum hemoglobin concentration compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion
Time Frame Baseline and at follow-up within 1-4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who achieved complete iron repletion for whom follow up data were available.
Arm/Group Title Sodium Ferric Gluconate
Hide Arm/Group Description:
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 Number of Participants Analyzed 9
Mean (95% Confidence Interval)
Unit of Measure: grams per deciliter
1.2
(0.45 to 1.9)
2.Secondary Outcome
Title Transferrin Saturation
Hide Description Change in transferrin saturation compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion
Time Frame Baseline and at follow-up within 1-4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who achieved complete iron repletion for whom follow-up data were available.
Arm/Group Title Sodium Ferric Gluconate
Hide Arm/Group Description:
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 Number of Participants Analyzed 9
Mean (95% Confidence Interval)
Unit of Measure: Percentage of transferrin saturation
10.5
(6.5 to 14.6)
3.Secondary Outcome
Title Serum Ferritin Level
Hide Description Change in serum ferritin level compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion
Time Frame Baseline and at follow-up within 1-4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who achieved complete iron repletion for whom follow up data were available.
Arm/Group Title Sodium Ferric Gluconate
Hide Arm/Group Description:
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 Number of Participants Analyzed 9
Mean (95% Confidence Interval)
Unit of Measure: nanograms per milliliter
364.2
(129.7 to 598.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sodium Ferric Gluconate
Hide Arm/Group Description 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.
All-Cause Mortality
Sodium Ferric Gluconate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sodium Ferric Gluconate
Affected / at Risk (%) # Events
Total   1/13 (7.69%)    
General disorders   
Clinical Deterioration * [1]  1/13 (7.69%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Patient was withdrawn from study after two of the four study drug doses were administered at the discretion of the treating physician. Reason for withdrawal was clinical deterioration secondary to hypovolemia and aggressive vasodilator titration.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sodium Ferric Gluconate
Affected / at Risk (%) # Events
Total   11/13 (84.62%)    
Gastrointestinal disorders   
nausea *  3/13 (23.08%)  6
constipation *  1/13 (7.69%)  1
abdominal discomfort *  3/13 (23.08%)  5
diarrhea *  3/13 (23.08%)  4
melena *  1/13 (7.69%)  1
General disorders   
fatigue *  1/13 (7.69%)  1
chills *  1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders   
back pain *  1/13 (7.69%)  1
leg cramps *  1/13 (7.69%)  1
Nervous system disorders   
headache *  2/13 (15.38%)  2
Renal and urinary disorders   
bladder discomfort *  1/13 (7.69%)  1
hematuria *  1/13 (7.69%)  2
Respiratory, thoracic and mediastinal disorders   
dyspnea *  1/13 (7.69%)  1
Skin and subcutaneous tissue disorders   
injection site itching *  3/13 (23.08%)  3
injection site discomfort *  3/13 (23.08%)  4
cellulitis *  1/13 (7.69%)  1
Vascular disorders   
thrombophlebitis *  1/13 (7.69%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Brent N. Reed
Organization: University of Maryland School of Pharmacy, Department of Pharmacy Practice and Science
EMail: breed@rx.umaryland.edu
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01925703     History of Changes
Other Study ID Numbers: 11-0551
First Submitted: May 30, 2013
First Posted: August 20, 2013
Results First Submitted: June 9, 2015
Results First Posted: August 10, 2015
Last Update Posted: August 25, 2015