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

NCT01925703 | Completed Phase 4 Results

• 1 other identifier: 11-0551
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Intravenous iron replacement has been shown to benefit patients with heart failure and iron deficiency, but the weekly outpatient regimens studied to date are impractical for many patients. Our purpose is to evaluate the short-term effects and safety of an accelerated intravenous iron regimen in hospitalized patients with these two conditions.

Conditions

Heart Failure; Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Serum Hemoglobin Concentration

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

  Baseline and at follow-up within 1-4 weeks

Secondary Outcomes (2)

• Transferrin Saturation

  Baseline and at follow-up within 1-4 weeks

• Serum Ferritin Level

  Baseline and at follow-up within 1-4 weeks

Study Arms (1)

Sodium ferric gluconate

EXPERIMENTAL

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.

Drug: Sodium ferric gluconate

Interventions

Sodium ferric gluconate DRUG

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.

Also known as: Ferrlecit

Sodium ferric gluconate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Admission to the general cardiology or heart failure services and under the care of a cardiologist at the study institution
• New York Heart Association Class II-IV heart failure
• Ejection fraction \< 40%
• Serum hemoglobin \< 12.0 g/dL
• Ferritin \< 100 ng/mL or 100-300 ng/mL with transferrin saturation (TSAT) \< 20%
• Patients deemed by an attending physician to require intravenous iron therapy based on previous attempts to correct iron deficiency or other patient-specific circumstances

You may not qualify if:

• Anemia of other known etiology (e.g., malignancy, malabsorption syndromes)
• Use of iron or erythropoietin-stimulating agents within previous 12 weeks
• Blood transfusion within previous 12 weeks; additionally, if patients receive blood transfusions during the study period, they will remain in the safety analysis but will be excluded from efficacy analysis
• Active bleeding
• Known infection at admission
• Immunosuppressant therapy
• Renal replacement therapy
• Known pregnancy

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina Hospitals & Clinics

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Heart Failure; Anemia, Iron-Deficiency

Interventions

ferric gluconate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. Brent N. Reed
• Organization: University of Maryland School of Pharmacy, Department of Pharmacy Practice and Science

breed@rx.umaryland.edu

Study Officials

• Jo Ellen Rodgers, PharmD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: August 20, 2013
• Study Start: April 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 25, 2015
• Results First Posted: August 10, 2015

Record last verified: 2014-05

Locations

US (1)