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Iron Supplement

Ferric Carboxymaltose for Iron-Deficiency Anemia

Phase 2
Waitlist Available
Led By Stuart Katz, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptomatic NYHA Class II-III heart failure >3 months
Guideline-recommended heart failure treatment for > 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4
Awards & highlights

Study Summary

This trial will test whether iron supplementation can improve exercise ability in heart failure patients.

Eligible Conditions
  • Iron-Deficiency Anemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Post-Exercise Phosphocreatine Recovery Time
Secondary outcome measures
Change From Baseline in 6-Minute Walk Test Distance
Change From Baseline in Hemoglobin Levels
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Score
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ferric CarboxymaltoseExperimental Treatment2 Interventions
HF patients with functional iron deficiency assigned to receive one-time dose of Ferric Carboxymaltose 750 mg. Participants will undergo serial assessment before and 4 weeks after study drug administration
Group II: PlaceboActive Control2 Interventions
HF patients with functional iron deficiency assigned to receive one-time dose of Placebo (saline injection). Participants will undergo serial assessment before and 4 weeks after study drug administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferric Carboxymaltose
2016
Completed Phase 4
~6770

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,361 Previous Clinical Trials
817,744 Total Patients Enrolled
Stuart Katz, MDPrincipal InvestigatorNYU Langone Health
9 Previous Clinical Trials
938 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the uppermost limit of participants enrolled in this clinical research?

"Indeed, the information found on clinicaltrials.gov implies that this research is still open for enrollment. It was posted on September 7th 2017 and last updated on February 2nd 2022 with a requirement of 32 participants from 1 site."

Answered by AI

Does this research encompass participants aged 30 and over?

"The present clinical study is only open to patients between 21 and 75 years of age. There are 45 trials accommodating those under 18, while 733 studies focus on individuals over the age of 65."

Answered by AI

What population is eligible to participate in this experiment?

"This medical study has the capacity to enrol 32 individuals between 21-75 suffering from heart failure. Furthermore, they must meet certain criteria such as a left ventricular ejection fraction below 40%, NYHA Class II-III symptoms persisting for at least 3 months and functional iron deficiency (defined as serum ferritin level <100 ng/ml or between 100 and 299 ng/ml with transferrin saturation <20%). Additionally, they also need to be willing to provide written informed consent."

Answered by AI

Have other clinical trials employed Ferric Carboxymaltose in the past?

"Currently, 21 clinical trials are in progress that analyze the efficacy of Ferric Carboxymaltose. Of those studies, 6 have reached Phase 3 and they span 398 medical sites all over Kano and Lagos."

Answered by AI

Is enrollment for this clinical trial still available?

"Affirmative. The records on clinicaltrials.gov reveal that this experiment is in the process of recruiting patients, with 32 subjects needed to be enrolled from 1 site. It was first published on September 7th 2017 and most recently updated on February 2nd 2022."

Answered by AI

How hazardous is Ferric Carboxymaltose to individuals?

"Ferric Carboxymaltose has been evaluated in Phase 2 trials, providing the team at Power with enough data to give it a safety score of two. Unfortunately, there is not yet any evidence for its efficacy."

Answered by AI

What medical ailments is Ferric Carboxymaltose utilized to combat?

"Ferric Carboxymaltose is routinely employed to address iron deficiency, and it has also been known to successfully treat conditions such as oral cavity problems, anemia due to breast feeding."

Answered by AI
~3 spots leftby Mar 2025