Iron Sucrose for Anemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Wisconsin Carbone Cancer Center, Madison, WIAnemia+2 MoreIron Sucrose - Other
Eligibility
18+
Female
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Study Summary

This trial will test whether IV infusions of iron sucrose can improve iron stores in ovarian cancer patients before surgery, and reduce the need for transfusions of packed red blood cells during surgery.

Eligible Conditions
  • Anemia
  • Iron-Deficiency Anemia
  • Ovarian Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Within 72 hours of surgery, up to 5 weeks on study

Week 5
Rate of Peri-operative Blood Transfusion
Day 21
Incidence of Treatment Emergent Adverse Events (AEs)
Rate of Iron Deficiency Anemia
Rate of Resolution of Iron Deficiency Anemia After Intervention

Trial Safety

Side Effects for

Ferumoxytol
38%Gastrointestinal disorders
33%Infections and infestations
31%Injury, poisoning and procedural complications
29%General disorders and administration site conditions
21%Respiratory, thoracic and mediastinal disorders
20%Musculoskeletal and connective tissue disorders
19%Vascular disorders
18%Nervous system disorders
16%Metabolism and nutrition disorders
15%Cardiac disorders
11%Nausea
11%Diarrhoea
10%Skin and subcutaneous tissue disorders
9%Hypotension
9%Psychiatric disorders
8%Vomiting
8%Muscle spasms
8%Pyrexia
7%Fluid overload
7%Arteriovenous fistula site complication
7%Pain in extremity
7%Blood and lymphatic system disorders
7%Upper respiratory tract infection
7%Hypertension
6%Cough
6%Abdominal pain
6%Investigations
6%Urinary tract infection
6%Pruritus
6%Dyspnoea
6%Pneumonia
6%Hyperkalaemia
5%Sepsis
5%Non-cardiac chest pain
5%Dizziness
4%Headache
4%Acute respiratory failure
4%Arthralgia
4%Anaemia
4%Fall
4%Arteriovenous fistula thrombosis
3%Cardiac failure congestive
3%Mental status changes
3%Pulmonary oedema
3%Cellulitis
2%Gastrointestinal haemorrhage
2%Acute myocardial infarction
2%Angina pectoris
2%Cardiac arrest
2%Hip fracture
2%Pleural effusion
2%Cardio-respiratory arrest
1%Hypoglycaemia
1%Neoplasms benign, malignant and unspecified (incl cysts and polyps)
1%Immune system disorders
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT01227616) in the Ferumoxytol ARM group. Side effects include: Gastrointestinal disorders with 38%, Infections and infestations with 33%, Injury, poisoning and procedural complications with 31%, General disorders and administration site conditions with 29%, Respiratory, thoracic and mediastinal disorders with 21%.

Trial Design

1 Treatment Group

IV Iron Sucrose
1 of 1

Experimental Treatment

9 Total Participants · 1 Treatment Group

Primary Treatment: Iron Sucrose · No Placebo Group · Phase 1 & 2

IV Iron Sucrose
Other
Experimental Group · 1 Intervention: Iron Sucrose · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within 72 hours of surgery, up to 5 weeks on study

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,077 Previous Clinical Trials
2,582,243 Total Patients Enrolled
Lisa Barroilhet, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

Eligibility Criteria

Age 18+ · Female Participants · 9 Total Inclusion Criteria

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Frequently Asked Questions

Are there still positions open for participants in this trial?

"That's right, the listing on clinicaltrials.gov currently says that this study is recruiting patients. This particular trial was first advertised on 7/29/2019, and the most recent update was on 10/5/2022. They are hoping to find 21 volunteers for the 1 site location." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.