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IV Iron Replacement for Anemia (Iron-RANC Trial)
Phase 2
Recruiting
Led By Iberia Sosa, MD
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Iron-RANC Trial Summary
This trial tests if IV iron can help patients with cancer before surgery to increase their chances of successful treatment.
Who is the study for?
This trial is for adults over 18 with anemia (Hgb <10.5 g/dL) during chemotherapy, low iron levels, and who are planning surgery after chemo for breast, thoracic, GI or GU cancers. They must understand and sign consent forms. Excluded are those on certain anemia drugs, with uncontrolled illnesses, recent iron infusions, pregnant/breastfeeding women, other causes of anemia or known allergy to Iron sucrose.Check my eligibility
What is being tested?
The study tests the effectiveness of Venofer (intravenous iron sucrose) as a single therapy in reducing anemia for patients undergoing neoadjuvant chemotherapy before surgical cancer treatment. It's open-label at one institution aiming to see if this approach can improve patient outcomes.See study design
What are the potential side effects?
Possible side effects of Venofer may include allergic reactions like itching or rash; muscle cramps; dizziness; changes in blood pressure; nausea or vomiting; headache; joint pain; fever or shivering.
Iron-RANC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change from baseline to highest Hgb value
Secondary outcome measures
Number of transfusions during neo-adjuvant period
Side effects data
From 2004 Phase 3 trial • 182 Patients • NCT002369778%
Oedema peripheral
8%
Dysgeusia
5%
Diarrhea NOS
5%
Constipation
5%
Dizziness
5%
Hypertension NOS
5%
Nausea
4%
Oedema NOS
3%
Fatigue
3%
Vomiting NOS
2%
Fecal Occult Blood Positive
2%
Hypotension NOS
1%
Renal failure acute
1%
Sepsis NOS
1%
Respiratory failure
1%
Fluid Overload
1%
Mental status changes
1%
Pleural effusion
1%
Intraoperative haemorrhage
1%
Lobar pneumonia NOS
1%
Urinary Tract Infection NOS
1%
Hyponatraemia
1%
Angina pectoris
1%
Dyspnea
1%
Flank pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Venofer
Ferrous Sulfate
Iron-RANC Trial Design
1Treatment groups
Experimental Treatment
Group I: Venofer treatmentExperimental Treatment1 Intervention
Venofer (iron-sucrose) 200mg (5 days) every week administered as an IV infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venofer
2003
Completed Phase 4
~290
Find a Location
Who is running the clinical trial?
Fox Chase Cancer CenterLead Sponsor
228 Previous Clinical Trials
37,596 Total Patients Enrolled
Iberia Sosa, MDPrincipal InvestigatorFox Chase Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.I do not have an infection that affects my whole body.I am receiving treatment before surgery for cancer in my breast, chest, stomach area, or urinary system.My hemoglobin level is below 10.5 g/dL during chemotherapy.I have received an iron infusion in the last 4 weeks.My anemia is caused by a condition like MDS or Myeloma.I have anemia with Hgb below 11.0 g/dL and no severe ongoing illnesses.I haven't used erythropoietin stimulating agents in the last 4 weeks, unless for chronic kidney disease.
Research Study Groups:
This trial has the following groups:- Group 1: Venofer treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are enrolled in this research project?
"Affirmative. Data located on clinicaltrials.gov substantiates that this medical investigation, which was initially posted on March 15th 2023, is currently enlisting. Approximately 34 participants need to be enrolled from 1 exclusive site."
Answered by AI
Is there still room for participants in this research endeavor?
"According to the clinicaltrials.gov listing, this medical research is presently recruiting volunteers. This trial was first announced on March 15th 2023 and had its most recent update posted a week later, on March 24th of the same year."
Answered by AI
Is there potential for adverse effects when treating with Venofer?
"Venofer treatment received a rating of 2, as it has been demonstrated to be safe through Phase 2 trial evidence; however, efficacy remains unproven."
Answered by AI
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