BridgeMD
New treatment option for Anemia
Official title Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy
ClinicalTrials.gov ID: NCT05800600
What this study is testing
What is Venofer?
Venofer is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female patients \> 18 years
- Patients undergoing neoadjuvant chemotherapy, including radiation and/or immunotherapy, with intent for curative surgical resection for breast...
- Anemia defined as Hgb \<10.5 g/dL during chemotherapy.
- Iron storage levels of ferritin \<500 ng/mL and iron saturation \<35%
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document
You likely can't join if
- Diagnosis of anemia at the time of cycle 1 day 1 of neoadjuvant chemotherapy, Hgb \< 11.0 g/dL, uncontrolled intercurrent illness including, but not...
- Prior parenteral iron infusion in the past 4 weeks
- The use of erythropoietin stimulating agents within 4 weeks unless chronic needs due to CKD
- Concurrent systemic infection at the time of enrollment.
- Known hypersensitivity to Iron sucrose
- Pregnant or breast feeding. Refer to section 4.4 for further detail.
See the full eligibility criteria
- Male or female patients \> 18 years
- Patients undergoing neoadjuvant chemotherapy, including radiation and/or immunotherapy, with intent for curative surgical resection for breast, thoracic, gastrointestinal (GI) or genitourinary (GU) malignancies.
- Anemia defined as Hgb \<10.5 g/dL during chemotherapy.
- Iron storage levels of ferritin \<500 ng/mL and iron saturation \<35%
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document
- Diagnosis of anemia at the time of cycle 1 day 1 of neoadjuvant chemotherapy, Hgb \< 11.0 g/dL, uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic new/exacerbated...
- Prior parenteral iron infusion in the past 4 weeks
- The use of erythropoietin stimulating agents within 4 weeks unless chronic needs due to CKD
- Concurrent systemic infection at the time of enrollment.
- Known hypersensitivity to Iron sucrose
- Pregnant or breast feeding. Refer to section 4.4 for further detail.
- Anemia from another established etiology (i.e MDS, Myeloma)
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.