Anemia, Iron DeficiencyPhase 4NCT06061393
Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia
A Phase 4 study testing Venofer 200 MG Per 10 ML Injection and Ferinject in people with Anemia, Iron Deficiency and Pregnancy Anemia, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
The purpose of this study is to compare maternal outcomes such as increased hemoglobin need for blood transfusion and hemoglobin level before and post partum in women with hemoglobin <9 gr/dl , treated with venofer and women treated with ferinject. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Anemia, Iron Deficiency, Pregnancy Anemia
- What is being tested?
- Venofer 200 MG Per 10 ML Injection and Ferinject
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Nov 2023to Dec 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnancy>24 weeks of gestation anemia with Hb<9 anemia with Hb<9.5 if symptomatic anemia or previous postpartum hemorrhage
Who cannot join
- Allergy to one of the study's drugs
- IV iron treatment in the last month
- Underlying medical conditions associated with anemia, such as thalassemia Major, renal insufficiency, or spherocytosis
- Twin pregnancy
- non iron deficiency anemia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Galilee Medical Center
Nahariya
Maya Wolf, MD, 972-507887800
About this study
Official title: Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia (Hb<9)
The purpose of this study is to compare maternal outcomes such as increased hemoglobin need for blood transfusion and hemoglobin level before and post partum in women with hemoglobin <9 gr/dl , treated with venofer and women treated with ferinject.
- Conditions
- Anemia, Iron Deficiency, Pregnancy Anemia
- Being tested
- Venofer 200 MG Per 10 ML Injection, Ferinject
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venofer 200 MG Per 10 ML InjectionDrug
treat anemia with venofer up to 5 doses
FerinjectDrug
ferinject 500 mg, once a week for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| venofer | Active comparator | Women with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with venofer Receives: Drug: Venofer 200 MG Per 10 ML Injection |
| Ferinject | Active comparator | Women with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with ferinject Receives: Drug: Ferinject |
What is being measured
The primary outcome is the main question the study is designed to answer.
ratio of women with Hb level >11 at delivery
Hb level
Measured: at delivery
postpartum Hb level
gr/dl
Measured: during 48 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start2 Nov 2023
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Maya Wolf, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061393
- Sponsor's protocol ID
- 0120-23-NHR
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No