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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia (Hb<9)
- ClinicalTrials.gov ID
- NCT06061393
- Acronym / sponsor ID
- 0120-23-NHR
- Conditions
- Anemia, Iron Deficiency, Pregnancy Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| venofer | Active comparator | Drug: Venofer 200 MG Per 10 ML InjectionWomen with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with venofer |
| Ferinject | Active comparator | Drug: FerinjectWomen with iron def. anemia aith hemoglobin level <9 gr/dl who will be traeted with ferinject |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnancy>24 weeks of gestation anemia with Hb<9 anemia with Hb<9.5 if symptomatic anemia or previous postpartum hemorrhage
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venofer 200 MG Per 10 ML Injectiontreat anemia with venofer up to 5 doses | Drug | venofer |
| Ferinjectferinject 500 mg, once a week for 2 weeks | Drug | Ferinject |
Primary outcome
ratio of women with Hb level >11 at delivery
Time frame: at delivery
Hb level
postpartum Hb level
Time frame: during 48 hours after delivery
gr/dl
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
Related trials for Anemia, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact maya Wolf, MD (972507887800, mayaw@gmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ratio of women with Hb level >11 at delivery (time frame: at delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.