AnemiaPhase 3NCT00740246
Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia
A Phase 3 study testing VIT-45 in people with Anemia, run by American Regent, Inc. at 1 site in United States.
Trial summary
The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- VIT-45
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 594 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to May 2006
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects > or = 18 years of age and able to give informed consent
- Historical laboratory Hgb indicative of anemia within 3 months prior to screening visit
- Screening Visit laboratory Hgb indicative of anemia
- Screening Visit ferritin indicative of iron deficiency anemia
Who cannot join
- Known hypersensitivity to VIT-45
- Previously received VIT-45
- Parenteral iron in the 4 weeks prior to screening
- Chronic or serious active infection
- Malignancy history
- Aspartate aminotransferase (AST) or Alanine transaminase( ALT) greater than the upper limit of normal
- Anticipated need for surgery or initiation of dialysis during the study
- Pregnant or sexually active females who are not willing to use an effective form of birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
Luitpold Pharmaceuticals
Norristown, Pennsylvania, 19403
About this study
Official title: A Multi-Center, Randomized, Blinded, Placebo Controlled, Cross-Over Study to Investigate the Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia
The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
Read the detailed description
Evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
- Conditions
- Anemia
- Being tested
- VIT-45, Placebo
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIT-45Drug
Also called ferric carboxymaltose
15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously
PlaceboDrug
for weight >33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously
| Study group | Role | What they receive |
|---|---|---|
| VIT-45 on Day 0, then Placebo on Day 7 | Experimental | Day 0: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously.
Day 7: for weight >33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously. Receives: Drug: VIT-45; Drug: Placebo |
| Placebo on Day 0, then VIT-45 on Day 7 | Experimental | Day 0: for weight >33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously.
Day 7: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously. Receives: Drug: VIT-45; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period
Number of participants with any treatment-emergent adverse events experienced by participants. The 7-day study period for Study Period 1 ended with the initiation of dosing for Study Period 2. The 7-day study period fo Study Period 2 ended with the completion of Day 14 procedures.
Measured: Day 0 to 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startJul 2005
- Primary completionFeb 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 594 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Bregman, MD, Study director, American Regent, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740246
- Sponsor's protocol ID
- 1VIT05006
- Status last verified
- Apr 2025
- First submitted
- 21 Aug 2008
- Last updated
- 18 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Seid MH, Valaoras TG, Barish CF, Dinh Q. Safety Profile of Ferric Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia. Society for the Advancement of Blood Management 2007.
Seid MH, Mangione A, Valaoras TG, Anthony LB, Barish CF. Safety Profile of Ferric Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia. Society for the Advancement of Blood Management 2007.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Blinded, Placebo Controlled, Cross-Over Study to Investigate the Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT00740246
- Acronym / sponsor ID
- 1VIT05006
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 594 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2005 (actual)
- Primary completion
- Feb 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 22 Aug 2008 (estimated)
- Results
- Posted 18 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
Detailed description
Evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIT-45 on Day 0, then Placebo on Day 7 | Experimental | Drug: VIT-45, Drug: PlaceboDay 0: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously. Day 7: for weight >33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously. |
| Placebo on Day 0, then VIT-45 on Day 7 | Experimental | Drug: VIT-45, Drug: PlaceboDay 0: for weight >33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously. Day 7: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects > or = 18 years of age and able to give informed consent
- Historical laboratory Hgb indicative of anemia within 3 months prior to screening visit
- Screening Visit laboratory Hgb indicative of anemia
- Screening Visit ferritin indicative of iron deficiency anemia
Key exclusion criteria (8 listed)
- Known hypersensitivity to VIT-45
- Previously received VIT-45
- Parenteral iron in the 4 weeks prior to screening
- Chronic or serious active infection
- Malignancy history
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 |
|---|---|---|
| VIT-45Also: ferric carboxymaltose15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously | Drug | Placebo on Day 0, then VIT-45 on Day 7, VIT-45 on Day 0, then Placebo on Day 7 |
| Placebofor weight >33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously | Drug | Placebo on Day 0, then VIT-45 on Day 7, VIT-45 on Day 0, then Placebo on Day 7 |
Primary outcome
Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period
Time frame: Day 0 to 7
Number of participants with any treatment-emergent adverse events experienced by participants. The 7-day study period for Study Period 1 ended with the initiation of dosing for Study Period 2. The 7-day study period fo Study Period 2 ended with the completion of Day 14 procedures.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationSeid MH, Valaoras TG, Barish CF, Dinh Q. Safety Profile of Ferric Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia. Society for the Advancement of Blood Management 2007.
- Results publicationSeid MH, Mangione A, Valaoras TG, Anthony LB, Barish CF. Safety Profile of Ferric Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia. Society for the Advancement of Blood Management 2007.
- Individual participant dataSharing planned: No
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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. This study is not recruiting at the moment.
David Bregman, MD study director
American Regent, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VIT-45 in people with Anemia, run by American Regent, Inc. at 1 site in United States.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 18 Apr 2025. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period (time frame: Day 0 to 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00740246, which also lists 2 linked publications.
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 18 Apr 2025.