Anemia
Conditions
Brief summary
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
Interventions
DRUGVIT-45
15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously
DRUGPlacebo
for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously
Sponsors
American Regent, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period | 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. |
Countries
United States
Participant flow
Recruitment details
Hospitals and medical clinics
Participants by arm
| Arm | Count |
|---|---|
| VIT-45 VIT-45 given on Day 0 and Placebo on Day 7. For assessment purposes, this arm included all subjects who received VIT-45 at Day 0 and Day 7. Also included in this assessment was 12 pharmacokinetic (PK) patients. The PK portion of the study was open-label, not part of the cross-over design, where subjects received 1 unblinded dose of VIT-45 at Day 0. Select sites participated and subjects were enrolled if they agreed to the extra blood draws. | 305 |
| Placebo Placebo given on Day 0 and VIT-45 on Day 7. For assessment purposes, this arm included all subjects who received Placebo at Day 0 and Day 7. | 289 |
| Total | 594 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Discontinued Due To Hurricane Related Issue | 1 | 1 |
| Overall Study | Early Term - Patient could not return for second infusion due to Thanksgiving Holiday | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Received Blood Transfusion | 0 | 1 |
| Overall Study | Selection Criteria/Study Compliance | 2 | 0 |
| Overall Study | Unable to Access Vein | 0 | 2 |
| Overall Study | Unable To Comply With Study Visits | 2 | 0 |
| Overall Study | Unable To Perform Venipuncture For Day 7, Day 14 Labs, and Day 7 Infusion | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
| Overall Study | Withdrawn By Site Due To non-compliance | 1 | 0 |
Baseline characteristics
| Characteristic | VIT-45 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 41.2 years STANDARD_DEVIATION 16.4325 | 42.6 years STANDARD_DEVIATION 16.9296 | 41.9 years STANDARD_DEVIATION 16.6767 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 49 Participants | 52 Participants | 101 Participants |
| Race (NIH/OMB) Black or African American | 190 Participants | 178 Participants | 368 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 11 Participants | 15 Participants |
| Race (NIH/OMB) White | 62 Participants | 48 Participants | 110 Participants |
| Region of Enrollment United States | 305 participants | 289 participants | 594 participants |
| Sex: Female, Male Female | 36 Participants | 34 Participants | 70 Participants |
| Sex: Female, Male Male | 269 Participants | 255 Participants | 524 Participants |
| Weight | 80.6 kilograms STANDARD_DEVIATION 80.6 | 80.6 kilograms STANDARD_DEVIATION 80.6 | 80.6 kilograms STANDARD_DEVIATION 8.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 584 | 0 / 569 |
| other Total, other adverse events | 31 / 584 | 19 / 569 |
| serious Total, serious adverse events | 2 / 584 | 4 / 569 |
Outcome results
Primary
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.
Time frame: Day 0 to 7
Population: At Least 1 Treatment-Emergent Adverse Event
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ViT-45 | Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period | 174 participants |
| Placebo | Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period | 114 participants |