Trial Outcomes & Findings for Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia (NCT NCT00740246)

Last Updated: 2025-04-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

594 participants

Primary outcome timeframe

Day 0 to 7

Results posted on

2025-04-18

Participant Flow

Hospitals and medical clinics

Participant milestones

Participant milestones
Measure	VIT-45/Placebo VIT-45 (15 mg/kg up to a maximum of 1000 mg) given on Day 0. After a washout period of 1 week, they then received Placebo on Day 7	Placebo/VIT-045 Placebo given on Day 0. After a washout period of 1 week, they then received VIT-45 (15 mg/kg up to a maximum of 1000 mg) given on Day 0.
Overall Study STARTED	305	289
Overall Study COMPLETED	291	277
Overall Study NOT COMPLETED	14	12

Reasons for withdrawal

Reasons for withdrawal
Measure	VIT-45/Placebo VIT-45 (15 mg/kg up to a maximum of 1000 mg) given on Day 0. After a washout period of 1 week, they then received Placebo on Day 7	Placebo/VIT-045 Placebo given on Day 0. After a washout period of 1 week, they then received VIT-45 (15 mg/kg up to a maximum of 1000 mg) given on Day 0.
Overall Study Received Blood Transfusion	0	1
Overall Study Adverse Event	1	2
Overall Study Selection Criteria/Study Compliance	2	0
Overall Study Lost to Follow-up	2	2
Overall Study Withdrawal by Subject	4	3
Overall Study Withdrawn By Site Due To non-compliance	1	0
Overall Study Discontinued Due To Hurricane Related Issue	1	1
Overall Study Unable To Perform Venipuncture For Day 7, Day 14 Labs, and Day 7 Infusion	1	0
Overall Study Unable To Comply With Study Visits	2	0
Overall Study Unable to Access Vein	0	2
Overall Study Early Term - Patient could not return for second infusion due to Thanksgiving Holiday	0	1

Baseline Characteristics

Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VIT-45 n=305 Participants 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.	Placebo n=289 Participants 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.	Total n=594 Participants Total of all reporting groups
Sex: Female, Male Male	269 Participants n=99 Participants	255 Participants n=107 Participants	524 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	41.2 years STANDARD_DEVIATION 16.4325 • n=99 Participants	42.6 years STANDARD_DEVIATION 16.9296 • n=107 Participants	41.9 years STANDARD_DEVIATION 16.6767 • n=206 Participants
Sex: Female, Male Female	36 Participants n=99 Participants	34 Participants n=107 Participants	70 Participants n=206 Participants
Race (NIH/OMB) Asian	49 Participants n=99 Participants	52 Participants n=107 Participants	101 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	190 Participants n=99 Participants	178 Participants n=107 Participants	368 Participants n=206 Participants
Race (NIH/OMB) White	62 Participants n=99 Participants	48 Participants n=107 Participants	110 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=99 Participants	11 Participants n=107 Participants	15 Participants n=206 Participants
Region of Enrollment United States	305 participants n=99 Participants	289 participants n=107 Participants	594 participants n=206 Participants
Weight	80.6 kilograms STANDARD_DEVIATION 80.6 • n=99 Participants	80.6 kilograms STANDARD_DEVIATION 80.6 • n=107 Participants	80.6 kilograms STANDARD_DEVIATION 8.6 • n=206 Participants

PRIMARY outcome

Timeframe: Day 0 to 7

Population: At Least 1 Treatment-Emergent Adverse Event

Outcome measures

Outcome measures
Measure	ViT-45 n=584 Participants VIT-45 given on Day 0 or Day 7	Placebo n=569 Participants Placebo given on Day 0 or Day 7.
Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period	174 participants	114 participants

Adverse Events

VIT-45 on Day 0 or Day 7

Serious events: 2 serious events

Other events: 31 other events

Deaths: 1 deaths

Placebo on Day 0 or Day 7

Serious events: 4 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	VIT-45 on Day 0 or Day 7 n=584 participants at risk Participants received VIT-45 on either Day 0 or Day 7 (a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously)	Placebo on Day 0 or Day 7 n=569 participants at risk Participants received Placebo on Day 0 or 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)
Infections and infestations Pneumonia	0.17% 1/584 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).	0.00% 0/569 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).
Gastrointestinal disorders Intestinal obstruction	0.17% 1/584 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).	0.00% 0/569 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).
Metabolism and nutrition disorders Diabetes mellitus non-insulin dependent	0.00% 0/584 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).	0.18% 1/569 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).
Vascular disorders Hypertension	0.00% 0/584 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).	0.18% 1/569 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/584 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).	0.18% 1/569 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/584 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).	0.18% 1/569 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).
Infections and infestations Endometritis	0.00% 0/584 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).	0.18% 1/569 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).
Injury, poisoning and procedural complications Fall	0.00% 0/584 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).	0.18% 1/569 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).

Other adverse events

Other adverse events
Measure	VIT-45 on Day 0 or Day 7 n=584 participants at risk Participants received VIT-45 on either Day 0 or Day 7 (a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously)	Placebo on Day 0 or Day 7 n=569 participants at risk Participants received Placebo on Day 0 or 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)
Nervous system disorders Headache	5.3% 31/584 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).	3.3% 19/569 • 7 days 594 who received at least 1 dose of study medication were included in the Safety Population (SP). For VIT-45 exposure, 10 subjects that were scheduled to receive VIT-45 as a 2nd dose did not (582-10 = 572 safety exposures from crossover portion). After including the 12 PK subjects, a total of 584 subjects were included in the SP. For the placebo exposure, 13 subjects that were scheduled to receive placebo as a 2nd dose did not did not (582-13 = 569 safety exposures from crossover portion).

Additional Information

Mark A Falone

Luitpold Pharmaceuticals, Inc.

Phone: 610-650-4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60