Trial Outcomes & Findings for Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia (NCT NCT00396292)

NCT ID: NCT00396292

Last Updated: 2018-02-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 361 participants
• Primary outcome timeframe: anytime between baseline and the end of study or time to intervention
• Results posted on: 2018-02-05

Participant Flow

Hospitals and medical clinics

8 subjects randomized to VIT-45 were discontinued prior to dosing due to subject request (3 subjects), lost to follow-up (2 subjects), 'other reasons' (2 subjects), and physician decision (1 subject). The 1 subject that was randomized to oral iron was lost to follow-up.

Participant milestones

Measure	VIT-45 A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered	Oral Iron Tablets 325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
Overall Study STARTED	174	178
Overall Study COMPLETED	165	162
Overall Study NOT COMPLETED	9	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia

Baseline characteristics by cohort

Measure	VIT-45 n=174 Participants A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered	Oral Iron Tablets n=178 Participants 325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42	Total n=352 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	159 Participants n=5 Participants	162 Participants n=7 Participants	321 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26.93 years STANDARD_DEVIATION 6.36 • n=5 Participants	26.03 years STANDARD_DEVIATION 5.95 • n=7 Participants	26.41 years STANDARD_DEVIATION 6.17 • n=5 Participants
Sex: Female, Male Female	174 Participants n=5 Participants	178 Participants n=7 Participants	352 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	174 participants n=5 Participants	178 participants n=7 Participants	352 participants n=5 Participants

PRIMARY outcome

Timeframe: anytime between baseline and the end of study or time to intervention

Population: Modified Intent to Treat Population defined as subjects who received at least 1 dose of randomized study medication, had at least 1 post-baseline hemoglobin assessment, and had postpartum anemia characterized by an average of the 2 baseline central laboratory hemoglobin being \<11.0 g/dL

Outcome measures

Measure	VIT-45 n=168 Participants A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered	Oral Iron Tablets n=169 Participants 325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin	162 participants	159 participants

Adverse Events

VIT-45

Serious events: 4 serious events

Other events: 40 other events

Deaths: 0 deaths

Oral Iron Tablets

Serious events: 4 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Measure	VIT-45 n=174 participants at risk A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered	Oral Iron Tablets n=178 participants at risk 325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
Pregnancy, puerperium and perinatal conditions Peripartum cardiomyopathy	0.57% 1/174 • 9 months	0.00% 0/178 • 9 months
Cardiac disorders Cardiac failure	0.57% 1/174 • 9 months	0.00% 0/178 • 9 months
Infections and infestations Postoperative infection	0.57% 1/174 • 9 months	0.00% 0/178 • 9 months
Infections and infestations Appendicitis	0.57% 1/174 • 9 months	0.00% 0/178 • 9 months
Hepatobiliary disorders Cholecystitis	0.57% 1/174 • 9 months	0.00% 0/178 • 9 months
Cardiac disorders Cardiac failure congestive	0.00% 0/174 • 9 months	0.56% 1/178 • 9 months
Vascular disorders Thrombophlebitis	0.00% 0/174 • 9 months	0.56% 1/178 • 9 months
Psychiatric disorders Major depression	0.00% 0/174 • 9 months	0.56% 1/178 • 9 months
Hepatobiliary disorders Cholelithiasis	0.00% 0/174 • 9 months	0.56% 1/178 • 9 months

Other adverse events

Measure	VIT-45 n=174 participants at risk A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered	Oral Iron Tablets n=178 participants at risk 325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
Gastrointestinal disorders Constipation	4.0% 7/174 • 9 months	14.0% 25/178 • 9 months
Gastrointestinal disorders Nausea	1.7% 3/174 • 9 months	8.4% 15/178 • 9 months
Nervous system disorders Headache	17.2% 30/174 • 9 months	11.8% 21/178 • 9 months

Additional Information

Marc Tokars

Luitpold Pharmaceuticals, Inc.

Phone: 610-650-4200

Email: mtokars@lpicrd.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60