Trial Outcomes & Findings for Pilot Study: Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of RLS With IDA. (IVOR-IDA) (NCT NCT02499354)

NCT ID: NCT02499354

Last Updated: 2024-01-30

Results Overview

Change in International Restless Legs Severity Scale (IRLS) score reflecting RLS severity on the scale of 0-40. The higher the negative score the better the outcome

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 100 participants
• Primary outcome timeframe: Baseline and at 6 weeks after treatment
• Results posted on: 2024-01-30

Participant Flow

Participant milestones

Measure	Oral Iron Ferrous Sulfate 325mg (oral) tabs morning and evening Ferrous sulfate: Oral iron, 325 mg tabs taken morning and evening In this arm participants also received intravenous normal saline as part of a double blind, double dummy design	IV Iron Ferumoxytol intravenous (IV) 1020 mg - 2 vials of 510 mg (IV push, 2-3 mins) each given 2-7 days apart Ferumoxytol intravenous: IV iron, 2 vials of 510 mg given 2-7 days apart In this arm participants received oral vitamin C as part of a double blind, double dummy design
Overall Study STARTED	46	47
Overall Study COMPLETED	45	47
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Oral Iron Ferrous Sulfate 325mg (oral) tabs morning and evening Ferrous sulfate: Oral iron, 325 mg tabs taken morning and evening In this arm participants also received intravenous normal saline as part of a double blind, double dummy design	IV Iron Ferumoxytol intravenous (IV) 1020 mg - 2 vials of 510 mg (IV push, 2-3 mins) each given 2-7 days apart Ferumoxytol intravenous: IV iron, 2 vials of 510 mg given 2-7 days apart In this arm participants received oral vitamin C as part of a double blind, double dummy design
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Pilot Study: Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of RLS With IDA. (IVOR-IDA)

Baseline characteristics by cohort

Measure	Oral Iron n=46 Participants Ferrous Sulfate 325mg (oral) tabs morning and evening Ferrous sulfate: Oral iron, 325 mg tabs taken morning and evening In this arm participants also received intravenous normal saline as part of a double blind, double dummy design	IV Iron n=47 Participants Ferumoxytol intravenous (IV) 1020 mg - 2 vials of 510 mg (IV push, 2-3 mins) each given 2-7 days apart Ferumoxytol intravenous: IV iron, 2 vials of 510 mg given 2-7 days apart In this arm participants received oral vitamin C as part of a double blind, double dummy design	Total n=93 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	44 Participants n=5 Participants	45 Participants n=7 Participants	89 Participants n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	40 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	42 Participants n=7 Participants	81 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	47 participants n=7 Participants	93 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and at 6 weeks after treatment

Population: Those participants with baseline data and at 6 weeks

Change in International Restless Legs Severity Scale (IRLS) score reflecting RLS severity on the scale of 0-40. The higher the negative score the better the outcome

Outcome measures

Measure	Oral Iron n=45 Participants Ferrous Sulfate 325mg (oral) tabs morning and evening Ferrous sulfate: Oral iron, 325 mg tabs taken morning and evening In this arm participants also received intravenous normal saline as part of a double blind, double dummy design	IV Iron n=47 Participants Ferumoxytol intravenous (IV) 1020 mg - 2 vials of 510 mg (IV push, 2-3 mins) each given 2-7 days apart Ferumoxytol intravenous: IV iron, 2 vials of 510 mg given 2-7 days apart In this arm participants received oral vitamin C as part of a double blind, double dummy design
Change From Baseline in the Restless Legs Syndrome Rating Scale	-14.0000 units on a scale Standard Deviation 9.75	-9.7353 units on a scale Standard Deviation 8.33

PRIMARY outcome

Timeframe: Six weeks

Population: Those participants with data at six weeks

Seven questions ranging from Very Much Improved to Very Much Worse: Participant had to be at least Very Much Improved to be considered as having improved. The CGI scale consisted of one question.

Outcome measures

Measure	Oral Iron n=45 Participants Ferrous Sulfate 325mg (oral) tabs morning and evening Ferrous sulfate: Oral iron, 325 mg tabs taken morning and evening In this arm participants also received intravenous normal saline as part of a double blind, double dummy design	IV Iron n=47 Participants Ferumoxytol intravenous (IV) 1020 mg - 2 vials of 510 mg (IV push, 2-3 mins) each given 2-7 days apart Ferumoxytol intravenous: IV iron, 2 vials of 510 mg given 2-7 days apart In this arm participants received oral vitamin C as part of a double blind, double dummy design
Percentage of Participants With Improvement on Clinical Global Impression Scale	75 percentage of participants	68 percentage of participants

SECONDARY outcome

Timeframe: Up to six weeks

Patient reported gastrointestinal or constitutional adverse events

Outcome measures

Measure	Oral Iron n=46 Participants Ferrous Sulfate 325mg (oral) tabs morning and evening Ferrous sulfate: Oral iron, 325 mg tabs taken morning and evening In this arm participants also received intravenous normal saline as part of a double blind, double dummy design	IV Iron n=47 Participants Ferumoxytol intravenous (IV) 1020 mg - 2 vials of 510 mg (IV push, 2-3 mins) each given 2-7 days apart Ferumoxytol intravenous: IV iron, 2 vials of 510 mg given 2-7 days apart In this arm participants received oral vitamin C as part of a double blind, double dummy design
Number of Participants With Adverse Events Judged Related or Possibly Related to Treatment.	22 Participants	11 Participants

Adverse Events

Oral Iron

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

IV Iron

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Oral Iron n=46 participants at risk Ferrous Sulfate 325mg (oral) tabs morning and evening Ferrous sulfate: Oral iron, 325 mg tabs taken morning and evening In this arm participants also received intravenous normal saline as part of a double blind, double dummy design	IV Iron n=47 participants at risk Ferumoxytol intravenous (IV) 1020 mg - 2 vials of 510 mg (IV push, 2-3 mins) each given 2-7 days apart Ferumoxytol intravenous: IV iron, 2 vials of 510 mg given 2-7 days apart In this arm participants received oral vitamin C as part of a double blind, double dummy design
Gastrointestinal disorders Constipation	17.4% 8/46 • Up to six weeks	2.1% 1/47 • Up to six weeks
Gastrointestinal disorders Diarrhea	8.7% 4/46 • Up to six weeks	4.3% 2/47 • Up to six weeks
Gastrointestinal disorders Mouth Burn	0.00% 0/46 • Up to six weeks	2.1% 1/47 • Up to six weeks
Gastrointestinal disorders Gastric Irritation	15.2% 7/46 • Up to six weeks	10.6% 5/47 • Up to six weeks
Musculoskeletal and connective tissue disorders Arthralgia/myalgia	6.5% 3/46 • Up to six weeks	8.5% 4/47 • Up to six weeks
General disorders Edema	2.2% 1/46 • Up to six weeks	2.1% 1/47 • Up to six weeks
Gastrointestinal disorders Oral iron intolerance	2.2% 1/46 • Up to six weeks	0.00% 0/47 • Up to six weeks

Additional Information

Dr. Michael Auerbach

Auerbach Hematology Oncology Assoc

Phone: 410-780-4050

Email: mauerbachmd@abhemonc.com

Results disclosure agreements

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