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

NCT02499354 | Completed Phase 2 Results

• 1 other identifier: IVOR-IDA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the relative effect size of standard IV and oral iron treatment of RLS with Iron deficiency anemia (IDA) and to determine the time course of treatment response.

Conditions

Restless Legs Syndrome; Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Restless Legs Syndrome Rating Scale

  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

  Baseline and at 6 weeks after treatment

• Percentage of Participants With Improvement on Clinical Global Impression Scale

  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.

  Six weeks

Secondary Outcomes (1)

• Number of Participants With Adverse Events Judged Related or Possibly Related to Treatment.

  Up to six weeks

Study Arms (2)

Oral Iron

ACTIVE COMPARATOR

Ferrous Sulfate 325mg (oral) tabs morning and evening

Drug: Ferrous sulfate

IV Iron

ACTIVE COMPARATOR

Ferumoxytol intravenous (IV) 1020 mg - 2 vials of 510 mg (IV push, 2-3 mins) each given 2-7 days apart

Drug: Ferumoxytol intravenous

Interventions

Ferumoxytol intravenous DRUG

IV iron, 2 vials of 510 mg given 2-7 days apart

Also known as: IV iron

IV Iron

Ferrous sulfate DRUG

Oral iron, 325 mg tabs taken morning and evening

Also known as: Oral iron

Oral Iron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of RLS based on questionnaire and confirmed by Hopkins telephone Diagnostic Interview conducted by investigators or clinicians part of the study.
• Iron deficiency anemia defined as ID either ferritin \<20 mcg/l, Tsat \<19%, anemia Hgb \<13 for both males and females.
• Willingness to use contraceptive to avoid pregnancy: Women have to be surgically sterile, post-menopausal, or use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, or injections with prolonged release).
• Willingness to participate and signing the informed consent form.

You may not qualify if:

• Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis)
• Decompensated liver cirrhosis or active hepatitis (ALAT \> 3 times upper limit of normal)
• Serum ferritin \> 500 ng/mL or transferrin saturation \>40%
• Active acute or chronic infections (assessed by clinical judgement that may be indicated by White Blood Cells (WBC) and C-Reactive Protein (CRP) when these are available)
• Rheumatoid arthritis with symptoms or signs of active inflammation
• Pregnant and nursing women
• History of multiple allergies
• Known hypersensitivity to parenteral or oral iron or any excipients in the drug products
• Previous IV iron treatment for RLS
• Other iron treatment or blood transfusion within 4 weeks prior to the screening or treatment visit
• Planned elective surgery during the study
• Current (past 4 weeks) use of drugs that treat RLS, e.g. opioids, alpha-2-delta anti-depressants, dopaminergics (dopamine promoters, dopamine antagonists/blockers)
• Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion og the study or place the subject at potential risk from being in the study, e.g. a malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus.

Sponsors & Collaborators

• Auerbach Hematology Oncology Associates P C: lead
• AMAG Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Auerbach Hematology Oncology Assoc

Baltimore, Maryland, 21237, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome; Anemia, Iron-Deficiency

Interventions

ferryl iron; ferrous sulfate; Iron

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Results Point of Contact

• Title: Dr. Michael Auerbach
• Organization: Auerbach Hematology Oncology Assoc

mauerbachmd@abhemonc.com

410-780-4050

Study Officials

• Michael Auerbach, MD

  Auerbach Hematology and Oncology Associates, PC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Michael Auerbach

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 16, 2015
• Study Start: August 1, 2014
• Primary Completion: September 28, 2021
• Study Completion: May 31, 2022
• Last Updated: January 30, 2024
• Results First Posted: August 15, 2023

Record last verified: 2024-01

Locations

US (1)