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

Primary Purpose

Restless Legs Syndrome, Iron Deficiency Anemia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ferumoxytol intravenous

Ferrous sulfate

About this trial

This is an interventional treatment trial for Restless Legs Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Auerbach Hematology Oncology Assoc

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Oral Iron

IV Iron

Arm Description

Ferrous Sulfate 325mg (oral) tabs morning and evening

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

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

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

Patient reported gastrointestinal or constitutional adverse events

Full Information

NCT ID

NCT02499354

First Posted

July 13, 2015

Last Updated

July 24, 2023

Sponsor

Auerbach Hematology Oncology Associates P C

Collaborators

AMAG Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02499354

Brief Title

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

Official Title

Double-blind Comparator of Efficacy of Oral (Ferrous Sulfate) vs. Intravenous Iron (Ferumoxytol) for Treatment of the Restless Legs Syndrome (RLS) Occurring With Iron Deficient Anemia (IDA)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

August 2014 (Actual)

Primary Completion Date

September 28, 2021 (Actual)

Study Completion Date

May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Auerbach Hematology Oncology Associates P C

Collaborators

AMAG Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The restless legs syndrome (RLS) (also known as Willis Ekbom Disease) occurs in about 1/3rd of patients with iron deficiency anemia (IDA). Treatment correcting the IDA is expected to also be effective for reducing or eliminating the RLS with IDA. Two accepted treatments for IDA (oral ferrous sulfate, intravenous ferumoxytol) will be compared for efficacy and speed to response for treatment of RLS occurring with IDA (RLS-IDA). In this study 70 RLS-IDA patients will be randomly assigned 35 each to oral or IV iron treatment using double-blind procedures. Primary outcome with be determined at 6 weeks of treatment with a follow-up at 12 months after treatment. Non-responders at 6 weeks after treatment may, if they qualify, have an open-label IV iron treatment and they will be followed with the same evaluations used after the first set of IV iron treatments. Both oral and IV iron are considered standard treatments for IDA. These same treatments also reduce RLS symptoms. The treatment doses are those accepted for treatment of RLS and also appropriate for treatment for RLS-IDA. Choosing doses equivalent to those for the treatment of RLS without IDA will allow a comparison with that literature. The investigators will therefore use for oral iron ferrous sulfate 325mg taken twice a day matching the dose used in the study of oral iron treatment for RLS without anemia. For IV iron investigators will use ferumoxytol, provided by the sponsor, two doses of 510 mg spaced 2 to 7 days apart. This is the FDA approved dose for treatment of IDA with end stage renal disease. The study is a randomized, comparative open label study to evaluate effect size and time course of treatment response for RLS-IDA over 6 weeks with a 46-week follow-up extension. Two medications and placebos will be used, as described above, with equal random assignment to both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Restless Legs Syndrome, Iron Deficiency Anemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Iron

Arm Type

Active Comparator

Arm Description

Ferrous Sulfate 325mg (oral) tabs morning and evening

Arm Title

IV Iron

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ferumoxytol intravenous

Other Intervention Name(s)

IV iron

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ferrous sulfate

Other Intervention Name(s)

Oral iron

Intervention Description

Oral iron, 325 mg tabs taken morning and evening

Primary Outcome Measure Information:

Title

Change From Baseline in the Restless Legs Syndrome Rating Scale

Description

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

Time Frame

Baseline and at 6 weeks after treatment

Title

Percentage of Participants With Improvement on Clinical Global Impression Scale

Description

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.

Time Frame

Six weeks

Secondary Outcome Measure Information:

Title

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

Description

Patient reported gastrointestinal or constitutional adverse events

Time Frame

Up to six weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Auerbach, MD

Organizational Affiliation

Auerbach Hematology and Oncology Associates, PC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Auerbach Hematology Oncology Assoc

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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