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Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)

Primary Purpose

Iron Deficiency Anaemia, Iron Deficiency Anemia

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Iron isomaltoside/ferric derisomaltose

Iron sucrose

About this trial

This is an interventional treatment trial for Iron Deficiency Anaemia focused on measuring Iron Deficiency Anaemia, Iron Deficiency Anemia, IDA, Intravenous iron replacement therapy, Iron isomaltoside, Ferric derisomaltose, Monofer, Monoferric, Monover, Monofar, Monoferro

Eligibility Criteria

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

Inclusion criteria includes:

Men or women ≥ 18 years
Subjects having IDA caused by different etiologies
Subjects with intolerance to oral iron therapy or a need for rapid repletion of iron stores:
Haemoglobin (Hb) ≤ 11 g/dL
Transferrin Saturation (TSAT) < 20 %
S-ferritin < 100 ng/mL
Willingness to participate and signing the informed consent form

Exclusion Criteria includes :

Anemia predominantly caused by factors other than IDA
Hemochromatosis or other iron storage disorders
Previous serious hypersensitivity reactions to any IV iron compound
Erythropoiesis stimulating agent (ESA) treatment
Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
Will require a surgical procedure that necessitated general anesthesia prior to screening or during the trial period
Alanine aminotransferase and/or aspartate aminotransferase > 3 times upper limit of normal
Required dialysis for treatment of chronic kidney disease (CKD)
Alcohol or drug abuse within the past 6 months
Pregnant or nursing women

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iron isomaltoside/ferric derisomaltose

Iron sucrose

Arm Description

Administered IV

Outcomes

Primary Outcome Measures

Change in Hemoglobin (Hb) From Baseline to Week 8

Efficacy Evaluate the effect on the hemoglobin (Hb) level following treatment with iron isomaltoside/ferric derisomaltose vs iron sucrose in subjects with iron deficiency anaemia (IDA) . Response was defined as change from baseline in hemoglobin (Hb) to week 8, i.e. ability to increase Hb in subjects with IDA, when oral iron preparations were ineffective or could not be used or in whom the screening Hb measurement in Investigators' opinion were sufficiently low to require rapid repletion of iron stores.

Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions

Safety For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity reactions that were included in the analysis were those that started on or after the first dose of randomised treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: loss of consciousness, seizure, syncope, unresponsiveness. The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC). Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions.

Secondary Outcome Measures

Composite Cardiovascular Adverse Events (AEs)

Safety Results show the composite cardiovascular adverse events (AEs), that started on or after the first dose of randomised treatment (i.e. treatment emergent) up to week 8. The reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC). The potential cardiovascular AEs included the following: Death due to any cause Non-fatal myocardial infarction Non-fatal stroke Unstable angina requiring hospitalisation Congestive heart failure requiring hospitalisation or medical intervention Arrhythmias Hypertension Hypotension Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs.

Time to First Composite Cardiovascular Safety AE

Safety Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the CEAC, were considered for this endpoint. Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit.

S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8

Safety Results show the number of subjects who had s-phosphate <2 mg/dL at any time from baseline to week 1, 2, 4, or 8.

Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8

Efficacy Results show responders to the treatment. A subject was considered a Hb responder to a certain week if an increase in Hb of at least 2 g/dL from baseline to the week in question was observed (week 1, 2, 4, and 8).

Time to Change in Hb Concentration ≥2 g/dL

Efficacy Time to change in Hb concentration ≥2 g/dL. Subjects who achieved Hb concentration increase of ≥2 g/dL (from baseline to week 1, 2, 4, or 8). For responders, time to Hb response was defined as the scheduled time from baseline until the visit where the first Hb response was measured.

Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8

Efficacy Hb concentration of >12 g/dL at any time from week 1 to week 8. Results show the number of participants who achieved Hb concentration of >12 g/dL at any time from week 1 to week 8.

Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8

Efficacy Results show the number of participants who achieved Hb concentration increase of ≥2 g/dL at any time from week 1 to week 8.

S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8

Efficacy Proportion of subjects reaching the composite endpoint of s-ferritin concentration ≥100 ng/mL and TSAT of 20-50% at any time from week 1 to 8.

Change in Hb Concentration From Baseline to Week 1, 2, and 4

Efficacy Change in Hb concentration from baseline to week 1, 2, and 4.

Change in S-ferritin Concentration From Baseline to Weeks 1, 2, 4, and 8

Efficacy Change in s-ferritin concentration from baseline to weeks 1, 2, 4, and 8.

Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8

Efficacy Changes in transferrin saturation (TSAT) from baseline to week 1, 2, 4, and 8. TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron.

Change in Concentrations of Serum Iron (S-iron) From Baseline to Week 1, 2, 4, and 8

Efficacy Changes in the concentrations of serum iron (s-iron) from baseline to week 1, 2, 4, and 8.

Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8

Efficacy Change in fatigue symptoms from baseline to week 1, 2, and 8 was measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale consisted of 13 items ranging from 0 (not at all) to 4 (very much), except items #7 and #8 which are reversed scored. The total score range is 0-52. A score of less than 30 indicated severe fatigue, and the higher the score, the better outcome/quality of life (QoL). If more than 50% of the items for a subject at a given visit were missing, the total score was not calculated. Total score was calculated as shown below: Total score= Sum of individual scores x 13 / Number of items answered

Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking

Pharmacoeconomics The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group).

Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car

Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit

Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits

Health Care Resource Use Questionnaire

Pharmacoeconomics Resources used by the health care staff (per administration), measured by the health care resource use questionnaire. The questionnaire assessed the time used by the health care staff during administration of the investigational product and the administration time (including the observational time). The health care participants included in the evaluation were: investigator, pharmacist, physician, study coordinator, study nurse. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the treatment groups is different (i.e. up to a factor 5 more frequent in the iron sucrose treatment group).

Full Information

NCT ID

NCT02940886

First Posted

September 27, 2016

Last Updated

September 15, 2020

Sponsor

Pharmacosmos A/S

1. Study Identification

Unique Protocol Identification Number

NCT02940886

Brief Title

Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)

Official Title

A Phase III, Randomised, Open-label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®) and Iron Sucrose in Subjects With Iron Deficiency Anemia (FERWON-IDA)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

November 8, 2016 (Actual)

Primary Completion Date

March 28, 2018 (Actual)

Study Completion Date

March 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pharmacosmos A/S

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Evaluate safety and efficacy of iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®) compared with iron sucrose (Venofer®), in subjects diagnosed with IDA.

Detailed Description

IDA is highly prevalent condition in subjects with cancer and gastrointestinal diseases such as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone bariatric procedure or surgery. IDA can have a substantial medical and quality of life (QoL) burden. Treatment of subjects diagnosed with IDA includes controlling the bleeding and replenishing lost iron. This study was designed to evaluate the safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose in subjects diagnosed with IDA. In a subfraction of 35 subjects treated with iron isomaltoside/ferric derisomaltose, ECG and iron will be frequently measured. The study subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or iron sucrose (200 mg IV injections at baseline and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline; a cumulative dose of 1000 mg was recommended). The study subjects were monitored for up to 8 weeks from baseline.

6. Conditions and Keywords

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

Iron Deficiency Anaemia, Iron Deficiency Anemia

Keywords

Iron Deficiency Anaemia, Iron Deficiency Anemia, IDA, Intravenous iron replacement therapy, Iron isomaltoside, Ferric derisomaltose, Monofer, Monoferric, Monover, Monofar, Monoferro

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1512 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Iron isomaltoside/ferric derisomaltose

Arm Type

Experimental

Arm Description

Administered IV

Arm Title

Iron sucrose

Arm Type

Active Comparator

Arm Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Iron isomaltoside/ferric derisomaltose

Other Intervention Name(s)

Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®

Intervention Description

Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial. The dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride (100 mL bags) and administered as a single IV infusion over approximately 20 minutes.

Intervention Type

Drug

Intervention Name(s)

Iron sucrose

Other Intervention Name(s)

Venofer®

Intervention Description

Iron sucrose (Venofer®; 20 mg elemental iron/mL) was the comparator in this trial. Iron sucrose was administered as 200 mg undiluted IV injections over approximately 2-5 minutes and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline. A cumulative dose of 1000 mg was recommended.

Primary Outcome Measure Information:

Title

Change in Hemoglobin (Hb) From Baseline to Week 8

Description

Time Frame

Baseline to week 8

Title

Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions

Description

Time Frame

Baseline to week 8

Secondary Outcome Measure Information:

Title

Composite Cardiovascular Adverse Events (AEs)

Description

Time Frame

Baseline, week 1, 2, and 8

Title

Time to First Composite Cardiovascular Safety AE

Description

Time Frame

Baseline, week 1, 2, 4, and 8

Title

S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8

Description

Safety Results show the number of subjects who had s-phosphate <2 mg/dL at any time from baseline to week 1, 2, 4, or 8.

Time Frame

Baseline, week 1, 2, 4, and 8

Title

Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8

Description

Time Frame

Baseline, week 1, 2, 4, and 8

Title

Time to Change in Hb Concentration ≥2 g/dL

Description

Time Frame

Baseline, week 1, 2, 4, and 8

Title

Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8

Description

Efficacy Hb concentration of >12 g/dL at any time from week 1 to week 8. Results show the number of participants who achieved Hb concentration of >12 g/dL at any time from week 1 to week 8.

Time Frame

Week 1 to week 8

Title

Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8

Description

Efficacy Results show the number of participants who achieved Hb concentration increase of ≥2 g/dL at any time from week 1 to week 8.

Time Frame

Week 1 to week 8

Title

S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8

Description

Efficacy Proportion of subjects reaching the composite endpoint of s-ferritin concentration ≥100 ng/mL and TSAT of 20-50% at any time from week 1 to 8.

Time Frame

Week 1 to week 8

Title

Change in Hb Concentration From Baseline to Week 1, 2, and 4

Description

Efficacy Change in Hb concentration from baseline to week 1, 2, and 4.

Time Frame

Baseline, week 1, 2, and 4

Title

Change in S-ferritin Concentration From Baseline to Weeks 1, 2, 4, and 8

Description

Efficacy Change in s-ferritin concentration from baseline to weeks 1, 2, 4, and 8.

Time Frame

Baseline, week 1, 2, 4, and 8

Title

Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8

Description

Time Frame

Baseline, week 1, 2, 4, and 8

Title

Change in Concentrations of Serum Iron (S-iron) From Baseline to Week 1, 2, 4, and 8

Description

Efficacy Changes in the concentrations of serum iron (s-iron) from baseline to week 1, 2, 4, and 8.

Time Frame

Baseline, week 1, 2, 4, and 8

Title

Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8

Description

Time Frame

Baseline, week 1, 2, and 8

Title

Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking

Description

Time Frame

Baseline

Title

Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car

Description

Time Frame

Baseline

Title

Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit

Description

Time Frame

Baseline

Title

Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits

Description

Time Frame

Baseline

Title

Health Care Resource Use Questionnaire

Description

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria includes: Men or women ≥ 18 years Subjects having IDA caused by different etiologies Subjects with intolerance to oral iron therapy or a need for rapid repletion of iron stores: Haemoglobin (Hb) ≤ 11 g/dL Transferrin Saturation (TSAT) < 20 % S-ferritin < 100 ng/mL Willingness to participate and signing the informed consent form Exclusion Criteria includes : Anemia predominantly caused by factors other than IDA Hemochromatosis or other iron storage disorders Previous serious hypersensitivity reactions to any IV iron compound Erythropoiesis stimulating agent (ESA) treatment Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy Will require a surgical procedure that necessitated general anesthesia prior to screening or during the trial period Alanine aminotransferase and/or aspartate aminotransferase > 3 times upper limit of normal Required dialysis for treatment of chronic kidney disease (CKD) Alcohol or drug abuse within the past 6 months Pregnant or nursing women

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pharmacosmos A/S Clinical and Non-clinical Research

Organizational Affiliation

Pharmacosmos A/S

Official's Role

Study Director

Facility Information:

Facility Name

Pharmacosmos Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36305

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Guntersville

State/Province

Alabama

ZIP/Postal Code

35976

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72204

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Foothill Ranch

State/Province

California

ZIP/Postal Code

92610

Country

United States

Facility Name

Pharmacosmos Investigational Site 1

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Pharmacosmos Investigational Site 2

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

National City

State/Province

California

ZIP/Postal Code

91950

Country

United States

Facility Name

Pharmacosmos Investigational Site 1

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

Facility Name

Pharmacosmos Investigational Site 2

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Quartz Hill

State/Province

California

ZIP/Postal Code

93536

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Rialto

State/Province

California

ZIP/Postal Code

92377

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Riverside

State/Province

California

ZIP/Postal Code

92501

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92117

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

San Marcos

State/Province

California

ZIP/Postal Code

92078

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Whittier

State/Province

California

ZIP/Postal Code

90603

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Plainville

State/Province

Connecticut

ZIP/Postal Code

06062

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33426

Country

United States

Facility Name

Pharmacosmos Investigational Site 1

City

Doral

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Pharmacosmos Investigational Site 2

City

Doral

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Doral

State/Province

Florida

ZIP/Postal Code

33172

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33015

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34741

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Lake City

State/Province

Florida

ZIP/Postal Code

32024

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Lake Worth

State/Province

Florida

ZIP/Postal Code

33461

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Lake Worth

State/Province

Florida

ZIP/Postal Code

33467

Country

United States

Facility Name

Pharmacosmos Investigational Site 1

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Pharmacosmos Investigational Site 2

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33015

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33130

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Pharmacosmos Investigational Site 1

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Pharmacosmos Investigational Site 2

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33147

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33174

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33185

Country

United States

Facility Name

Pharmacosmos Investigational Site 1

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Pharmacosmos Investigational Site 2

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Palmetto Bay

State/Province

Florida

ZIP/Postal Code

33157

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Champaign

State/Province

Illinois

ZIP/Postal Code

61820

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Joliet

State/Province

Illinois

ZIP/Postal Code

60435

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Palos Heights

State/Province

Illinois

ZIP/Postal Code

60463

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Terre Haute

State/Province

Indiana

ZIP/Postal Code

47802

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42303

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Marrero

State/Province

Louisiana

ZIP/Postal Code

70072

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70125

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71103

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21740

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02720

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49525

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Saginaw

State/Province

Michigan

ZIP/Postal Code

48604

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Troy

State/Province

Michigan

ZIP/Postal Code

48085

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Florissant

State/Province

Missouri

ZIP/Postal Code

63031

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89109

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Neptune

State/Province

New Jersey

ZIP/Postal Code

07753

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Plainsboro

State/Province

New Jersey

ZIP/Postal Code

08536

Country

United States

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11235

Country

United States

Facility Name

Pharmacosmos Investigational Site 1

City

East Setauket

State/Province

New York

ZIP/Postal Code

11733

Country

United States

Facility Name

Pharmacosmos Investigational Site 2

City

East Setauket

State/Province

New York

ZIP/Postal Code

11733

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28403

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Beavercreek

State/Province

Ohio

ZIP/Postal Code

45431

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Centerville

State/Province

Ohio

ZIP/Postal Code

45459

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45206

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43231

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73069

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Jenkintown

State/Province

Pennsylvania

ZIP/Postal Code

19046

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29209

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29572

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Franklin

State/Province

Tennessee

ZIP/Postal Code

37067

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37923

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38104

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78704

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Baytown

State/Province

Texas

ZIP/Postal Code

77521

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Beaumont

State/Province

Texas

ZIP/Postal Code

77702

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Corsicana

State/Province

Texas

ZIP/Postal Code

75110

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

DeSoto

State/Province

Texas

ZIP/Postal Code

75115

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77079

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77099

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

McAllen

State/Province

Texas

ZIP/Postal Code

78503

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Ogden

State/Province

Utah

ZIP/Postal Code

84405

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23320

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31243803

Citation

Auerbach M, Henry D, Derman RJ, Achebe MM, Thomsen LL, Glaspy J. A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial. Am J Hematol. 2019 Sep;94(9):1007-1014. doi: 10.1002/ajh.25564. Epub 2019 Jul 13.

Results Reference

result

Citation

Auerbach M and Lykke LL. A single infusion of iron isomaltoside 1000 allows a more rapid hemoglobin increment than multiple doses of iron sucrose with a similar safety profile in patients with iron deficiency anemia. Blood 2018 132:2334; doi: https://doi.org/10.1182/blood-2018-99-110199

Results Reference

result

Links:

URL

https://doi.org/10.1182/blood-2018-99-110199

Description

Efficacy and safety of a single infusion of iron isomaltoside/ferric derisomaltose versus multiple doses of iron sucrose

Learn more about this trial

Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)

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Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)

Iron Deficiency Anaemia, Iron Deficiency Anemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial