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Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease

Primary Purpose

Iron Deficiency Anaemia, Iron Deficiency Anemia, Chronic Kidney Disease

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, Chronic Kidney Disease, CKD, 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 and women, ≥ 18 years
Hb ≤ 11 g/dL
Chronic renal impairment, as defined by either (i) eGFR < 60 mL/min/1.73m2 at screening (as calculated by modification of diet in renal disease (MDRD)), or (ii) Estimated Glomerular Filtration Rate (eGFR) < 90 mL/min/1.73m2 at screening and kidney damage as indicated by abnormalities in urine composition per medical history and/or intermediate/high risk of cardio-vascular disease based on the Framingham model
Screening s-ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL if Transferrin Saturation (TSAT) ≤ 30 %
Either no Erythropoiesis Stimulating Agent (ESAs) or ESAs as a stable dose 4 weeks before randomisation
Willingness to participate and signing the informed consent form

Exclusion Criteria includes:

Anaemia predominantly caused by factors other than IDA
Hemochromatosis or other iron storage disorders
Previous serious hypersensitivity reactions to any IV iron compounds
Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
Undergoing dialysis for treatment of CKD
Planned surgical procedure within the trial period
Decompensated liver cirrhosis or active hepatitis
Alcohol or drug abuse within the past 6 month.
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 of iron isomaltoside/ferric derisomaltose vs iron sucrose in subjects with non-dialysis-dependent chronic kidney disease (NDD-CKD) and 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 NDD-CKD and IDA, when oral iron preparations were ineffective or could not be used, or in whom the Hb measurement at screening 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 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 participants who had s-phosphate <2 mg/dL at any time from baseline to week 1, 2, 4, or 8.

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

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

Time to Change in Hb Concentration ≥1 g/dL

Efficacy Time to change in Hb concentration ≥1 g/dL. Subjects who showed Hb concentration increase of ≥1 g/dL (from baseline to week 1, 2, 4, and 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 From Baseline to Weeks 1, 2, 4, and 8

Efficacy Changes in s-ferritin 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.

Change in Concentration of 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 2 treatment groups is different (i.e. up to a factor 5 more frequent in the iron sucrose treatment group).

Full Information

NCT ID

NCT02940860

First Posted

September 27, 2016

Last Updated

September 15, 2020

Sponsor

Pharmacosmos A/S

1. Study Identification

Unique Protocol Identification Number

NCT02940860

Brief Title

Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease

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 Anaemia and Non-dialysis-dependent Chronic Kidney Disease (FERWON-NEPHRO)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

November 29, 2016 (Actual)

Primary Completion Date

May 29, 2018 (Actual)

Study Completion Date

May 29, 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

Evaluation of safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose, in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).

Detailed Description

Iron deficiency anaemia (IDA) is a common problem associated with many chronic diseases such as chronic kidney disease (CKD). IDA can have a substantial medical and quality of life (QoL) burden on the subjects. Therapy of these subjects includes treating the underlying cause of IDA and restoring haemoglobin (Hb) concentration and iron stores. This study evaluated the safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA). 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, Chronic Kidney Disease

Keywords

Iron Deficiency Anaemia, Iron Deficiency Anemia, IDA, Chronic Kidney Disease, CKD, 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

1538 (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 participants 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 ≥1 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 ≥1 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 From Baseline to Weeks 1, 2, 4, and 8

Description

Efficacy Changes in s-ferritin 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

Efficacy Changes in transferrin saturation (TSAT) from baseline to week 1, 2, 4, and 8.

Time Frame

Baseline, week 1, 2, 4, and 8

Title

Change in Concentration of 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 and women, ≥ 18 years Hb ≤ 11 g/dL Chronic renal impairment, as defined by either (i) eGFR < 60 mL/min/1.73m2 at screening (as calculated by modification of diet in renal disease (MDRD)), or (ii) Estimated Glomerular Filtration Rate (eGFR) < 90 mL/min/1.73m2 at screening and kidney damage as indicated by abnormalities in urine composition per medical history and/or intermediate/high risk of cardio-vascular disease based on the Framingham model Screening s-ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL if Transferrin Saturation (TSAT) ≤ 30 % Either no Erythropoiesis Stimulating Agent (ESAs) or ESAs as a stable dose 4 weeks before randomisation Willingness to participate and signing the informed consent form Exclusion Criteria includes: Anaemia predominantly caused by factors other than IDA Hemochromatosis or other iron storage disorders Previous serious hypersensitivity reactions to any IV iron compounds Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy Undergoing dialysis for treatment of CKD Planned surgical procedure within the trial period Decompensated liver cirrhosis or active hepatitis Alcohol or drug abuse within the past 6 month. 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

Huntsville

State/Province

Alabama

ZIP/Postal Code

35805

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

Chula Vista

State/Province

California

ZIP/Postal Code

91910

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Glendale

State/Province

California

ZIP/Postal Code

91204

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Glendale

State/Province

California

ZIP/Postal Code

91206

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Granada Hills

State/Province

California

ZIP/Postal Code

91344

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90022

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Pharmacosmos Investigational Site1

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Pharmacosmos Investigational Site2

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Lynwood

State/Province

California

ZIP/Postal Code

90262

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Montebello

State/Province

California

ZIP/Postal Code

90640

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Northridge

State/Province

California

ZIP/Postal Code

31324

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Porterville

State/Province

California

ZIP/Postal Code

93257

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

92505

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95825

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

San Dimas

State/Province

California

ZIP/Postal Code

91773

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94110

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Tarzana

State/Province

California

ZIP/Postal Code

91356

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Arvada

State/Province

Colorado

ZIP/Postal Code

80002

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Westminster

State/Province

Colorado

ZIP/Postal Code

80031

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Middlebury

State/Province

Connecticut

ZIP/Postal Code

06762

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

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33426

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Coral Springs

State/Province

Florida

ZIP/Postal Code

33071

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Doral

State/Province

Florida

ZIP/Postal Code

33166

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 Site1

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Pharmacosmos Investigational Site2

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Pharmacosmos Investigational Site3

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

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

Homestead

State/Province

Florida

ZIP/Postal Code

33030

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 Site1

City

Lauderdale Lakes

State/Province

Florida

ZIP/Postal Code

33313

Country

United States

Facility Name

Pharmacosmos Investigational Site2

City

Lauderdale Lakes

State/Province

Florida

ZIP/Postal Code

33313

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

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 Site1

City

Miami

State/Province

Florida

ZIP/Postal Code

33015

Country

United States

Facility Name

Pharmacosmos Investigational Site2

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

33133

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Pharmacosmos Investigational Site1

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Pharmacosmos Investigational Site2

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Pharmacosmos Investigational Site3

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Pharmacosmos Investigational Site1

City

Miami

State/Province

Florida

ZIP/Postal Code

33145

Country

United States

Facility Name

Pharmacosmos Investigational Site2

City

Miami

State/Province

Florida

ZIP/Postal Code

33145

Country

United States

Facility Name

Pharmacosmos Investigational Site3

City

Miami

State/Province

Florida

ZIP/Postal Code

33145

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33147

Country

United States

Facility Name

Pharmacosmos Investigational Site1

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

Pharmacosmos Investigational Site2

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

33172

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

Pharmacosmos Investigational Site1

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

Pharmacosmos Investigational Site2

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33183

Country

United States

Facility Name

Pharmacosmos Investigational Site1

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Facility Name

Pharmacosmos Investigational Site2

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

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

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33026

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Plantation

State/Province

Florida

ZIP/Postal Code

33322

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33713

Country

United States

Facility Name

Pharmacosmos Investigational Site1

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Facility Name

Pharmacosmos Investigational Site2

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

W. Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30901

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Macon

State/Province

Georgia

ZIP/Postal Code

31217

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60643

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Crystal Lake

State/Province

Illinois

ZIP/Postal Code

60012

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Hinsdale

State/Province

Illinois

ZIP/Postal Code

60521

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

48604

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Marion

State/Province

Indiana

ZIP/Postal Code

46952

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Merrillville

State/Province

Indiana

ZIP/Postal Code

46410

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Michigan City

State/Province

Indiana

ZIP/Postal Code

46360

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

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

42301

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Covington

State/Province

Louisiana

ZIP/Postal Code

70433

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Annapolis

State/Province

Maryland

ZIP/Postal Code

21401

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

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

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

Florissant

State/Province

Missouri

ZIP/Postal Code

63031

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Flushing

State/Province

New York

ZIP/Postal Code

11355

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10010

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

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Gastonia

State/Province

North Carolina

ZIP/Postal Code

28054

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Jacksonville

State/Province

North Carolina

ZIP/Postal Code

28546

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

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45206

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45220

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

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

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18107

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29203

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Orangeburg

State/Province

South Carolina

ZIP/Postal Code

29118

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78758

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

DeSoto

State/Province

Texas

ZIP/Postal Code

75115

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79935

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Greenville

State/Province

Texas

ZIP/Postal Code

75401

Country

United States

Facility Name

Pharmacosmos Investigational Site1

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Pharmacosmos Investigational Site2

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

77084

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77089

Country

United States

Facility Name

Pharmacosmos Investigational Site1

City

Houston

State/Province

Texas

ZIP/Postal Code

77099

Country

United States

Facility Name

Pharmacosmos Investigational Site2

City

Houston

State/Province

Texas

ZIP/Postal Code

77099

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Lufkin

State/Province

Texas

ZIP/Postal Code

75904

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

McKinney

State/Province

Texas

ZIP/Postal Code

75069

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Pearland

State/Province

Texas

ZIP/Postal Code

77581

Country

United States

Facility Name

Pharmacosmos Investigational Site1

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

Pharmacosmos Investigational Site2

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Saint George

State/Province

Utah

ZIP/Postal Code

84790

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22207

Country

United States

Facility Name

Pharmacosmos Investigational Site

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22033

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

Sunil Bhandari, Lars Lykke Thomsen. Single 1000 mg infusion of iron isomaltoside1000 single 1000 mg infusion of iron isomaltoside 1000 demonstrates a more rapid hemoglobin response and reduced risk of cardiovascular adverse events compared to multiple dose iron sucrose In patients with iron deficiency anemia and nondialysis-dependent CKD. Nephrology Dialysis Transplantation 34 (Supplement 1): i349-i350, 2019, https://academic.oup.com/ndt/article/34/Supplement_1/gfz101.SaO035/5515662

Results Reference

result

PubMed Identifier

32049331

Citation

Bhandari S, Kalra PA, Berkowitz M, Belo D, Thomsen LL, Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial. Nephrol Dial Transplant. 2021 Jan 1;36(1):111-120. doi: 10.1093/ndt/gfaa011.

Results Reference

derived

Links:

URL

http://academic.oup.com/ndt/article/34/Supplement_1/gfz101.SaO035/5515662

Description

The FERWON-NEPHRO trial; comparison of iron isomaltoside/ferric derisomaltose versus iron sucrose in NDD-CKD patients with iron deficiency anemia

Learn more about this trial

Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease

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Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease

Iron Deficiency Anaemia, Iron Deficiency Anemia, Chronic Kidney Disease

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