Iron Deficiency AnaemiaPhase 3NCT02940860

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

A Phase 3 study testing Iron isomaltoside/ferric derisomaltose and Iron sucrose in people with Iron Deficiency Anaemia and Iron Deficiency Anemia, run by Pharmacosmos A/S at 141 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Iron Deficiency Anaemia, Iron Deficiency Anemia, Chronic Kidney Disease
What is being tested?: Iron isomaltoside/ferric derisomaltose and Iron sucrose
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,538 participants
Where: 141 sitesUnited States
Study dates: 29 Nov 2016to 29 May 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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Decompensated liver cirrhosis or active hepatitis
Alcohol or drug abuse within the past 6 month.
Pregnant or nursing women.

Trial locations and contacts

141 sites in 1 country.

City, postcode or hospital

141 sites in 1 country

United States141 sites

Pharmacosmos Investigational Site
Albuquerque, New Mexico, 87109
Pharmacosmos Investigational Site
Annapolis, Maryland, 21401
Pharmacosmos Investigational Site
Arlington, Virginia, 22207
Pharmacosmos Investigational Site
Arvada, Colorado, 80002
Pharmacosmos Investigational Site
Asheville, North Carolina, 28801
Pharmacosmos Investigational Site
Atlanta, Georgia, 30342
Pharmacosmos Investigational Site
Augusta, Georgia, 30901
Pharmacosmos Investigational Site
Austin, Texas, 78758
Pharmacosmos Investigational Site
Baton Rouge, Louisiana, 70808
Pharmacosmos Investigational Site
Beaumont, Texas, 77702
Pharmacosmos Investigational Site
Bethesda, Maryland, 20817
Pharmacosmos Investigational Site
Bethlehem, Pennsylvania, 18107
Pharmacosmos Investigational Site
Boynton Beach, Florida, 33426
Pharmacosmos Investigational Site
Brandon, Florida, 33511
Pharmacosmos Investigational Site
Chicago, Illinois, 60611
Pharmacosmos Investigational Site
Chicago, Illinois, 60643
Pharmacosmos Investigational Site
Chula Vista, California, 91910
Pharmacosmos Investigational Site
Cincinnati, Ohio, 45206
Pharmacosmos Investigational Site
Cincinnati, Ohio, 45220
Pharmacosmos Investigational Site
Cleveland, Ohio, 44106
Pharmacosmos Investigational Site
Columbia, South Carolina, 29203
Pharmacosmos Investigational Site
Coral Gables, Florida, 33134
Pharmacosmos Investigational Site
Coral Springs, Florida, 33071
Pharmacosmos Investigational Site
Covington, Louisiana, 70433
Pharmacosmos Investigational Site
Crystal Lake, Illinois, 60012
Pharmacosmos Investigational Site
Denver, Colorado, 80218
Pharmacosmos Investigational Site
DeSoto, Texas, 75115
Pharmacosmos Investigational Site
Doral, Florida, 33166
Pharmacosmos Investigational Site
El Paso, Texas, 79935
Pharmacosmos Investigational Site
Fairfax, Virginia, 22033
Pharmacosmos Investigational Site
Florissant, Missouri, 63031
Pharmacosmos Investigational Site
Flushing, New York, 11355
Pharmacosmos Investigational Site
Fort Lauderdale, Florida, 33308
Pharmacosmos Investigational Site
Fort Wayne, Indiana, 48604
Pharmacosmos Investigational Site
Fort Worth, Texas, 76104
Pharmacosmos Investigational Site
Fresno, California, 93720
Pharmacosmos Investigational Site
Gastonia, North Carolina, 28054
Pharmacosmos Investigational Site
Glendale, California, 91204
Pharmacosmos Investigational Site
Glendale, California, 91206
Pharmacosmos Investigational Site
Granada Hills, California, 91344
Pharmacosmos Investigational Site
Grand Rapids, Michigan, 49525
Pharmacosmos Investigational Site
Greenville, North Carolina, 27834
Pharmacosmos Investigational Site
Greenville, South Carolina, 29605
Pharmacosmos Investigational Site
Greenville, Texas, 75401
Pharmacosmos Investigational Site1
Hialeah, Florida, 33012
Pharmacosmos Investigational Site2
Hialeah, Florida, 33012
Pharmacosmos Investigational Site3
Hialeah, Florida, 33012
Pharmacosmos Investigational Site
Hinsdale, Illinois, 60521
Pharmacosmos Investigational Site
Hollywood, Florida, 33024
Pharmacosmos Investigational Site
Homestead, Florida, 33030
Pharmacosmos Investigational Site1
Houston, Texas, 77030
Pharmacosmos Investigational Site2
Houston, Texas, 77030
Pharmacosmos Investigational Site
Houston, Texas, 77084
Pharmacosmos Investigational Site
Houston, Texas, 77089
Pharmacosmos Investigational Site1
Houston, Texas, 77099
Pharmacosmos Investigational Site2
Houston, Texas, 77099
Pharmacosmos Investigational Site
Huntsville, Alabama, 35805
Pharmacosmos Investigational Site
Jackson, Tennessee, 38305
Pharmacosmos Investigational Site
Jacksonville, North Carolina, 28546
Pharmacosmos Investigational Site
Kansas City, Kansas, 66160
Pharmacosmos Investigational Site
La Mesa, California, 91942
Pharmacosmos Investigational Site
Lake City, Florida, 32024
Pharmacosmos Investigational Site1
Lauderdale Lakes, Florida, 33313
Pharmacosmos Investigational Site2
Lauderdale Lakes, Florida, 33313
Pharmacosmos Investigational Site
Little Rock, Arkansas, 72204
Pharmacosmos Investigational Site
Little Rock, Arkansas, 72205
Pharmacosmos Investigational Site
Los Angeles, California, 90022
Pharmacosmos Investigational Site
Los Angeles, California, 90025
Pharmacosmos Investigational Site1
Los Angeles, California, 90048
Pharmacosmos Investigational Site2
Los Angeles, California, 90048
Pharmacosmos Investigational Site
Los Angeles, California, 90057
Pharmacosmos Investigational Site
Lufkin, Texas, 75904
Pharmacosmos Investigational Site
Lynwood, California, 90262
Pharmacosmos Investigational Site
Macon, Georgia, 31217
Pharmacosmos Investigational Site
Marion, Indiana, 46952
Pharmacosmos Investigational Site
McKinney, Texas, 75069
Pharmacosmos Investigational Site
Merrillville, Indiana, 46410
Pharmacosmos Investigational Site1
Miami, Florida, 33015
Pharmacosmos Investigational Site2
Miami, Florida, 33015
Pharmacosmos Investigational Site
Miami, Florida, 33126
Pharmacosmos Investigational Site
Miami, Florida, 33133
Pharmacosmos Investigational Site
Miami, Florida, 33135
Pharmacosmos Investigational Site1
Miami, Florida, 33144
Pharmacosmos Investigational Site2
Miami, Florida, 33144
Pharmacosmos Investigational Site3
Miami, Florida, 33144
Pharmacosmos Investigational Site1
Miami, Florida, 33145
Pharmacosmos Investigational Site2
Miami, Florida, 33145
Pharmacosmos Investigational Site3
Miami, Florida, 33145
Pharmacosmos Investigational Site
Miami, Florida, 33147
Pharmacosmos Investigational Site1
Miami, Florida, 33165
Pharmacosmos Investigational Site2
Miami, Florida, 33165
Pharmacosmos Investigational Site
Miami, Florida, 33172
Pharmacosmos Investigational Site
Miami, Florida, 33173
Pharmacosmos Investigational Site1
Miami, Florida, 33175
Pharmacosmos Investigational Site2
Miami, Florida, 33175
Pharmacosmos Investigational Site
Miami, Florida, 33176
Pharmacosmos Investigational Site
Miami, Florida, 33183
Pharmacosmos Investigational Site1
Miami, Florida, 33186
Pharmacosmos Investigational Site2
Miami, Florida, 33186
Pharmacosmos Investigational Site
Miami Beach, Florida, 33140
Pharmacosmos Investigational Site
Miami Lakes, Florida, 33014
Pharmacosmos Investigational Site
Michigan City, Indiana, 46360
Pharmacosmos Investigational Site
Middlebury, Connecticut, 06762
Pharmacosmos Investigational Site
Montebello, California, 90640
Pharmacosmos Investigational Site
Naples, Florida, 34102
Pharmacosmos Investigational Site
New York, New York, 10010
Pharmacosmos Investigational Site
New York, New York, 10016
Pharmacosmos Investigational Site
Norman, Oklahoma, 73069
Pharmacosmos Investigational Site
Northridge, California, 31324
Pharmacosmos Investigational Site
Northridge, California, 91324
Pharmacosmos Investigational Site
Ocala, Florida, 34471
Pharmacosmos Investigational Site
Orangeburg, South Carolina, 29118
Pharmacosmos Investigational Site
Owensboro, Kentucky, 42301
Pharmacosmos Investigational Site
Palmetto Bay, Florida, 33157
Pharmacosmos Investigational Site
Pearland, Texas, 77581
Pharmacosmos Investigational Site
Pembroke Pines, Florida, 33026
Pharmacosmos Investigational Site
Philadelphia, Pennsylvania, 19140
Pharmacosmos Investigational Site
Plainville, Connecticut, 06062
Pharmacosmos Investigational Site
Plantation, Florida, 33322
Pharmacosmos Investigational Site
Port Charlotte, Florida, 33952
Pharmacosmos Investigational Site
Porterville, California, 93257
Pharmacosmos Investigational Site
Rialto, California, 92377
Pharmacosmos Investigational Site
Riverside, California, 92505
Pharmacosmos Investigational Site
Rockville, Maryland, 20852
Pharmacosmos Investigational Site
Sacramento, California, 95825
Pharmacosmos Investigational Site1
San Antonio, Texas, 78215
Pharmacosmos Investigational Site2
San Antonio, Texas, 78215
Pharmacosmos Investigational Site
San Dimas, California, 91773
Pharmacosmos Investigational Site
San Francisco, California, 94110
Pharmacosmos Investigational Site
Shreveport, Louisiana, 71101
Pharmacosmos Investigational Site
St. George, Utah, 84790
Pharmacosmos Investigational Site
St. Petersburg, Florida, 33713
Pharmacosmos Investigational Site1
Tampa, Florida, 33607
Pharmacosmos Investigational Site2
Tampa, Florida, 33607
Pharmacosmos Investigational Site
Tampa, Florida, 33614
Pharmacosmos Investigational Site
Tarzana, California, 91356
Pharmacosmos Investigational Site
Tulsa, Oklahoma, 74136
Pharmacosmos Investigational Site
West Miami, Florida, 33144
Pharmacosmos Investigational Site
Westminster, Colorado, 80031
Pharmacosmos Investigational Site
Wichita, Kansas, 67214
Pharmacosmos Investigational Site
Wilmington, North Carolina, 28401

Other trials in United States

About this study

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)

Read the 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.

Conditions: Iron Deficiency Anaemia, Iron Deficiency Anemia, Chronic Kidney Disease
Being tested: Iron isomaltoside/ferric derisomaltose, Iron sucrose
Keywords: Iron Deficiency Anaemia, Iron Deficiency Anemia, IDA, Chronic Kidney Disease, CKD, Iron isomaltoside, Ferric derisomaltose, Monofer, Monoferric, Monover, Monofar, Monoferro
Medical subject headings: Anemia, Iron-Deficiency, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Iron isomaltoside/ferric derisomaltoseDrug
Also called Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®
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.
Iron sucroseDrug
Also called Venofer®
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.

Study groups in NCT02940860
Study group	Role	What they receive
Iron isomaltoside/ferric derisomaltose	Experimental	Administered IV Receives: Drug: Iron isomaltoside/ferric derisomaltose
Iron sucrose	Active comparator	Administered IV Receives: Drug: Iron sucrose

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to week 8
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.
Measured: Baseline to week 8

Secondary outcomes (18)

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.
Measured: Baseline, week 1, 2, and 8
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.
Measured: Baseline, week 1, 2, 4, and 8
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.
Measured: Baseline, week 1, 2, 4, and 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).
Measured: Baseline, 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.
Measured: Baseline, week 1, 2, 4, and 8
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.
Measured: 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.
Measured: 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.
Measured: Week 1 to week 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.
Measured: Baseline, 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.
Measured: Baseline, week 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.
Measured: Baseline, 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.
Measured: Baseline, 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
Measured: Baseline, week 1, 2, and 8
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).
Measured: Baseline
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car
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).
Measured: Baseline
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit
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).
Measured: Baseline
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits
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).
Measured: Baseline
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).
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Nov 201629 May 2018

First posted21 Oct 2016 (estimated)
Study start29 Nov 2016
Primary completion29 May 2018
Study completion29 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Iron Deficiency AnaemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,538 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02940860
Sponsor's protocol ID: P-Monofer-CKD-04
Status last verified: Feb 2020
First submitted: 27 Sep 2016
Last updated: 6 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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
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.
PubMed 32049331

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Iron Deficiencies
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Enrolling by invitationObservational study
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Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02940860
Acronym / sponsor ID: P-Monofer-CKD-04
Conditions: 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
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,538 participants (actual)
Lead sponsor: Pharmacosmos A/SIndustry (pharma, biotech, devices)
Study start: 29 Nov 2016 (actual)
Primary completion: 29 May 2018 (actual)
Study completion: 29 May 2018 (actual)
First posted: 21 Oct 2016 (estimated)
Results: Posted 6 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Iron isomaltoside/ferric derisomaltose	Experimental	Drug: Iron isomaltoside/ferric derisomaltoseAdministered IV
Iron sucrose	Active comparator	Drug: Iron sucroseAdministered IV

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Iron isomaltoside/ferric derisomaltoseAlso: Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®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.	Drug	Iron isomaltoside/ferric derisomaltose
Iron sucroseAlso: Venofer®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.	Drug	Iron sucrose

Primary outcome

Change in Hemoglobin (Hb) From Baseline to Week 8
Time frame: 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
Time frame: Baseline to week 8
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.

18 secondary outcomes

Composite Cardiovascular Adverse Events (AEs)
Time frame: Baseline, week 1, 2, and 8
Time to First Composite Cardiovascular Safety AE
Time frame: Baseline, week 1, 2, 4, and 8
S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8
Time frame: Baseline, week 1, 2, 4, and 8
Hb Concentration Increase of ≥1 g/dL From Baseline to Week 1, 2, 4, and 8
Time frame: Baseline, week 1, 2, 4, and 8
Time to Change in Hb Concentration ≥1 g/dL
Time frame: Baseline, week 1, 2, 4, and 8
Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8
Time frame: Week 1 to week 8
Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8
Time frame: 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
Time frame: Week 1 to week 8
Change in Hb Concentration From Baseline to Week 1, 2, and 4
Time frame: Baseline, week 1, 2, and 4
Change in S-ferritin From Baseline to Weeks 1, 2, 4, and 8
Time frame: Baseline, week 1, 2, 4, and 8
Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8
Time frame: Baseline, week 1, 2, 4, and 8
Change in Concentration of S-iron From Baseline to Week 1, 2, 4, and 8
Time frame: Baseline, week 1, 2, 4, and 8
Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8
Time frame: Baseline, week 1, 2, and 8
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking
Time frame: Baseline
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car
Time frame: Baseline
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit
Time frame: Baseline
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits
Time frame: Baseline
Health Care Resource Use Questionnaire
Time frame: Baseline

Results and safety

Results posted to the registry on 6 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Iron Isomaltoside/Ferric Derisomaltose	1,027	971
Iron Sucrose	511	476

Primary outcome: Change in Hemoglobin (Hb) From Baseline to Week 8

Time frame: Baseline to week 8. Least squares mean (95% Confidence Interval). Unit: g/dL

Measure	Iron Isomaltoside/Ferric Derisomaltose n = 1027	Iron Sucrose n = 511
Value	1.22 (1.14 to 1.31)	1.14 (1.03 to 1.26)

Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose: Mean Difference (Final Values): 0.08 (95% CI -0.06 to 0.23)

Population analysed: Intention to treat (ITT). All randomised subjects.

Primary outcome: Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions

Time frame: Baseline to week 8. Count of participants. Unit: Participants

Measure	Iron Isomaltoside/Ferric Derisomaltose n = 1019	Iron Sucrose n = 506
Value	3	0

Iron Isomaltoside/Ferric Derisomaltose: 95% two-sided CI (iron isomaltoside): 0.3 (95% CI 0.06 to 0.86)
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose: Risk Difference (RD): 0.29 (95% CI -0.19 to 0.77)
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose: Risk Difference (RD): 0.10 (95% CI -0.57 to 0.48)

Population analysed: Safety analysis set. All randomised subjects who received at least one dose of the investigational product.

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time a subjects had signed the informed consent form (CRF) and until they had completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 8 weeks (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 10 weeks (including a 14-day screening period).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Iron Isomaltoside/Ferric Derisomaltose	83 of 1,019 (8.1%)	56 of 1,019 (5.5%)	3 of 1,019
Iron Sucrose	50 of 506 (9.9%)	34 of 506 (6.7%)	3 of 506

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationSunil 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
Derived from this study: PubMed 32049331Bhandari 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pharmacosmos A/S Clinical and Non-clinical Research study director

Pharmacosmos A/S

141 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hemoglobin (Hb) From Baseline to Week 8 (time frame: Baseline to week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02940860, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.