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

September 15, 2020 updated by: Pharmacosmos A/S

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1538

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria includes:

  1. Men and women, ≥ 18 years
  2. Hb ≤ 11 g/dL
  3. 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
  4. Screening s-ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL if Transferrin Saturation (TSAT) ≤ 30 %
  5. Either no Erythropoiesis Stimulating Agent (ESAs) or ESAs as a stable dose 4 weeks before randomisation
  6. Willingness to participate and signing the informed consent form

Exclusion Criteria includes:

  1. Anaemia predominantly caused by factors other than IDA
  2. Hemochromatosis or other iron storage disorders
  3. Previous serious hypersensitivity reactions to any IV iron compounds
  4. Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
  5. Undergoing dialysis for treatment of CKD
  6. Planned surgical procedure within the trial period
  7. Decompensated liver cirrhosis or active hepatitis
  8. Alcohol or drug abuse within the past 6 month.
  9. Pregnant or nursing women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iron isomaltoside/ferric derisomaltose
Administered IV
Drug: Iron isomaltoside/ferric derisomaltose

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.

Other Names:
  • Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®
Active Comparator: Iron sucrose
Administered IV
Drug: Iron sucrose
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.
Other Names:
  • Venofer®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to week 8
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.
Baseline to week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Cardiovascular Adverse Events (AEs)
Time Frame: Baseline, week 1, 2, and 8

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.
Baseline, week 1, 2, and 8
Time to First Composite Cardiovascular Safety AE
Time Frame: Baseline, week 1, 2, 4, and 8

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.
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

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.
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

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).
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

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.
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

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.
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

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.
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

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.
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

Efficacy

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

Efficacy

Changes in s-ferritin from baseline to weeks 1, 2, 4, and 8.
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

Efficacy

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

Efficacy

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

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
Baseline, week 1, 2, and 8
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking
Time Frame: Baseline

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).
Baseline
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car
Time Frame: Baseline

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

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

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).
Baseline
Health Care Resource Use Questionnaire
Time Frame: Baseline

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).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmacosmos A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2016

Primary Completion (Actual)

May 29, 2018

Study Completion (Actual)

May 29, 2018

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-Monofer-CKD-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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