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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02940860
Other study ID # P-Monofer-CKD-04
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 29, 2016
Est. completion date May 29, 2018

Study information

Verified date February 2020
Source Pharmacosmos A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 1538
Est. completion date May 29, 2018
Est. primary completion date May 29, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
United States Pharmacosmos Investigational Site Albuquerque New Mexico
United States Pharmacosmos Investigational Site Annapolis Maryland
United States Pharmacosmos Investigational Site Arlington Virginia
United States Pharmacosmos Investigational Site Arvada Colorado
United States Pharmacosmos Investigational Site Asheville North Carolina
United States Pharmacosmos Investigational Site Atlanta Georgia
United States Pharmacosmos Investigational Site Augusta Georgia
United States Pharmacosmos Investigational Site Austin Texas
United States Pharmacosmos Investigational Site Baton Rouge Louisiana
United States Pharmacosmos Investigational Site Beaumont Texas
United States Pharmacosmos Investigational Site Bethesda Maryland
United States Pharmacosmos Investigational Site Bethlehem Pennsylvania
United States Pharmacosmos Investigational Site Boynton Beach Florida
United States Pharmacosmos Investigational Site Brandon Florida
United States Pharmacosmos Investigational Site Chicago Illinois
United States Pharmacosmos Investigational Site Chicago Illinois
United States Pharmacosmos Investigational Site Chula Vista California
United States Pharmacosmos Investigational Site Cincinnati Ohio
United States Pharmacosmos Investigational Site Cincinnati Ohio
United States Pharmacosmos Investigational Site Cleveland Ohio
United States Pharmacosmos Investigational Site Columbia South Carolina
United States Pharmacosmos Investigational Site Coral Gables Florida
United States Pharmacosmos Investigational Site Coral Springs Florida
United States Pharmacosmos Investigational Site Covington Louisiana
United States Pharmacosmos Investigational Site Crystal Lake Illinois
United States Pharmacosmos Investigational Site Denver Colorado
United States Pharmacosmos Investigational Site DeSoto Texas
United States Pharmacosmos Investigational Site Doral Florida
United States Pharmacosmos Investigational Site El Paso Texas
United States Pharmacosmos Investigational Site Fairfax Virginia
United States Pharmacosmos Investigational Site Florissant Missouri
United States Pharmacosmos Investigational Site Flushing New York
United States Pharmacosmos Investigational Site Fort Lauderdale Florida
United States Pharmacosmos Investigational Site Fort Wayne Indiana
United States Pharmacosmos Investigational Site Fort Worth Texas
United States Pharmacosmos Investigational Site Fresno California
United States Pharmacosmos Investigational Site Gastonia North Carolina
United States Pharmacosmos Investigational Site Glendale California
United States Pharmacosmos Investigational Site Glendale California
United States Pharmacosmos Investigational Site Granada Hills California
United States Pharmacosmos Investigational Site Grand Rapids Michigan
United States Pharmacosmos Investigational Site Greenville North Carolina
United States Pharmacosmos Investigational Site Greenville South Carolina
United States Pharmacosmos Investigational Site Greenville Texas
United States Pharmacosmos Investigational Site1 Hialeah Florida
United States Pharmacosmos Investigational Site2 Hialeah Florida
United States Pharmacosmos Investigational Site3 Hialeah Florida
United States Pharmacosmos Investigational Site Hinsdale Illinois
United States Pharmacosmos Investigational Site Hollywood Florida
United States Pharmacosmos Investigational Site Homestead Florida
United States Pharmacosmos Investigational Site Houston Texas
United States Pharmacosmos Investigational Site Houston Texas
United States Pharmacosmos Investigational Site1 Houston Texas
United States Pharmacosmos Investigational Site1 Houston Texas
United States Pharmacosmos Investigational Site2 Houston Texas
United States Pharmacosmos Investigational Site2 Houston Texas
United States Pharmacosmos Investigational Site Huntsville Alabama
United States Pharmacosmos Investigational Site Jackson Tennessee
United States Pharmacosmos Investigational Site Jacksonville North Carolina
United States Pharmacosmos Investigational Site Kansas City Kansas
United States Pharmacosmos Investigational Site La Mesa California
United States Pharmacosmos Investigational Site Lake City Florida
United States Pharmacosmos Investigational Site1 Lauderdale Lakes Florida
United States Pharmacosmos Investigational Site2 Lauderdale Lakes Florida
United States Pharmacosmos Investigational Site Little Rock Arkansas
United States Pharmacosmos Investigational Site Little Rock Arkansas
United States Pharmacosmos Investigational Site Los Angeles California
United States Pharmacosmos Investigational Site Los Angeles California
United States Pharmacosmos Investigational Site Los Angeles California
United States Pharmacosmos Investigational Site1 Los Angeles California
United States Pharmacosmos Investigational Site2 Los Angeles California
United States Pharmacosmos Investigational Site Lufkin Texas
United States Pharmacosmos Investigational Site Lynwood California
United States Pharmacosmos Investigational Site Macon Georgia
United States Pharmacosmos Investigational Site Marion Indiana
United States Pharmacosmos Investigational Site McKinney Texas
United States Pharmacosmos Investigational Site Merrillville Indiana
United States Pharmacosmos Investigational Site Miami Florida
United States Pharmacosmos Investigational Site Miami Florida
United States Pharmacosmos Investigational Site Miami Florida
United States Pharmacosmos Investigational Site Miami Florida
United States Pharmacosmos Investigational Site Miami Florida
United States Pharmacosmos Investigational Site Miami Florida
United States Pharmacosmos Investigational Site Miami Florida
United States Pharmacosmos Investigational Site Miami Florida
United States Pharmacosmos Investigational Site1 Miami Florida
United States Pharmacosmos Investigational Site1 Miami Florida
United States Pharmacosmos Investigational Site1 Miami Florida
United States Pharmacosmos Investigational Site1 Miami Florida
United States Pharmacosmos Investigational Site1 Miami Florida
United States Pharmacosmos Investigational Site1 Miami Florida
United States Pharmacosmos Investigational Site2 Miami Florida
United States Pharmacosmos Investigational Site2 Miami Florida
United States Pharmacosmos Investigational Site2 Miami Florida
United States Pharmacosmos Investigational Site2 Miami Florida
United States Pharmacosmos Investigational Site2 Miami Florida
United States Pharmacosmos Investigational Site2 Miami Florida
United States Pharmacosmos Investigational Site3 Miami Florida
United States Pharmacosmos Investigational Site3 Miami Florida
United States Pharmacosmos Investigational Site Miami Beach Florida
United States Pharmacosmos Investigational Site Miami Lakes Florida
United States Pharmacosmos Investigational Site Michigan City Indiana
United States Pharmacosmos Investigational Site Middlebury Connecticut
United States Pharmacosmos Investigational Site Montebello California
United States Pharmacosmos Investigational Site Naples Florida
United States Pharmacosmos Investigational Site New York New York
United States Pharmacosmos Investigational Site New York New York
United States Pharmacosmos Investigational Site Norman Oklahoma
United States Pharmacosmos Investigational Site Northridge California
United States Pharmacosmos Investigational Site Northridge California
United States Pharmacosmos Investigational Site Ocala Florida
United States Pharmacosmos Investigational Site Orangeburg South Carolina
United States Pharmacosmos Investigational Site Owensboro Kentucky
United States Pharmacosmos Investigational Site Palmetto Bay Florida
United States Pharmacosmos Investigational Site Pearland Texas
United States Pharmacosmos Investigational Site Pembroke Pines Florida
United States Pharmacosmos Investigational Site Philadelphia Pennsylvania
United States Pharmacosmos Investigational Site Plainville Connecticut
United States Pharmacosmos Investigational Site Plantation Florida
United States Pharmacosmos Investigational Site Port Charlotte Florida
United States Pharmacosmos Investigational Site Porterville California
United States Pharmacosmos Investigational Site Rialto California
United States Pharmacosmos Investigational Site Riverside California
United States Pharmacosmos Investigational Site Rockville Maryland
United States Pharmacosmos Investigational Site Sacramento California
United States Pharmacosmos Investigational Site Saint George Utah
United States Pharmacosmos Investigational Site Saint Petersburg Florida
United States Pharmacosmos Investigational Site1 San Antonio Texas
United States Pharmacosmos Investigational Site2 San Antonio Texas
United States Pharmacosmos Investigational Site San Dimas California
United States Pharmacosmos Investigational Site San Francisco California
United States Pharmacosmos Investigational Site Shreveport Louisiana
United States Pharmacosmos Investigational Site Tampa Florida
United States Pharmacosmos Investigational Site1 Tampa Florida
United States Pharmacosmos Investigational Site2 Tampa Florida
United States Pharmacosmos Investigational Site Tarzana California
United States Pharmacosmos Investigational Site Tulsa Oklahoma
United States Pharmacosmos Investigational Site W. Miami Florida
United States Pharmacosmos Investigational Site Westminster Colorado
United States Pharmacosmos Investigational Site Wichita Kansas
United States Pharmacosmos Investigational Site Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Pharmacosmos A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 dos

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Baseline to week 8
Primary 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.
Baseline to week 8
Secondary 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.
Baseline, week 1, 2, and 8
Secondary 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.
Baseline, week 1, 2, 4, and 8
Secondary 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.
Baseline, week 1, 2, 4, and 8
Secondary 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).
Baseline, week 1, 2, 4, and 8
Secondary 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.
Baseline, week 1, 2, 4, and 8
Secondary 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.
Week 1 to week 8
Secondary 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.
Week 1 to week 8
Secondary 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.
Week 1 to week 8
Secondary 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.
Baseline, week 1, 2, and 4
Secondary 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.
Baseline, week 1, 2, 4, and 8
Secondary 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.
Baseline, week 1, 2, 4, and 8
Secondary 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.
Baseline, week 1, 2, 4, and 8
Secondary 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
Baseline, week 1, 2, and 8
Secondary 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).
Baseline
Secondary 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).
Baseline
Secondary 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).
Baseline
Secondary 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).
Baseline
Secondary 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).
Baseline
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