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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron isomaltoside/ferric derisomaltose | Experimental | Administered IV |
|
| Iron sucrose | Active Comparator | Administered IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron isomaltoside/ferric derisomaltose | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs. |
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Inclusion Criteria includes:
Exclusion Criteria includes:
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| Name | Affiliation | Role |
|---|---|---|
| Pharmacosmos A/S Clinical and Non-clinical Research | Pharmacosmos A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmacosmos Investigational Site | Huntsville | Alabama | 35805 | United States | ||
| Pharmacosmos Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 | ||
| 32049331 | Derived | 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. |
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A total of 2560 subjects were screened and 1538 subjects were randomised into the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iron Isomaltoside/Ferric Derisomaltose | Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial. Subjects received iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) as a single IV infusion of 1000 mg at the baseline visit. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 14, 2017 | Jan 6, 2020 |
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|
| Iron sucrose | Drug | 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. |
|
|
| 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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). | 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). | 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). | 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). | 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). | Baseline |
| Little Rock |
| Arkansas |
| 72204 |
| United States |
| Pharmacosmos Investigational Site | Little Rock | Arkansas | 72205 | United States |
| Pharmacosmos Investigational Site | Chula Vista | California | 91910 | United States |
| Pharmacosmos Investigational Site | Fresno | California | 93720 | United States |
| Pharmacosmos Investigational Site | Glendale | California | 91204 | United States |
| Pharmacosmos Investigational Site | Glendale | California | 91206 | United States |
| Pharmacosmos Investigational Site | Granada Hills | California | 91344 | United States |
| Pharmacosmos Investigational Site | La Mesa | California | 91942 | United States |
| Pharmacosmos Investigational Site | Los Angeles | California | 90022 | United States |
| Pharmacosmos Investigational Site | Los Angeles | California | 90025 | United States |
| Pharmacosmos Investigational Site1 | Los Angeles | California | 90048 | United States |
| Pharmacosmos Investigational Site2 | Los Angeles | California | 90048 | United States |
| Pharmacosmos Investigational Site | Los Angeles | California | 90057 | United States |
| Pharmacosmos Investigational Site | Lynwood | California | 90262 | United States |
| Pharmacosmos Investigational Site | Montebello | California | 90640 | United States |
| Pharmacosmos Investigational Site | Northridge | California | 31324 | United States |
| Pharmacosmos Investigational Site | Northridge | California | 91324 | United States |
| Pharmacosmos Investigational Site | Porterville | California | 93257 | United States |
| Pharmacosmos Investigational Site | Rialto | California | 92377 | United States |
| Pharmacosmos Investigational Site | Riverside | California | 92505 | United States |
| Pharmacosmos Investigational Site | Sacramento | California | 95825 | United States |
| Pharmacosmos Investigational Site | San Dimas | California | 91773 | United States |
| Pharmacosmos Investigational Site | San Francisco | California | 94110 | United States |
| Pharmacosmos Investigational Site | Tarzana | California | 91356 | United States |
| Pharmacosmos Investigational Site | Arvada | Colorado | 80002 | United States |
| Pharmacosmos Investigational Site | Denver | Colorado | 80218 | United States |
| Pharmacosmos Investigational Site | Westminster | Colorado | 80031 | United States |
| Pharmacosmos Investigational Site | Middlebury | Connecticut | 06762 | United States |
| Pharmacosmos Investigational Site | Plainville | Connecticut | 06062 | United States |
| Pharmacosmos Investigational Site | Boynton Beach | Florida | 33426 | United States |
| Pharmacosmos Investigational Site | Brandon | Florida | 33511 | United States |
| Pharmacosmos Investigational Site | Coral Gables | Florida | 33134 | United States |
| Pharmacosmos Investigational Site | Coral Springs | Florida | 33071 | United States |
| Pharmacosmos Investigational Site | Doral | Florida | 33166 | United States |
| Pharmacosmos Investigational Site | Fort Lauderdale | Florida | 33308 | United States |
| Pharmacosmos Investigational Site1 | Hialeah | Florida | 33012 | United States |
| Pharmacosmos Investigational Site2 | Hialeah | Florida | 33012 | United States |
| Pharmacosmos Investigational Site3 | Hialeah | Florida | 33012 | United States |
| Pharmacosmos Investigational Site | Hollywood | Florida | 33024 | United States |
| Pharmacosmos Investigational Site | Homestead | Florida | 33030 | United States |
| Pharmacosmos Investigational Site | Lake City | Florida | 32024 | United States |
| Pharmacosmos Investigational Site1 | Lauderdale Lakes | Florida | 33313 | United States |
| Pharmacosmos Investigational Site2 | Lauderdale Lakes | Florida | 33313 | United States |
| Pharmacosmos Investigational Site1 | Miami | Florida | 33015 | United States |
| Pharmacosmos Investigational Site2 | Miami | Florida | 33015 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33126 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33133 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33135 | United States |
| Pharmacosmos Investigational Site1 | Miami | Florida | 33144 | United States |
| Pharmacosmos Investigational Site2 | Miami | Florida | 33144 | United States |
| Pharmacosmos Investigational Site3 | Miami | Florida | 33144 | United States |
| Pharmacosmos Investigational Site1 | Miami | Florida | 33145 | United States |
| Pharmacosmos Investigational Site2 | Miami | Florida | 33145 | United States |
| Pharmacosmos Investigational Site3 | Miami | Florida | 33145 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33147 | United States |
| Pharmacosmos Investigational Site1 | Miami | Florida | 33165 | United States |
| Pharmacosmos Investigational Site2 | Miami | Florida | 33165 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33172 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33173 | United States |
| Pharmacosmos Investigational Site1 | Miami | Florida | 33175 | United States |
| Pharmacosmos Investigational Site2 | Miami | Florida | 33175 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33176 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33183 | United States |
| Pharmacosmos Investigational Site1 | Miami | Florida | 33186 | United States |
| Pharmacosmos Investigational Site2 | Miami | Florida | 33186 | United States |
| Pharmacosmos Investigational Site | Miami Beach | Florida | 33140 | United States |
| Pharmacosmos Investigational Site | Miami Lakes | Florida | 33014 | United States |
| Pharmacosmos Investigational Site | Naples | Florida | 34102 | United States |
| Pharmacosmos Investigational Site | Ocala | Florida | 34471 | United States |
| Pharmacosmos Investigational Site | Palmetto Bay | Florida | 33157 | United States |
| Pharmacosmos Investigational Site | Pembroke Pines | Florida | 33026 | United States |
| Pharmacosmos Investigational Site | Plantation | Florida | 33322 | United States |
| Pharmacosmos Investigational Site | Port Charlotte | Florida | 33952 | United States |
| Pharmacosmos Investigational Site | St. Petersburg | Florida | 33713 | United States |
| Pharmacosmos Investigational Site1 | Tampa | Florida | 33607 | United States |
| Pharmacosmos Investigational Site2 | Tampa | Florida | 33607 | United States |
| Pharmacosmos Investigational Site | Tampa | Florida | 33614 | United States |
| Pharmacosmos Investigational Site | West Miami | Florida | 33144 | United States |
| Pharmacosmos Investigational Site | Atlanta | Georgia | 30342 | United States |
| Pharmacosmos Investigational Site | Augusta | Georgia | 30901 | United States |
| Pharmacosmos Investigational Site | Macon | Georgia | 31217 | United States |
| Pharmacosmos Investigational Site | Chicago | Illinois | 60611 | United States |
| Pharmacosmos Investigational Site | Chicago | Illinois | 60643 | United States |
| Pharmacosmos Investigational Site | Crystal Lake | Illinois | 60012 | United States |
| Pharmacosmos Investigational Site | Hinsdale | Illinois | 60521 | United States |
| Pharmacosmos Investigational Site | Fort Wayne | Indiana | 48604 | United States |
| Pharmacosmos Investigational Site | Marion | Indiana | 46952 | United States |
| Pharmacosmos Investigational Site | Merrillville | Indiana | 46410 | United States |
| Pharmacosmos Investigational Site | Michigan City | Indiana | 46360 | United States |
| Pharmacosmos Investigational Site | Kansas City | Kansas | 66160 | United States |
| Pharmacosmos Investigational Site | Wichita | Kansas | 67214 | United States |
| Pharmacosmos Investigational Site | Owensboro | Kentucky | 42301 | United States |
| Pharmacosmos Investigational Site | Baton Rouge | Louisiana | 70808 | United States |
| Pharmacosmos Investigational Site | Covington | Louisiana | 70433 | United States |
| Pharmacosmos Investigational Site | Shreveport | Louisiana | 71101 | United States |
| Pharmacosmos Investigational Site | Annapolis | Maryland | 21401 | United States |
| Pharmacosmos Investigational Site | Bethesda | Maryland | 20817 | United States |
| Pharmacosmos Investigational Site | Rockville | Maryland | 20852 | United States |
| Pharmacosmos Investigational Site | Grand Rapids | Michigan | 49525 | United States |
| Pharmacosmos Investigational Site | Florissant | Missouri | 63031 | United States |
| Pharmacosmos Investigational Site | Albuquerque | New Mexico | 87109 | United States |
| Pharmacosmos Investigational Site | Flushing | New York | 11355 | United States |
| Pharmacosmos Investigational Site | New York | New York | 10010 | United States |
| Pharmacosmos Investigational Site | New York | New York | 10016 | United States |
| Pharmacosmos Investigational Site | Asheville | North Carolina | 28801 | United States |
| Pharmacosmos Investigational Site | Gastonia | North Carolina | 28054 | United States |
| Pharmacosmos Investigational Site | Greenville | North Carolina | 27834 | United States |
| Pharmacosmos Investigational Site | Jacksonville | North Carolina | 28546 | United States |
| Pharmacosmos Investigational Site | Wilmington | North Carolina | 28401 | United States |
| Pharmacosmos Investigational Site | Cincinnati | Ohio | 45206 | United States |
| Pharmacosmos Investigational Site | Cincinnati | Ohio | 45220 | United States |
| Pharmacosmos Investigational Site | Cleveland | Ohio | 44106 | United States |
| Pharmacosmos Investigational Site | Norman | Oklahoma | 73069 | United States |
| Pharmacosmos Investigational Site | Tulsa | Oklahoma | 74136 | United States |
| Pharmacosmos Investigational Site | Bethlehem | Pennsylvania | 18107 | United States |
| Pharmacosmos Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| Pharmacosmos Investigational Site | Columbia | South Carolina | 29203 | United States |
| Pharmacosmos Investigational Site | Greenville | South Carolina | 29605 | United States |
| Pharmacosmos Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| Pharmacosmos Investigational Site | Jackson | Tennessee | 38305 | United States |
| Pharmacosmos Investigational Site | Austin | Texas | 78758 | United States |
| Pharmacosmos Investigational Site | Beaumont | Texas | 77702 | United States |
| Pharmacosmos Investigational Site | DeSoto | Texas | 75115 | United States |
| Pharmacosmos Investigational Site | El Paso | Texas | 79935 | United States |
| Pharmacosmos Investigational Site | Fort Worth | Texas | 76104 | United States |
| Pharmacosmos Investigational Site | Greenville | Texas | 75401 | United States |
| Pharmacosmos Investigational Site1 | Houston | Texas | 77030 | United States |
| Pharmacosmos Investigational Site2 | Houston | Texas | 77030 | United States |
| Pharmacosmos Investigational Site | Houston | Texas | 77084 | United States |
| Pharmacosmos Investigational Site | Houston | Texas | 77089 | United States |
| Pharmacosmos Investigational Site1 | Houston | Texas | 77099 | United States |
| Pharmacosmos Investigational Site2 | Houston | Texas | 77099 | United States |
| Pharmacosmos Investigational Site | Lufkin | Texas | 75904 | United States |
| Pharmacosmos Investigational Site | McKinney | Texas | 75069 | United States |
| Pharmacosmos Investigational Site | Pearland | Texas | 77581 | United States |
| Pharmacosmos Investigational Site1 | San Antonio | Texas | 78215 | United States |
| Pharmacosmos Investigational Site2 | San Antonio | Texas | 78215 | United States |
| Pharmacosmos Investigational Site | St. George | Utah | 84790 | United States |
| Pharmacosmos Investigational Site | Arlington | Virginia | 22207 | United States |
| Pharmacosmos Investigational Site | Fairfax | Virginia | 22033 | United States |
| Iron Sucrose |
Iron sucrose (Venofer®) was the comparator in this trial. Subjects received iron sucrose (Venofer®), 200 mg IV injection up to a maximum of 5 IV injections within the first 2 weeks, starting at baseline (a cumulative dose of 1000 mg was recommended). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Iron Isomaltoside/Ferric Derisomaltose | Iron isomaltoside/ferric derisomaltose, administered IV |
| BG001 | Iron Sucrose | Iron sucrose, administered IV |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Current smoker | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Intention to treat (ITT). All randomised subjects. | Posted | Least Squares Mean | 95% Confidence Interval | g/dL | Baseline to week 8 |
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| 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. | Safety analysis set. All randomised subjects who received at least one dose of the investigational product. | Posted | Count of Participants | Participants | Baseline to week 8 |
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| 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:
Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs. | Safety analysis set. All randomised subjects who received at least one dose of the investigational product. | Posted | Count of Participants | Participants | Baseline, week 1, 2, and 8 |
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| 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. | Safety analysis set. All randomised subjects who received at least one dose of the investigational product. | Posted | Median | 95% Confidence Interval | Week | Baseline, week 1, 2, 4, and 8 |
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| 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. | Safety analysis set. All randomised subjects who received at least one dose of the investigational product. | Posted | Count of Participants | Participants | Baseline, week 1, 2, 4, and 8 |
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| 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). | ITT. All randomised subjects. | Posted | Count of Participants | Participants | Baseline, week 1, 2, 4, and 8 |
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| 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. | ITT. All randomised subjects. | Posted | Median | 95% Confidence Interval | Days | Baseline, week 1, 2, 4, and 8 |
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| 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. | ITT. All randomised subjects. | Posted | Count of Participants | Participants | Week 1 to week 8 |
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| 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. | ITT. All randomised subjects. | Posted | Count of Participants | Participants | Week 1 to week 8 |
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| 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. | ITT. All randomised subjects. | Posted | Count of Participants | Participants | Week 1 to week 8 |
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| 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. | ITT. All randomised subjects. | Posted | Mean | Standard Deviation | g/dL | Baseline, week 1, 2, and 4 |
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| 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. | ITT. All randomised subjects. | Posted | Mean | Standard Deviation | ng/mL | Baseline, week 1, 2, 4, and 8 |
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| 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. | ITT. All randomised subjects. | Posted | Mean | Standard Deviation | percent | Baseline, week 1, 2, 4, and 8 |
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| 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. | ITT. All randomised subjects. | Posted | Mean | Standard Deviation | μg/dL | Baseline, week 1, 2, 4, and 8 |
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| 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 | ITT. All randomised subjects. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 1, 2, and 8 |
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| 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). | ITT. All randomised subjects. | Posted | Median | Full Range | US dollars ($) | Baseline |
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| 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). | ITT. All randomised subjects. The number of participants analyzed were less the number of participants starting the study since not all participants had data collected for this outcome measure. | Posted | Median | Full Range | miles | Baseline |
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| 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). | ITT. All randomised subjects. | Posted | Median | Full Range | Hours | Baseline |
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| 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). | ITT. All randomised subjects. | Posted | Count of Participants | Participants | Baseline |
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| 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). | ITT. All randomised subjects. | Posted | Median | Full Range | hours | Baseline |
|
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).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iron Isomaltoside/Ferric Derisomaltose | Iron isomaltoside/ferric derisomaltose, administered IV | 3 | 1,019 | 83 | 1,019 | 56 | 1,019 |
| EG001 | Iron Sucrose | Iron sucrose, administered IV | 3 | 506 | 50 | 506 | 34 | 506 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urethral obstruction | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gas gangrene | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haemorrhagic arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
Institution may publish the study results. Before submission for publication or presentation, Institution shall allow Sponsor not less than 90 days to review any manuscript and not less than 30 days to review any poster presentation, abstract, or any other written or oral material which describes or discloses the study results. If sponsor so requests in writing, Institution shall withhold any publication or presentation for an additional 90 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical trial disclosure desk | Pharmacosmos A/S | +45 5948 5935 | trial@pharmacosmos.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2018 | Jan 6, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
| C000718030 | ferric derisomaltose |
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
Not provided
Not provided
| 65-84 years |
|
| > 84 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Indigenous Mexican |
|
| Mixed (Caucasian and Native american) |
|
| Hispanic |
|
| Central Indian |
|
| Guyanese |
|
| Other (Mixed: not declared) |
|
| NO |
|
| Non-Inferiority |
Non-inferiority could be claimed if the lower bound of the 95% confidence interval (CI) was above -0.5 g/dL. |
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