Trial · NCT02940860
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease
NCT02940860, Phase 3, Completed, Pharmacosmos A/S; results first posted 2020-03-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease. Trials, record NCT02940860. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02940860
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease
- NCT number
- NCT02940860
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,538 participants, actual
- Lead sponsor
- Pharmacosmos A/S
- Conditions
- Iron Deficiency Anaemia, Iron Deficiency Anemia, Chronic Kidney Disease
- Interventions
- Iron isomaltoside/ferric derisomaltose, Iron sucrose
- First posted
- 2016-10-21
- Last updated
- 2020-10-06
- Results first posted
- 2020-03-06
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Hemoglobin (Hb) From Baseline to Week 8 | 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. |
| Primary | Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions | 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. |
| Secondary | Composite Cardiovascular Adverse Events (AEs) | 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. |
| Secondary | Time to First Composite Cardiovascular Safety AE | 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. |
| Secondary | S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8 | 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. |
| Secondary | Hb Concentration Increase of ≥1 g/dL From Baseline to Week 1, 2, 4, and 8 | 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). |
| Secondary | Time to Change in Hb Concentration ≥1 g/dL | 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. |
| Secondary | Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8 | 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. |
| Secondary | Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8 | 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. |
| Secondary | S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8 | 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Hemoglobin (Hb) From Baseline to Week 8 | Baseline to week 8 | Intention to treat (ITT). All randomised subjects. | g/dL | LEAST_SQUARES_MEAN |
| PRIMARY | Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions | Baseline to week 8 | Safety analysis set. All randomised subjects who received at least one dose of the investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Composite Cardiovascular Adverse Events (AEs) | Baseline, week 1, 2, and 8 | Safety analysis set. All randomised subjects who received at least one dose of the investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Composite Cardiovascular Safety AE | Baseline, week 1, 2, 4, and 8 | Safety analysis set. All randomised subjects who received at least one dose of the investigational product. | Week | MEDIAN |
| SECONDARY | S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8 | Baseline, week 1, 2, 4, and 8 | Safety analysis set. All randomised subjects who received at least one dose of the investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hb Concentration Increase of ≥1 g/dL From Baseline to Week 1, 2, 4, and 8 | Baseline, week 1, 2, 4, and 8 | ITT. All randomised subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Change in Hb Concentration ≥1 g/dL | Baseline, week 1, 2, 4, and 8 | ITT. All randomised subjects. | Days | MEDIAN |
| SECONDARY | Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8 | Week 1 to week 8 | ITT. All randomised subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8 | Week 1 to week 8 | ITT. All randomised subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8 | Week 1 to week 8 | ITT. All randomised subjects. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Hemoglobin (Hb) From Baseline to Week 8 | Iron Isomaltoside/Ferric Derisomaltose | 1.22 | 95% Confidence Interval 1.14 to 1.31 | g/dL | |
| Change in Hemoglobin (Hb) From Baseline to Week 8 | Iron Sucrose | 1.14 | 95% Confidence Interval 1.03 to 1.26 | g/dL | |
| Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions | Iron Isomaltoside/Ferric Derisomaltose | 3 | Participants | ||
| Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions | Iron Sucrose | 0 | Participants | ||
| Composite Cardiovascular Adverse Events (AEs) | Iron Isomaltoside/Ferric Derisomaltose | 42 | Participants | ||
| Composite Cardiovascular Adverse Events (AEs) | Iron Sucrose | 35 | Participants | ||
| Time to First Composite Cardiovascular Safety AE | Iron Isomaltoside/Ferric Derisomaltose | NA | 95% Confidence Interval NA to NA | Week | |
| Time to First Composite Cardiovascular Safety AE | Iron Sucrose | NA | 95% Confidence Interval NA to NA | Week | |
| S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8 | Iron Isomaltoside/Ferric Derisomaltose | 32 | Participants | ||
| S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8 | Iron Sucrose | 4 | Participants |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Iron Isomaltoside/Ferric Derisomaltose | 1,027 | |
| Overall Study | STARTED | Iron Sucrose | 511 | |
| Overall Study | COMPLETED | Iron Isomaltoside/Ferric Derisomaltose | 971 | |
| Overall Study | COMPLETED | Iron Sucrose | 476 | |
| Overall Study | NOT COMPLETED | Iron Isomaltoside/Ferric Derisomaltose | 56 | |
| Overall Study | NOT COMPLETED | Iron Sucrose | 35 |
Source ClinicalTrials.gov
Adverse events194
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Urinary tract infection | Infections and infestations | Iron Isomaltoside/Ferric Derisomaltose | 22 | 1,019 | 22 |
| other | Urinary tract infection | Infections and infestations | Iron Sucrose | 14 | 506 | 14 |
| other | Hypertension | Vascular disorders | Iron Isomaltoside/Ferric Derisomaltose | 14 | 1,019 | 15 |
| other | Hypertension | Vascular disorders | Iron Sucrose | 13 | 506 | 18 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Iron Isomaltoside/Ferric Derisomaltose | 22 | 1,019 | 22 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Iron Sucrose | 9 | 506 | 10 |
| serious | Cardiac failure congestive | Cardiac disorders | Iron Isomaltoside/Ferric Derisomaltose | 7 | 1,019 | 7 |
| serious | Cardiac failure congestive | Cardiac disorders | Iron Sucrose | 11 | 506 | 13 |
| serious | Atrial fibrillation | Cardiac disorders | Iron Isomaltoside/Ferric Derisomaltose | 1 | 1,019 | 1 |
| serious | Atrial fibrillation | Cardiac disorders | Iron Sucrose | 2 | 506 | 2 |
1 to 10 of 194Source ClinicalTrials.gov
See all 194 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Iron Isomaltoside/Ferric Derisomaltose | 3 | 1,019 |
| Total, all-cause mortality | Iron Sucrose | 3 | 506 |
| Total, other adverse events | Iron Isomaltoside/Ferric Derisomaltose | 56 | 1,019 |
| Total, other adverse events | Iron Sucrose | 34 | 506 |
| Total, serious adverse events | Iron Isomaltoside/Ferric Derisomaltose | 83 | 1,019 |
| Total, serious adverse events | Iron Sucrose | 50 | 506 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32049331 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose: Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions | Trial comparisons |
| Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose: Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8 | Trial comparisons |
| Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose: S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8 | Trial comparisons |
| Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose: Composite Cardiovascular Adverse Events (AEs) | Trial comparisons |
| Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose: S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8 | Trial comparisons |
| Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose: deaths from any cause | Trial comparisons |
| Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose: Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8 | Trial comparisons |
| Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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