Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.
Among the various formulations of parenteral iron that are currently available, iron isomaltoside/ferric derisomaltose may allow flexibility in terms of high and rapid dosing. Up to now, most clinical trials with intravenous (IV) iron treatment were of 4-12 weeks in duration; longer trials are warranted to follow-up on long-term safety.
The aim of the trial was to evaluate the safety and efficacy of IV iron isomaltoside/ferric derisomaltose re-dosing in subjects who were previously treated with iron isomaltoside/ferric derisomaltose in lead-in trials.
This was a 6-months extension trial lasting 26 weeks. Eligible subjects attended 5 visits: screening, baseline (subjects treated with a single IV dose of 1000 mg iron isomaltoside/ferric derisomaltose), and follow-up visits at week 2, 13, and 26 weeks after the IV dose, for safety and efficacy assessments.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron isomaltoside/ferric derisomaltose | Experimental | 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 from the site's supply and administered over approximately 20 minutes using IV infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Drug Reactions (ADR) | Safety Evaluate the number of subjects with adverse drug reactions (ADRs), defined as AEs that were assessed by the investigator as related or possible related to the investigational product. | Baseline to week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 terms that were included in the analysis were those that started or after the first dose of 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Chula Vista | California | 91910 | United States | ||
| Pharmacosmos Investigational Site 1 |
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects enrolled in this extension trial had previously participated in the lead-in trials IDA-03 (52%, NCT02940886), CKD-04 (32%, NCT02940860), and IDA-01 (16%, NCT02130063).
A total of 193 subjects were screened and 103 subjects were enrolled into the trial.
Not provided
| 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 7, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Baseline to week 26 |
| Composite Cardiovascular Adverse Events (AEs) | Safety Results show the composite cardiovascular AEs, that started on or after the first dose of treatment (i.e. treatment emergent) up to month 6. 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. | Baseline to week 26 |
| 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 Clinical Endpoint Adjudication Committee (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 2, 13, and 26 |
| S-phosphate <2 mg/dL at Any Time From Baseline to Week 26 | Safety Results show the number of trial participants and their status of s-phosphate <2 mg/dL, at any time from baseline to week 26. | Baseline to week 26 |
| Change in Hb From Baseline to Week 2, 13, and 26 | Efficacy. Change in Hb from baseline to week 2, 13, and 26. | Baseline, week 2, 13, and 26 |
| Change in S-ferritin From Baseline to Week 2, 13, and 26 | Efficacy. Change in s-ferritin from baseline to week 2, 13, and 26. | Baseline, week 2, 13, and 26 |
| Change in Transferrin Saturation (TSAT) From Baseline to Week 2, 13, and 26 | Efficacy Change in transferrin saturation (TSAT) from baseline to week 2, 13, and 26. TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron. | Baseline, week 2, 13, and 26 |
| Change in S-iron From Baseline to Week 2, 13, and 26 | Efficacy. Change in s-iron from baseline to week 2, 13, and 26. | Baseline, week 2, 13, and 26 |
| La Mesa |
| California |
| 91942 |
| United States |
| Pharmacosmos Investigational Site 2 | La Mesa | California | 91942 | United States |
| Pharmacosmos Investigational Site | Northridge | California | 91324 | United States |
| Pharmacosmos Investigational Site | Porterville | California | 93257 | United States |
| Pharmacosmos Investigational Site | Doral | Florida | 33172 | United States |
| Pharmacosmos Investigational Site | Hialeah | Florida | 33012 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33135 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33147 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33165 | United States |
| Pharmacosmos Investigational Site | Miami Lakes | Florida | 33014 | United States |
| Pharmacosmos Investigational Site | West Palm Beach | Florida | 33409 | United States |
| Pharmacosmos Investigational Site | Baton Rouge | Louisiana | 70808 | United States |
| Pharmacosmos Investigational Site | Metairie | Louisiana | 70006 | United States |
| Pharmacosmos Investigational Site | New Orleans | Louisiana | 70125 | United States |
| Pharmacosmos Investigational Site | Shreveport | Louisiana | 71101 | United States |
| Pharmacosmos Investigational Site | Plainsboro | New Jersey | 08536 | United States |
| Pharmacosmos Investigational Site | Albuquerque | New Mexico | 87109 | United States |
| Pharmacosmos Investigational Site | Chattanooga | Tennessee | 37404 | United States |
| Pharmacosmos Investigational Site | Houston | Texas | 77030 | United States |
| Pharmacosmos Investigational Site 1 | San Antonio | Texas | 78215 | United States |
| Pharmacosmos Investigational Site 2 | San Antonio | Texas | 78215 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Iron Isomaltoside/Ferric Derisomaltose | Iron isomaltoside/ferric derisomaltose, administered IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Current smoker | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Adverse Drug Reactions (ADR) | Safety Evaluate the number of subjects with adverse drug reactions (ADRs), defined as AEs that were assessed by the investigator as related or possible related to the investigational product. | Safety analysis set: included all subjects who received at least one dose of the investigational product. | Posted | Count of Participants | Participants | Baseline to week 26 |
|
|
| ||||||||||||||||||||||||||
| Secondary | 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 terms that were included in the analysis were those that started or after the first dose of 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: included all subjects who received at least one dose of the investigational product. | Posted | Count of Participants | Participants | Baseline to week 26 |
|
| |||||||||||||||||||||||||||
| Secondary | Composite Cardiovascular Adverse Events (AEs) | Safety Results show the composite cardiovascular AEs, that started on or after the first dose of treatment (i.e. treatment emergent) up to month 6. 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: included all subjects who received at least one dose of the investigational product. | Posted | Count of Participants | Participants | Baseline to week 26 |
|
| |||||||||||||||||||||||||||
| 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 Clinical Endpoint Adjudication Committee (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: included all subjects who received at least one dose of the investigational product. | Posted | Median | 95% Confidence Interval | week | Baseline, week 2, 13, and 26 |
|
| ||||||||||||||||||||||||||
| Secondary | S-phosphate <2 mg/dL at Any Time From Baseline to Week 26 | Safety Results show the number of trial participants and their status of s-phosphate <2 mg/dL, at any time from baseline to week 26. | Safety analysis set: included all subjects who received at least one dose of the investigational product. | Posted | Count of Participants | Participants | Baseline to week 26 |
|
| |||||||||||||||||||||||||||
| Secondary | Change in Hb From Baseline to Week 2, 13, and 26 | Efficacy. Change in Hb from baseline to week 2, 13, and 26. | Intention-to-treat (ITT) analysis set: included all subjects, except for screening failures and subjects withdrawn before visit 2 (baseline). | Posted | Mean | Standard Deviation | g/dL | Baseline, week 2, 13, and 26 |
|
| ||||||||||||||||||||||||||
| Secondary | Change in S-ferritin From Baseline to Week 2, 13, and 26 | Efficacy. Change in s-ferritin from baseline to week 2, 13, and 26. | Intention-to-treat (ITT) analysis set: included all subjects, except for screening failures and subjects withdrawn before visit 2 (baseline). | Posted | Mean | Standard Deviation | ng/mL | Baseline, week 2, 13, and 26 |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Transferrin Saturation (TSAT) From Baseline to Week 2, 13, and 26 | Efficacy Change in transferrin saturation (TSAT) from baseline to week 2, 13, and 26. TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron. | Intention-to-treat (ITT) analysis set: included all subjects, except for screening failures and subjects withdrawn before visit 2 (baseline). | Posted | Mean | Standard Deviation | percentage of saturation | Baseline, week 2, 13, and 26 |
|
| ||||||||||||||||||||||||||
| Secondary | Change in S-iron From Baseline to Week 2, 13, and 26 | Efficacy. Change in s-iron from baseline to week 2, 13, and 26. | Intention-to-treat (ITT) analysis set: included all subjects, except for screening failures and subjects withdrawn before visit 2 (baseline). | Posted | Mean | Standard Deviation | μg/dL | Baseline, week 2, 13, and 26 |
|
|
From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (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 | 1 | 193 | 13 | 102 | 17 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Endometritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system 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 | Jul 18, 2018 | Jan 7, 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 |
Not provided
Not provided
Not provided
| >84 years |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
| Title | Denominators | Categories | ||||||
|---|---|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 2 |
|
| ||||
| Week 13 |
|
| ||||
| Week 26 |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 2 |
|
| ||||
| Week 13 |
|
| ||||
| Week 26 |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 2 |
|
| ||||
| Week 13 |
|
| ||||
| Week 26 |
|
|