Trial · NCT02940860
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| 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. |
| Secondary | Change in Hb Concentration From Baseline to Week 1, 2, and 4 | Baseline, week 1, 2, and 4 | Efficacy Change in Hb concentration from baseline to week 1, 2, and 4. |
| Secondary | Change in S-ferritin From Baseline to Weeks 1, 2, 4, and 8 | Baseline, week 1, 2, 4, and 8 | Efficacy Changes in s-ferritin from baseline to weeks 1, 2, 4, and 8. |
| Secondary | Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8 | Baseline, week 1, 2, 4, and 8 | Efficacy Changes in transferrin saturation (TSAT) from baseline to week 1, 2, 4, and 8. |
| Secondary | Change in Concentration of S-iron From Baseline to Week 1, 2, 4, and 8 | Baseline, week 1, 2, 4, and 8 | Efficacy Changes in the concentrations of serum iron (s-iron) from baseline to week 1, 2, 4, and 8. |
| Secondary | Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8 | Baseline, week 1, 2, and 8 | Efficacy Change in fatigue symptoms from baseline to week 1, 2, and 8 was measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale consisted of 13 items ranging from 0 (not at all) to 4 (very much), except items #7 and #8 which are reversed scored. The total score range is 0-52. A score of less than 30 indicated severe fatigue, and the higher the score, the better outcome/quality of life (QoL). If more than 50% of the items for a subject at a given visit were missing, the total score was not calculated. Total score was calculated as shown below: Total score= Sum of individual scores x 13 / Number of items answered |
| Secondary | Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking | Baseline | Pharmacoeconomics The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group). |
| Secondary | Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car | Baseline | Pharmacoeconomics The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group). |
| Secondary | Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit | Baseline | Pharmacoeconomics The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group). |
| Secondary | Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits | Baseline | Pharmacoeconomics The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group). |
| Secondary | Health Care Resource Use Questionnaire | Baseline | Pharmacoeconomics Resources used by the health care staff (per administration), measured by the health care resource use questionnaire. The questionnaire assessed the time used by the health care staff during administration of the investigational product and the administration time (including the observational time). The health care participants included in the evaluation were: investigator, pharmacist, physician, study coordinator, study nurse. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the 2 treatment groups is different (i.e. up to a factor 5 more frequent in the iron sucrose treatment group). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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