Trial · NCT03457701
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO | Up to Day 57 | Blood samples were collected at indicated time points for analysis of fractional oral iron absorption following treatment with Daprodustat and rhEPO. Adjusted mean and 95 percent (%) confidence interval (CI) has been presented. |
| Secondary | Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected for measurement of serum iron at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Period 1 and 2: Change From Baseline in Transferrin Following Treatment With Daprodustat or rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of transferrin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Periods 1 and 2: Change From Baseline in Transferrin Saturation Following Treatment With Daprodustat or rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of transferrin saturation at indicated time points. Transferrin saturation was measured as a percentage and is the ratio of serum iron and total iron-binding capacity multiplied by 100. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Periods 1 and 2: Change From Baseline in Soluble Transferrin Receptor Following Treatment of Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of soluble transferrin receptor at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Periods 1 and 2: Ratio to Baseline in Ferritin Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of ferritin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The summary of log transformed ration to baseline on markers of iron status for Ferritin is presented here. |
| Secondary | Periods 1 and 2: Ratio to Baseline (Day 1) in Hepcidin Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of hepcidin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The summary of log transformed ration to baseline on markers of iron status for Hepcidin is presented here. |
| Secondary | Periods 1 and 2: Change From Baseline in Erythroferrone Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of erythroferrone at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Periods 1 and 2: Change From Baseline in Hemoglobin Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of hemoglobin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Periods 1 and 2: Change From Baseline in Hematocrit Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of hematocrit at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Periods 1 and 2: Change From Baseline in Erythrocytes Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of erythrocytes (red blood cells number) at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Periods 1 and 2: Change From Baseline in Erythrocyte Mean Corpuscular Volume Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of erythrocyte mean corpuscular volume at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Periods 1 and 2: Change From Baseline in Reticulocyte Hemoglobin Following Treatment of Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of reticulocyte hemoglobin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Periods 1 and 2: Change From Baseline in Reticulocytes Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of reticulocytes number at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
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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