Trial Outcomes & Findings for Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe) (NCT NCT03457701)
NCT ID: NCT03457701
Last Updated: 2024-03-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Up to Day 57
Results posted on
2024-03-27
Participant Flow
This was a two-period cross over study to compare the effect of Daprodustat to recombinant, human erythropoietin (rhEPO) on oral iron absorption.
A total of 15 participants were randomized in the study. The safety population consisted of 14 participants who received at least 1 dose of study treatment.
Participant milestones
| Measure |
Daprodustat Followed by rhEPO
Participants were randomly assigned to receive Daprodustat in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. At Day 29 participants were crossed over to receive rhEPO (either epoetin alfa or darbepoetin alfa) in Treatment Period 2. At 2 weeks following initiation of dosing in Treatment Period 2, participants were again administered ferrous sulfate containing the stable iron isotope (58Fe or 57Fe). Participants were advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: H2 receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency. There was no washout period between Treatment Period 1 and Treatment Period 2.
|
rhEPO Followed by Daprodustat
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. At Day 29 participants were crossed over to receive Daprodustat in Treatment Period 2. At 2 weeks following initiation of dosing in Treatment Period 2, participants were again administered ferrous sulfate containing the stable iron isotope (58Fe or 57Fe). Participants were advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: Histamine \[H2\] receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency. There was no washout period between Treatment Period 1 and Treatment Period 2.
|
|---|---|---|
|
Treatment Period 1 (up to Day 28)
STARTED
|
7
|
8
|
|
Treatment Period 1 (up to Day 28)
Safety Population
|
7
|
7
|
|
Treatment Period 1 (up to Day 28)
COMPLETED
|
6
|
7
|
|
Treatment Period 1 (up to Day 28)
NOT COMPLETED
|
1
|
1
|
|
Treatment Period 2 (Up to Day 28)
STARTED
|
6
|
7
|
|
Treatment Period 2 (Up to Day 28)
COMPLETED
|
6
|
6
|
|
Treatment Period 2 (Up to Day 28)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Daprodustat Followed by rhEPO
Participants were randomly assigned to receive Daprodustat in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. At Day 29 participants were crossed over to receive rhEPO (either epoetin alfa or darbepoetin alfa) in Treatment Period 2. At 2 weeks following initiation of dosing in Treatment Period 2, participants were again administered ferrous sulfate containing the stable iron isotope (58Fe or 57Fe). Participants were advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: H2 receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency. There was no washout period between Treatment Period 1 and Treatment Period 2.
|
rhEPO Followed by Daprodustat
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. At Day 29 participants were crossed over to receive Daprodustat in Treatment Period 2. At 2 weeks following initiation of dosing in Treatment Period 2, participants were again administered ferrous sulfate containing the stable iron isotope (58Fe or 57Fe). Participants were advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: Histamine \[H2\] receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency. There was no washout period between Treatment Period 1 and Treatment Period 2.
|
|---|---|---|
|
Treatment Period 1 (up to Day 28)
Participant reached protocol-defined stopping criteria
|
1
|
1
|
|
Treatment Period 2 (Up to Day 28)
Participant reached protocol-defined stopping criteria
|
0
|
1
|
Baseline Characteristics
Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)
Baseline characteristics by cohort
| Measure |
Daprodustat Followed by rhEPO
n=7 Participants
Participants were randomly assigned to receive Daprodustat in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. At Day 29 participants were crossed over to receive rhEPO (either epoetin alfa or darbepoetin alfa) in Treatment Period 2. At 2 weeks following initiation of dosing in Treatment Period 2, participants were again administered ferrous sulfate containing the stable iron isotope (58Fe or 57Fe). Participants were advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: H2 receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency. There was no washout period between Treatment Period 1 and Treatment Period 2.
|
rhEPO Followed by Daprodustat
n=7 Participants
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. At Day 29 participants were crossed over to receive Daprodustat in Treatment Period 2. At 2 weeks following initiation of dosing in Treatment Period 2, participants were again administered ferrous sulfate containing the stable iron isotope (58Fe or 57Fe). Participants were advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: Histamine \[H2\] receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency. There was no washout period between Treatment Period 1 and Treatment Period 2.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.3 Years
STANDARD_DEVIATION 5.35 • n=5 Participants
|
64.6 Years
STANDARD_DEVIATION 13.88 • n=7 Participants
|
65.4 Years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian/European Heritage
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 57Population: Evaluable Population consisted of all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods.
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.
Outcome measures
| Measure |
Daprodustat
n=12 Participants
Participants were randomly assigned to receive Daprodustat in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
rhEPO
n=12 Participants
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
|---|---|---|
|
Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO
|
20.64 Percentage (%) of iron absorbed
Interval 10.96 to 30.32
|
20.62 Percentage (%) of iron absorbed
Interval 10.95 to 30.3
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)Population: Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Daprodustat
n=12 Participants
Participants were randomly assigned to receive Daprodustat in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
rhEPO
n=12 Participants
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
|---|---|---|
|
Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO
Period 1, DAY 14
|
-1.5 Micromoles per liter (umol/L)
Standard Deviation 6.72
|
1.7 Micromoles per liter (umol/L)
Standard Deviation 4.93
|
|
Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO
Period 1, DAY 28
|
2.5 Micromoles per liter (umol/L)
Standard Deviation 8.96
|
3.3 Micromoles per liter (umol/L)
Standard Deviation 5.47
|
|
Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO
Period 2, DAY 14
|
-1.3 Micromoles per liter (umol/L)
Standard Deviation 4.93
|
-3.5 Micromoles per liter (umol/L)
Standard Deviation 6.66
|
|
Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO
Period 2, DAY 28
|
-2.2 Micromoles per liter (umol/L)
Standard Deviation 4.79
|
-3.3 Micromoles per liter (umol/L)
Standard Deviation 5.01
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)Population: Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Daprodustat
n=12 Participants
Participants were randomly assigned to receive Daprodustat in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
rhEPO
n=12 Participants
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
|---|---|---|
|
Period 1 and 2: Change From Baseline in Transferrin Following Treatment With Daprodustat or rhEPO
Period 1, DAY 14
|
0.182 Gram per Liter (g/L)
Standard Deviation 0.2914
|
0.145 Gram per Liter (g/L)
Standard Deviation 0.2501
|
|
Period 1 and 2: Change From Baseline in Transferrin Following Treatment With Daprodustat or rhEPO
Period 1, DAY 28
|
0.283 Gram per Liter (g/L)
Standard Deviation 0.2824
|
-0.040 Gram per Liter (g/L)
Standard Deviation 0.1756
|
|
Period 1 and 2: Change From Baseline in Transferrin Following Treatment With Daprodustat or rhEPO
Period 2, DAY 14
|
-0.177 Gram per Liter (g/L)
Standard Deviation 0.4664
|
-0.163 Gram per Liter (g/L)
Standard Deviation 0.2461
|
|
Period 1 and 2: Change From Baseline in Transferrin Following Treatment With Daprodustat or rhEPO
Period 2, DAY 28
|
0.138 Gram per Liter (g/L)
Standard Deviation 0.2381
|
-0.352 Gram per Liter (g/L)
Standard Deviation 0.2531
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)Population: Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Daprodustat
n=12 Participants
Participants were randomly assigned to receive Daprodustat in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
rhEPO
n=12 Participants
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
|---|---|---|
|
Periods 1 and 2: Change From Baseline in Transferrin Saturation Following Treatment With Daprodustat or rhEPO
Period 1, DAY 14
|
-5.2 Percentage (%) of transferrin saturation
Standard Deviation 13.63
|
3.5 Percentage (%) of transferrin saturation
Standard Deviation 12.05
|
|
Periods 1 and 2: Change From Baseline in Transferrin Saturation Following Treatment With Daprodustat or rhEPO
Period 1, DAY 28
|
3.0 Percentage (%) of transferrin saturation
Standard Deviation 18.13
|
8.2 Percentage (%) of transferrin saturation
Standard Deviation 14.41
|
|
Periods 1 and 2: Change From Baseline in Transferrin Saturation Following Treatment With Daprodustat or rhEPO
Period 2, DAY 14
|
-5.5 Percentage (%) of transferrin saturation
Standard Deviation 13.40
|
-4.8 Percentage (%) of transferrin saturation
Standard Deviation 10.98
|
|
Periods 1 and 2: Change From Baseline in Transferrin Saturation Following Treatment With Daprodustat or rhEPO
Period 2, DAY 28
|
-6.7 Percentage (%) of transferrin saturation
Standard Deviation 14.57
|
-4.7 Percentage (%) of transferrin saturation
Standard Deviation 11.29
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)Population: Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Daprodustat
n=12 Participants
Participants were randomly assigned to receive Daprodustat in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
rhEPO
n=12 Participants
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
|---|---|---|
|
Periods 1 and 2: Change From Baseline in Soluble Transferrin Receptor Following Treatment of Daprodustat and rhEPO
Period 1, DAY 14
|
-0.218 Milligrams per liter (mg/L)
Standard Deviation 0.1736
|
0.063 Milligrams per liter (mg/L)
Standard Deviation 0.1669
|
|
Periods 1 and 2: Change From Baseline in Soluble Transferrin Receptor Following Treatment of Daprodustat and rhEPO
Period 1, DAY 28
|
-0.340 Milligrams per liter (mg/L)
Standard Deviation 0.2665
|
-0.015 Milligrams per liter (mg/L)
Standard Deviation 0.1598
|
|
Periods 1 and 2: Change From Baseline in Soluble Transferrin Receptor Following Treatment of Daprodustat and rhEPO
Period 2, DAY 14
|
-0.338 Milligrams per liter (mg/L)
Standard Deviation 0.2978
|
0.227 Milligrams per liter (mg/L)
Standard Deviation 0.1086
|
|
Periods 1 and 2: Change From Baseline in Soluble Transferrin Receptor Following Treatment of Daprodustat and rhEPO
Period 2, DAY 28
|
-0.308 Milligrams per liter (mg/L)
Standard Deviation 0.3180
|
0.195 Milligrams per liter (mg/L)
Standard Deviation 0.2239
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)Population: Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Daprodustat
n=12 Participants
Participants were randomly assigned to receive Daprodustat in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
rhEPO
n=12 Participants
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
|---|---|---|
|
Periods 1 and 2: Ratio to Baseline in Ferritin Following Treatment With Daprodustat and rhEPO
Period 1, DAY 14
|
1.126 Microgram per liter (ug/L)
Geometric Coefficient of Variation 20.1853
|
0.937 Microgram per liter (ug/L)
Geometric Coefficient of Variation 16.2891
|
|
Periods 1 and 2: Ratio to Baseline in Ferritin Following Treatment With Daprodustat and rhEPO
Period 1, DAY 28
|
1.109 Microgram per liter (ug/L)
Geometric Coefficient of Variation 24.7052
|
1.004 Microgram per liter (ug/L)
Geometric Coefficient of Variation 5.4818
|
|
Periods 1 and 2: Ratio to Baseline in Ferritin Following Treatment With Daprodustat and rhEPO
Period 2, DAY 14
|
1.067 Microgram per liter (ug/L)
Geometric Coefficient of Variation 32.7697
|
0.957 Microgram per liter (ug/L)
Geometric Coefficient of Variation 20.2623
|
|
Periods 1 and 2: Ratio to Baseline in Ferritin Following Treatment With Daprodustat and rhEPO
Period 2, DAY 28
|
1.278 Microgram per liter (ug/L)
Geometric Coefficient of Variation 53.1128
|
0.911 Microgram per liter (ug/L)
Geometric Coefficient of Variation 23.5414
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)Population: Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Daprodustat
n=12 Participants
Participants were randomly assigned to receive Daprodustat in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
rhEPO
n=12 Participants
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
|---|---|---|
|
Periods 1 and 2: Ratio to Baseline (Day 1) in Hepcidin Following Treatment With Daprodustat and rhEPO
Period 1, DAY 14
|
0.860 Microgram per liter (ug/L)
Geometric Coefficient of Variation 86.4844
|
0.904 Microgram per liter (ug/L)
Geometric Coefficient of Variation 52.1384
|
|
Periods 1 and 2: Ratio to Baseline (Day 1) in Hepcidin Following Treatment With Daprodustat and rhEPO
Period 1, DAY 28
|
0.916 Microgram per liter (ug/L)
Geometric Coefficient of Variation 61.2898
|
1.052 Microgram per liter (ug/L)
Geometric Coefficient of Variation 27.7868
|
|
Periods 1 and 2: Ratio to Baseline (Day 1) in Hepcidin Following Treatment With Daprodustat and rhEPO
Period 2, DAY 14
|
0.703 Microgram per liter (ug/L)
Geometric Coefficient of Variation 74.4694
|
1.201 Microgram per liter (ug/L)
Geometric Coefficient of Variation 63.6067
|
|
Periods 1 and 2: Ratio to Baseline (Day 1) in Hepcidin Following Treatment With Daprodustat and rhEPO
Period 2, DAY 28
|
0.802 Microgram per liter (ug/L)
Geometric Coefficient of Variation 73.5598
|
1.306 Microgram per liter (ug/L)
Geometric Coefficient of Variation 47.6931
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)Population: Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Daprodustat
n=12 Participants
Participants were randomly assigned to receive Daprodustat in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
rhEPO
n=12 Participants
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
|---|---|---|
|
Periods 1 and 2: Change From Baseline in Erythroferrone Following Treatment With Daprodustat and rhEPO
Period 1, DAY 14
|
0.135 Microgram per liter (ug/L)
Standard Deviation 0.3086
|
-0.062 Microgram per liter (ug/L)
Standard Deviation 0.1824
|
|
Periods 1 and 2: Change From Baseline in Erythroferrone Following Treatment With Daprodustat and rhEPO
Period 1, DAY 28
|
0.075 Microgram per liter (ug/L)
Standard Deviation 0.2544
|
-0.090 Microgram per liter (ug/L)
Standard Deviation 0.1380
|
|
Periods 1 and 2: Change From Baseline in Erythroferrone Following Treatment With Daprodustat and rhEPO
Period 2, DAY 14
|
0.063 Microgram per liter (ug/L)
Standard Deviation 0.2225
|
-0.068 Microgram per liter (ug/L)
Standard Deviation 0.2405
|
|
Periods 1 and 2: Change From Baseline in Erythroferrone Following Treatment With Daprodustat and rhEPO
Period 2, DAY 28
|
0.032 Microgram per liter (ug/L)
Standard Deviation 0.3578
|
-0.110 Microgram per liter (ug/L)
Standard Deviation 0.2278
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)Population: Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Daprodustat
n=12 Participants
Participants were randomly assigned to receive Daprodustat in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
rhEPO
n=12 Participants
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
|---|---|---|
|
Periods 1 and 2: Change From Baseline in Hemoglobin Following Treatment With Daprodustat and rhEPO
Period 1, DAY 14
|
0.7 Grams per liter (g/L)
Standard Deviation 3.67
|
2.8 Grams per liter (g/L)
Standard Deviation 2.99
|
|
Periods 1 and 2: Change From Baseline in Hemoglobin Following Treatment With Daprodustat and rhEPO
Period 1, DAY 28
|
-5.0 Grams per liter (g/L)
Standard Deviation 5.87
|
3.5 Grams per liter (g/L)
Standard Deviation 3.39
|
|
Periods 1 and 2: Change From Baseline in Hemoglobin Following Treatment With Daprodustat and rhEPO
Period 2, DAY 14
|
-5.3 Grams per liter (g/L)
Standard Deviation 4.80
|
3.7 Grams per liter (g/L)
Standard Deviation 3.01
|
|
Periods 1 and 2: Change From Baseline in Hemoglobin Following Treatment With Daprodustat and rhEPO
Period 2, DAY 28
|
-4.3 Grams per liter (g/L)
Standard Deviation 10.19
|
2.3 Grams per liter (g/L)
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)Population: Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Daprodustat
n=12 Participants
Participants were randomly assigned to receive Daprodustat in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
rhEPO
n=12 Participants
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
|---|---|---|
|
Periods 1 and 2: Change From Baseline in Hematocrit Following Treatment With Daprodustat and rhEPO
Period 1, DAY 14
|
0.002 Proportion of red blood cells in blood
Standard Deviation 0.0086
|
0.011 Proportion of red blood cells in blood
Standard Deviation 0.0144
|
|
Periods 1 and 2: Change From Baseline in Hematocrit Following Treatment With Daprodustat and rhEPO
Period 1, DAY 28
|
-0.017 Proportion of red blood cells in blood
Standard Deviation 0.0183
|
0.009 Proportion of red blood cells in blood
Standard Deviation 0.0139
|
|
Periods 1 and 2: Change From Baseline in Hematocrit Following Treatment With Daprodustat and rhEPO
Period 2, DAY 14
|
-0.006 Proportion of red blood cells in blood
Standard Deviation 0.0205
|
0.009 Proportion of red blood cells in blood
Standard Deviation 0.0105
|
|
Periods 1 and 2: Change From Baseline in Hematocrit Following Treatment With Daprodustat and rhEPO
Period 2, DAY 28
|
-0.010 Proportion of red blood cells in blood
Standard Deviation 0.0343
|
0.002 Proportion of red blood cells in blood
Standard Deviation 0.0114
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)Population: Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Daprodustat
n=12 Participants
Participants were randomly assigned to receive Daprodustat in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
rhEPO
n=12 Participants
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
|---|---|---|
|
Periods 1 and 2: Change From Baseline in Erythrocytes Following Treatment With Daprodustat and rhEPO
Period 1, DAY 14
|
0.05 10^12 cells/liter
Standard Deviation 0.138
|
0.13 10^12 cells/liter
Standard Deviation 0.137
|
|
Periods 1 and 2: Change From Baseline in Erythrocytes Following Treatment With Daprodustat and rhEPO
Period 1, DAY 28
|
-0.13 10^12 cells/liter
Standard Deviation 0.163
|
0.13 10^12 cells/liter
Standard Deviation 0.082
|
|
Periods 1 and 2: Change From Baseline in Erythrocytes Following Treatment With Daprodustat and rhEPO
Period 2, DAY 14
|
-0.17 10^12 cells/liter
Standard Deviation 0.225
|
0.13 10^12 cells/liter
Standard Deviation 0.121
|
|
Periods 1 and 2: Change From Baseline in Erythrocytes Following Treatment With Daprodustat and rhEPO
Period 2, DAY 28
|
-0.13 10^12 cells/liter
Standard Deviation 0.367
|
0.07 10^12 cells/liter
Standard Deviation 0.151
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)Population: Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Daprodustat
n=12 Participants
Participants were randomly assigned to receive Daprodustat in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
rhEPO
n=12 Participants
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
|---|---|---|
|
Periods 1 and 2: Change From Baseline in Erythrocyte Mean Corpuscular Volume Following Treatment With Daprodustat and rhEPO
Period 1, DAY 14
|
-0.8 Femtoliter (fL)
Standard Deviation 3.25
|
-0.5 Femtoliter (fL)
Standard Deviation 2.43
|
|
Periods 1 and 2: Change From Baseline in Erythrocyte Mean Corpuscular Volume Following Treatment With Daprodustat and rhEPO
Period 1, DAY 28
|
-1.5 Femtoliter (fL)
Standard Deviation 3.45
|
-0.8 Femtoliter (fL)
Standard Deviation 2.71
|
|
Periods 1 and 2: Change From Baseline in Erythrocyte Mean Corpuscular Volume Following Treatment With Daprodustat and rhEPO
Period 2, DAY 14
|
2.8 Femtoliter (fL)
Standard Deviation 4.17
|
-0.3 Femtoliter (fL)
Standard Deviation 3.72
|
|
Periods 1 and 2: Change From Baseline in Erythrocyte Mean Corpuscular Volume Following Treatment With Daprodustat and rhEPO
Period 2, DAY 28
|
0.3 Femtoliter (fL)
Standard Deviation 1.97
|
-0.8 Femtoliter (fL)
Standard Deviation 3.31
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)Population: Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Daprodustat
n=12 Participants
Participants were randomly assigned to receive Daprodustat in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
rhEPO
n=12 Participants
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
|---|---|---|
|
Periods 1 and 2: Change From Baseline in Reticulocyte Hemoglobin Following Treatment of Daprodustat and rhEPO
Period 1, DAY 14
|
0.333 Picogram (pg)
Standard Deviation 1.4334
|
-0.033 Picogram (pg)
Standard Deviation 0.5888
|
|
Periods 1 and 2: Change From Baseline in Reticulocyte Hemoglobin Following Treatment of Daprodustat and rhEPO
Period 1, DAY 28
|
0.250 Picogram (pg)
Standard Deviation 1.3925
|
0.717 Picogram (pg)
Standard Deviation 0.6882
|
|
Periods 1 and 2: Change From Baseline in Reticulocyte Hemoglobin Following Treatment of Daprodustat and rhEPO
Period 2, DAY 14
|
0.817 Picogram (pg)
Standard Deviation 1.5433
|
-0.350 Picogram (pg)
Standard Deviation 0.7450
|
|
Periods 1 and 2: Change From Baseline in Reticulocyte Hemoglobin Following Treatment of Daprodustat and rhEPO
Period 2, DAY 28
|
1.083 Picogram (pg)
Standard Deviation 0.8819
|
-0.117 Picogram (pg)
Standard Deviation 0.9948
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)Population: Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Daprodustat
n=12 Participants
Participants were randomly assigned to receive Daprodustat in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
rhEPO
n=12 Participants
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1 or 2. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of study treatment. There was no washout period between treatment periods.
|
|---|---|---|
|
Periods 1 and 2: Change From Baseline in Reticulocytes Following Treatment With Daprodustat and rhEPO
Period 1, DAY 28
|
0.004 10^12 cells/liter
Standard Deviation 0.0169
|
-0.004 10^12 cells/liter
Standard Deviation 0.0135
|
|
Periods 1 and 2: Change From Baseline in Reticulocytes Following Treatment With Daprodustat and rhEPO
Period 1, DAY 14
|
0.001 10^12 cells/liter
Standard Deviation 0.0155
|
0.002 10^12 cells/liter
Standard Deviation 0.0090
|
|
Periods 1 and 2: Change From Baseline in Reticulocytes Following Treatment With Daprodustat and rhEPO
Period 2, DAY 14
|
0.004 10^12 cells/liter
Standard Deviation 0.0088
|
-0.005 10^12 cells/liter
Standard Deviation 0.0216
|
|
Periods 1 and 2: Change From Baseline in Reticulocytes Following Treatment With Daprodustat and rhEPO
Period 2, DAY 28
|
0.020 10^12 cells/liter
Standard Deviation 0.0099
|
-0.010 10^12 cells/liter
Standard Deviation 0.0213
|
Adverse Events
Daprodustat in Period 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
rhEPO in Period 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
rhEPO in Period 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Daprodustat in Period 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daprodustat in Period 1
n=7 participants at risk
Participants were randomly assigned to receive Daprodustat in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of randomized study treatment. Participants were advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: H2 receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency.
|
rhEPO in Period 1
n=7 participants at risk
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of randomized study treatment. Participants were advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: Histamine \[H2\] receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency.
|
rhEPO in Period 2
n=7 participants at risk
At Day 29 participants were crossed over to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 2. At 2 weeks following initiation of dosing in Treatment Period 2, participants were again administered ferrous sulfate containing the stable iron isotope (58Fe or 57Fe). Participants were advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: H2 receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency.
|
Daprodustat in Period 2
n=7 participants at risk
At Day 29 participants were crossed over to receive Daprodustat in Treatment Period 2. At 2 weeks following initiation of dosing in Treatment Period 2, participants were again administered ferrous sulfate containing the stable iron isotope (58Fe or 57Fe). Participants were advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: H2 receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency.
|
|---|---|---|---|---|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
Other adverse events
| Measure |
Daprodustat in Period 1
n=7 participants at risk
Participants were randomly assigned to receive Daprodustat in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of randomized study treatment. Participants were advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: H2 receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency.
|
rhEPO in Period 1
n=7 participants at risk
Participants were randomly assigned to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants were administered ferrous sulfate containing a stable isotope of iron (57Fe or 58Fe) in a randomized fashion following 2 weeks of administration of randomized study treatment. Participants were advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: Histamine \[H2\] receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency.
|
rhEPO in Period 2
n=7 participants at risk
At Day 29 participants were crossed over to receive rhEPO (i.e., epoetin alfa or darbepoetin alfa) in Treatment Period 2. At 2 weeks following initiation of dosing in Treatment Period 2, participants were again administered ferrous sulfate containing the stable iron isotope (58Fe or 57Fe). Participants were advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: H2 receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency.
|
Daprodustat in Period 2
n=7 participants at risk
At Day 29 participants were crossed over to receive Daprodustat in Treatment Period 2. At 2 weeks following initiation of dosing in Treatment Period 2, participants were again administered ferrous sulfate containing the stable iron isotope (58Fe or 57Fe). Participants were advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: H2 receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Eye disorders
Retinal haemorrhage
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Infections and infestations
COVID-19
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Infections and infestations
Sinusitis
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
42.9%
3/7 • Number of events 3 • All-cause mortality, SAEs and non-serious AEs were collected up to Day 73
Safety population comprised of all randomized participants who received at least one dose of study treatment. AEs were presented treatment wise. Participants were followed up for ±3 days following the final sample for assessment of red blood cell iron.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER