A Phase 2 interventional study of Daprodustat and rhEPO in Anaemia, sponsored by GlaxoSmithKline. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-27.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
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Among 30 studies testing GSK1278863 in Anemia — 1 open to participants now, 1 under way, 1 of them phase 3. GSK1278863 · Anemia.
Among the 30 studies testing GSK1278863 in Anemia, this one is the 25th largest by enrollment, is one of 2 that started in 2019, is one of 10 in phase 2, and was the 25th registered.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
Browse Anemia studies →1 of the 30 studies testing GSK1278863 in Anemia is open now. Recruiting first, the newest first:
GSK1278863: first FDA approval 2023 (JESDUVROQ). What it is approved for, and how studies give it, is on its page →
Of the 122 Anemia studies recruiting now, 67 (55%) set no upper age limit and 37 (30%) stop at 75 or younger; 34 take children under 18; 23 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
30 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 2 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 15 is below the median of 117 across 1,336 interventional studies indexed under Anemia.
Median enrollment 76 across the 30 interventional studies. Of the 29 that completed or were terminated, 23 (79%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 30 have an industry lead sponsor. The 3 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
35 studies in Anemia by GlaxoSmithKline: none open now, none under way, none of them phase 3. Of 35 finished, 25 (71%) have results posted.
Among the 35 studies in Anemia by GlaxoSmithKline, this one is the 30th largest by enrollment, is one of 2 that started in 2019, is one of 11 in phase 2, and was the 31st registered.
GlaxoSmithKline’s Anemia studies by the year they started, since 2006.
1 of the studies testing GSK1278863 in Anemia that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07300111Phase 3Qilu Pharmaceutical Co., Ltd.A Study to Evaluate Efficacy and Safety of QLG1218(Daprodustat) in Chinese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD) | 2027-05 |
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Among the 30 studies testing GSK1278863 in Anemia, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among GlaxoSmithKline’s 35 in Anemia:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Daprodustat administration has the potential, by virtue of increasing hypoxia-inducible factor (HIF) levels, to increase oral iron absorption and incorporation into hemoglobin (Hgb). Therefore, the purpose of this study is to compare the effect of daprodustat to rhEPO (i.e., epoetin alfa or darbepoetin alfa) on non-heme oral iron absorption using stable isotopic iron (57Fe and 58Fe) by measuring incorporation of iron in erythrocytes. This study will be a randomized, repeat dose, open label, two period cross-over study in adult, male and female participants with anemia associated with chronic kidney disease who are not on dialysis currently treated with stable doses less than or equal to (\<=) 50 percent (%) change in 4-weekly dose) for at least 8 weeks prior to and including the screening period, of rhEPO (i.e., epoetin alfa or darbepoetin alfa). Sufficient participants will be enrolled such that at least 12 participants comprise the Evaluable Population. The study will compare the fractional iron absorption between treatment arms (daprodustat and rhEPO [i.e., epoetin alfa or darbepoetin alfa]) and will evaluate the difference is equal/not equal to zero.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be randomly assigned to remain on their current therapy (either epoetin alfa or darbepoetin alfa) in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants will be administered ferrous sulfate containing a stable isotope of iron (57Fe) orally in a randomized fashion following 2 weeks of administration of randomized study treatment. At Day 29 participants will be crossed over to receive Daprodustat in Treatment Period 2. At 2 weeks following initiation of dosing in Treatment Period 2, participants will again be administered ferrous sulfate containing the stable iron isotope (58Fe) orally. Participants will be 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.
Drug: Daprodustat · Drug: rhEPO · Drug: Ferrous sulfate containing the stable iron isotope (57Fe) · Drug: Ferrous sulfate containing the stable iron isotope (58Fe)
Participants will be randomly assigned to remain on their current therapy (either epoetin alfa or darbepoetin alfa) in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants will be administered ferrous sulfate containing a stable isotope of iron (58Fe) orally in a randomized fashion following 2 weeks of administration of randomized study treatment. At Day 29 participants will be crossed over to receive Daprodustat in Treatment Period 2. At 2 weeks following initiation of dosing in Treatment Period 2, participants will again be administered ferrous sulfate containing the stable iron isotope (57Fe) orally. Participants will be 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.
Drug: Daprodustat · Drug: rhEPO · Drug: Ferrous sulfate containing the stable iron isotope (57Fe) · Drug: Ferrous sulfate containing the stable iron isotope (58Fe)
Participants will be randomly assigned to receive Daprodustat in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants will be administered ferrous sulfate containing a stable isotope of iron (57Fe) orally in a randomized fashion following 2 weeks of administration of randomized study treatment. At Day 29 participants will be 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 will again be administered ferrous sulfate containing the stable iron isotope (58Fe) orally. Participants will be 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.
Drug: Daprodustat · Drug: rhEPO · Drug: Ferrous sulfate containing the stable iron isotope (57Fe) · Drug: Ferrous sulfate containing the stable iron isotope (58Fe)
Participants will be randomly assigned to receive Daprodustat in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants will be administered ferrous sulfate containing a stable isotope of iron (58Fe) orally in a randomized fashion following 2 weeks of administration of randomized study treatment. At Day 29 participants will be 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 will again be administered ferrous sulfate containing the stable iron isotope (57Fe) orally. Participants will be 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.
Drug: Daprodustat · Drug: rhEPO · Drug: Ferrous sulfate containing the stable iron isotope (57Fe) · Drug: Ferrous sulfate containing the stable iron isotope (58Fe)
Daprodustat will be available as 1 milligram (mg), 2 mg and 4 mg tablets strengths. One tablet to be taken daily without regard for food.
rhEPO (epoetin alfa OR darbepoetin alfa) is commercially available in various single dose vials and single-dose prefilled syringes. It will be given as subcutaneous injection.
57Fe will be available in oral solution. An oral solution will be administered containing 10 mg of 57Fe as ferrous sulfate.
58Fe will be available in oral solution. An oral solution will be administered containing 3 mg of 58Fe as ferrous sulfate with 7 mg of 56Fe as ferrous sulfate (natural abundance Fe).
Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO
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.
Time frame: Up to Day 57
Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO
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.
Time frame: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
Period 1 and 2: Change From Baseline in Transferrin Following Treatment With Daprodustat or rhEPO
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.
Time frame: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
Periods 1 and 2: Change From Baseline in Transferrin Saturation Following Treatment With Daprodustat or rhEPO
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.
Time frame: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
Periods 1 and 2: Change From Baseline in Soluble Transferrin Receptor Following Treatment of Daprodustat and rhEPO
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.
Time frame: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
Periods 1 and 2: Ratio to Baseline in Ferritin Following Treatment With Daprodustat and rhEPO
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.
Time frame: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
Periods 1 and 2: Ratio to Baseline (Day 1) in Hepcidin Following Treatment With Daprodustat and rhEPO
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.
Time frame: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
Periods 1 and 2: Change From Baseline in Erythroferrone Following Treatment With Daprodustat and rhEPO
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.
Time frame: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
Periods 1 and 2: Change From Baseline in Hemoglobin Following Treatment With Daprodustat and rhEPO
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.
Time frame: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
Periods 1 and 2: Change From Baseline in Hematocrit Following Treatment With Daprodustat and rhEPO
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.
Time frame: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
Periods 1 and 2: Change From Baseline in Erythrocytes Following Treatment With Daprodustat and rhEPO
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.
Time frame: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
Periods 1 and 2: Change From Baseline in Erythrocyte Mean Corpuscular Volume Following Treatment With Daprodustat and rhEPO
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.
Time frame: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
Periods 1 and 2: Change From Baseline in Reticulocyte Hemoglobin Following Treatment of Daprodustat and rhEPO
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.
Time frame: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
Periods 1 and 2: Change From Baseline in Reticulocytes Following Treatment With Daprodustat and rhEPO
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.
Time frame: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
This was a two-period cross over study to compare the effect of Daprodustat to recombinant, human erythropoietin (rhEPO) on oral iron absorption.
| Milestone | Daprodustat Followed by rhEPO | rhEPO Followed by Daprodustat |
|---|---|---|
| Started | 7 | 8 |
| Safety population | 7 | 7 |
| Completed | 6 | 7 |
| Not completed | 1 | 1 |
| Withdrew: Participant reached protocol-defined stopping criteria | 1 | 1 |
| Milestone | Daprodustat Followed by rhEPO | rhEPO Followed by Daprodustat |
|---|---|---|
| Started | 6 | 7 |
| Completed | 6 | 6 |
| Not completed | 0 | 1 |
| Withdrew: Participant reached protocol-defined stopping criteria | 0 | 1 |
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.
| Percentage (%) of iron absorbed | Daprodustat | rhEPO |
|---|---|---|
| Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO | 20.64 (10.96 to 30.32) | 20.62 (10.95 to 30.30) |
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.
| Micromoles per liter (umol/L) | Daprodustat | rhEPO |
|---|---|---|
| Period 1, DAY 14 | -1.5 ± 6.72 | 1.7 ± 4.93 |
| Period 1, DAY 28 | 2.5 ± 8.96 | 3.3 ± 5.47 |
| Period 2, DAY 14 | -1.3 ± 4.93 | -3.5 ± 6.66 |
| Period 2, DAY 28 | -2.2 ± 4.79 | -3.3 ± 5.01 |
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.
| Gram per Liter (g/L) | Daprodustat | rhEPO |
|---|---|---|
| Period 1, DAY 14 | 0.182 ± 0.2914 | 0.145 ± 0.2501 |
| Period 1, DAY 28 | 0.283 ± 0.2824 | -0.040 ± 0.1756 |
| Period 2, DAY 14 | -0.177 ± 0.4664 | -0.163 ± 0.2461 |
| Period 2, DAY 28 | 0.138 ± 0.2381 | -0.352 ± 0.2531 |
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.
| Percentage (%) of transferrin saturation | Daprodustat | rhEPO |
|---|---|---|
| Period 1, DAY 14 | -5.2 ± 13.63 | 3.5 ± 12.05 |
| Period 1, DAY 28 | 3.0 ± 18.13 | 8.2 ± 14.41 |
| Period 2, DAY 14 | -5.5 ± 13.40 | -4.8 ± 10.98 |
| Period 2, DAY 28 | -6.7 ± 14.57 | -4.7 ± 11.29 |
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.
| Milligrams per liter (mg/L) | Daprodustat | rhEPO |
|---|---|---|
| Period 1, DAY 14 | -0.218 ± 0.1736 | 0.063 ± 0.1669 |
| Period 1, DAY 28 | -0.340 ± 0.2665 | -0.015 ± 0.1598 |
| Period 2, DAY 14 | -0.338 ± 0.2978 | 0.227 ± 0.1086 |
| Period 2, DAY 28 | -0.308 ± 0.3180 | 0.195 ± 0.2239 |
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.
| Microgram per liter (ug/L) | Daprodustat | rhEPO |
|---|---|---|
| Period 1, DAY 14 | 1.126 ± 20.1853 | 0.937 ± 16.2891 |
| Period 1, DAY 28 | 1.109 ± 24.7052 | 1.004 ± 5.4818 |
| Period 2, DAY 14 | 1.067 ± 32.7697 | 0.957 ± 20.2623 |
| Period 2, DAY 28 | 1.278 ± 53.1128 | 0.911 ± 23.5414 |
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.
| Microgram per liter (ug/L) | Daprodustat | rhEPO |
|---|---|---|
| Period 1, DAY 14 | 0.860 ± 86.4844 | 0.904 ± 52.1384 |
| Period 1, DAY 28 | 0.916 ± 61.2898 | 1.052 ± 27.7868 |
| Period 2, DAY 14 | 0.703 ± 74.4694 | 1.201 ± 63.6067 |
| Period 2, DAY 28 | 0.802 ± 73.5598 | 1.306 ± 47.6931 |
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.
| Microgram per liter (ug/L) | Daprodustat | rhEPO |
|---|---|---|
| Period 1, DAY 14 | 0.135 ± 0.3086 | -0.062 ± 0.1824 |
| Period 1, DAY 28 | 0.075 ± 0.2544 | -0.090 ± 0.1380 |
| Period 2, DAY 14 | 0.063 ± 0.2225 | -0.068 ± 0.2405 |
| Period 2, DAY 28 | 0.032 ± 0.3578 | -0.110 ± 0.2278 |
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.
| Grams per liter (g/L) | Daprodustat | rhEPO |
|---|---|---|
| Period 1, DAY 14 | 0.7 ± 3.67 | 2.8 ± 2.99 |
| Period 1, DAY 28 | -5.0 ± 5.87 | 3.5 ± 3.39 |
| Period 2, DAY 14 | -5.3 ± 4.80 | 3.7 ± 3.01 |
| Period 2, DAY 28 | -4.3 ± 10.19 | 2.3 ± 2.94 |
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.
| Proportion of red blood cells in blood | Daprodustat | rhEPO |
|---|---|---|
| Period 1, DAY 14 | 0.002 ± 0.0086 | 0.011 ± 0.0144 |
| Period 1, DAY 28 | -0.017 ± 0.0183 | 0.009 ± 0.0139 |
| Period 2, DAY 14 | -0.006 ± 0.0205 | 0.009 ± 0.0105 |
| Period 2, DAY 28 | -0.010 ± 0.0343 | 0.002 ± 0.0114 |
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.
| 10^12 cells/liter | Daprodustat | rhEPO |
|---|---|---|
| Period 1, DAY 14 | 0.05 ± 0.138 | 0.13 ± 0.137 |
| Period 1, DAY 28 | -0.13 ± 0.163 | 0.13 ± 0.082 |
| Period 2, DAY 14 | -0.17 ± 0.225 | 0.13 ± 0.121 |
| Period 2, DAY 28 | -0.13 ± 0.367 | 0.07 ± 0.151 |
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.
| Femtoliter (fL) | Daprodustat | rhEPO |
|---|---|---|
| Period 1, DAY 14 | -0.8 ± 3.25 | -0.5 ± 2.43 |
| Period 1, DAY 28 | -1.5 ± 3.45 | -0.8 ± 2.71 |
| Period 2, DAY 14 | 2.8 ± 4.17 | -0.3 ± 3.72 |
| Period 2, DAY 28 | 0.3 ± 1.97 | -0.8 ± 3.31 |
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.
| Picogram (pg) | Daprodustat | rhEPO |
|---|---|---|
| Period 1, DAY 14 | 0.333 ± 1.4334 | -0.033 ± 0.5888 |
| Period 1, DAY 28 | 0.250 ± 1.3925 | 0.717 ± 0.6882 |
| Period 2, DAY 14 | 0.817 ± 1.5433 | -0.350 ± 0.7450 |
| Period 2, DAY 28 | 1.083 ± 0.8819 | -0.117 ± 0.9948 |
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.
| 10^12 cells/liter | Daprodustat | rhEPO |
|---|---|---|
| Period 1, DAY 14 | 0.001 ± 0.0155 | 0.002 ± 0.0090 |
| Period 1, DAY 28 | 0.004 ± 0.0169 | -0.004 ± 0.0135 |
| Period 2, DAY 14 | 0.004 ± 0.0088 | -0.005 ± 0.0216 |
| Period 2, DAY 28 | 0.020 ± 0.0099 | -0.010 ± 0.0213 |
Collected over All-cause mortality, SAEs and non-serious AEs were collected up to Day 73. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Daprodustat in Period 1 | 0/7 (0%) | 0/7 (0%) | 3/7 (42.9%) |
| rhEPO in Period 1 | 0/7 (0%) | 1/7 (14.3%) | 3/7 (42.9%) |
| rhEPO in Period 2 | 0/7 (0%) | 0/7 (0%) | 2/7 (28.6%) |
| Daprodustat in Period 2 | 0/7 (0%) | 1/7 (14.3%) | 3/7 (42.9%) |
| Event | Daprodustat in Period 1 | rhEPO in Period 1 | rhEPO in Period 2 | Daprodustat in Period 2 |
|---|---|---|---|---|
| Cholecystitis infectiveInfections and infestations | 0/7 | 1/7 | 0/7 | 0/7 |
| HyperkalaemiaMetabolism and nutrition disorders | 0/7 | 0/7 | 0/7 | 1/7 |
| Lumbar spinal stenosisMusculoskeletal and connective tissue disorders | 0/7 | 0/7 | 0/7 | 1/7 |
| Event | Daprodustat in Period 1 | rhEPO in Period 1 | rhEPO in Period 2 | Daprodustat in Period 2 |
|---|---|---|---|---|
| HypertensionVascular disorders | 0/7 | 0/7 | 0/7 | 3/7 |
| COVID-19Infections and infestations | 0/7 | 0/7 | 0/7 | 2/7 |
| HypoacusisEar and labyrinth disorders | 0/7 | 1/7 | 0/7 | 0/7 |
| VertigoEar and labyrinth disorders | 0/7 | 1/7 | 0/7 | 0/7 |
| Retinal haemorrhageEye disorders | 1/7 | 0/7 | 0/7 | 0/7 |
| NauseaGastrointestinal disorders | 0/7 | 0/7 | 0/7 | 1/7 |
| BronchitisInfections and infestations | 0/7 | 1/7 | 0/7 | 0/7 |
| Cholecystitis infectiveInfections and infestations | 0/7 | 1/7 | 0/7 | 0/7 |
| SinusitisInfections and infestations | 1/7 | 0/7 | 0/7 | 0/7 |
| Tooth infectionInfections and infestations | 0/7 | 0/7 | 1/7 | 0/7 |
Safety population comprised of participants who received at least 1 dose of study treatment.
| Age, Continuous(Years) | Daprodustat Followed by rhEPO | rhEPO Followed by Daprodustat | Total |
|---|---|---|---|
| Mean | 66.3 ± 5.35 | 64.6 ± 13.88 | 65.4 ± 10.14 |
| Sex: Female, Male(Participants) | Daprodustat Followed by rhEPO | rhEPO Followed by Daprodustat | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 1 | 2 | 3 |
| Race/Ethnicity, Customized(Participants) | Daprodustat Followed by rhEPO | rhEPO Followed by Daprodustat | Total |
|---|---|---|---|
| White/Caucasian/European Heritage | 7 | 7 | 14 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months .
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Jul 2019 to primary completion in Jul 2022, 35 months.
Results were first posted in Jul 2023, 1 year after primary completion.
Of 58 industry-sponsored phase 2 interventional studies under Anemia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 40. This study's 35 months is above that.
Counting every sponsor, half of 88 studies reached it within 28 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: GSK1278863 · Erythropoietin