A Phase 3 interventional study of Daprodustat tablets and Matching placebo tablets in Anaemia, sponsored by GlaxoSmithKline. Completed at 91 sites in 13 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-07-12.
Sponsored by GlaxoSmithKline · Phase 3, 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 4th largest by enrollment, is one of 3 that started in 2018, is one of 9 in phase 3, and was the 22nd 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 to 99 Years · 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. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 407 is above 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 4th largest by enrollment, is one of 3 that started in 2018, is one of 10 in phase 3, and was the 28th 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.
This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.
Drug: Daprodustat tablets · Drug: Saline vials or bags
Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.
Drug: Matching placebo tablets · Drug: Epoetin alfa vials
Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.
Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.
Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.
0.9% sodium chloride saline vials or bags administered by the IV route.
Mean Change From Baseline in Hemoglobin Levels Over the Evaluation Period (Week 28 to Week 52)
Blood samples were collected from participants for hemoglobin measurements. Hemoglobin during the evaluation period was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis, the missing post-Baseline hemoglobin values were imputed using pre-specified multiple imputations. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Analysis was performed using the Analysis of Covariance (ANCOVA) model with terms for treatment, Baseline hemoglobin, and region.
Time frame: Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)
Mean Average Monthly On-treatment Intravenous (IV) Iron Dose Per Participant
Average monthly IV iron dose (mg) per participant during Day 1 to Week 52 was determined by calculating the total IV iron dose per participant from Day 1 to Week 52 while the participant was on study treatment and dividing by (the number of days the participant was on study treatment divided by 30.4375 days). Analysis was performed using the ANCOVA model with terms for treatment, Baseline monthly IV iron dose, and region.
Time frame: Day 1 to Week 52
Change From Baseline in Hemoglobin Levels at Week 52
Blood samples were collected from participants for hemoglobin measurements. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the post-randomization visit value minus Baseline value. Analysis was performed using a mixed model repeated measures (MMRM) model fitted to hemoglobin data collected after Baseline up to Week 52, excluding values collected during the stabilization period (Day 1 to Week 28). The model included factors for treatment, time, region, Baseline hemoglobin and Baseline hemoglobin by time and treatment by time interaction terms.
Time frame: Baseline (Pre-dose on Day 1) and Week 52
Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52)
Participants received treatment during the study to achieve or maintain hemoglobin level in the target range. Percentage of time for which hemoglobin level was maintained within the analysis range (10 to 11.5 grams/deciliter) has been presented.
Time frame: Week 28 to Week 52
Number of Hemoglobin Responders in the Hemoglobin Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52)
Mean hemoglobin during the evaluation period was defined as the mean of all evaluable hemoglobin values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled hemoglobin values that were taken during this time period. Hemoglobin responders were defined as the number of participants with a mean hemoglobin during the evaluation period that falls within the hemoglobin analysis range of 10-11.5 grams/deciliter.
Time frame: Week 28 to Week 52
Percentage of Participants Permanently Stopping Study Treatment Due to Meeting Rescue Criteria
Percentage of participants permanently stopping study treatment due to meeting rescue criteria has been presented.
Time frame: Up to Week 52
Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP) at Week 52
Measurements for SBP, DBP and MAP were taken with the participant in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period. MAP is the average BP in an individual's arteries during a single cardiac cycle. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the on-treatment visit value minus Baseline value. Analysis was performed using MMRM model with treatment group, time, region, Baseline value, Baseline value\*time, treatment group\*time as variables.
Time frame: Baseline (Week -4 ) and Week 52
Change From Baseline in SBP, DBP and MAP at End of Treatment
Measurements for SBP, DBP and MAP were taken with the participant in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period. MAP is the average BP in an individual's arteries during a single cardiac cycle. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the last on-treatment visit value minus Baseline value. Analysis was performed using ANCOVA model with terms for treatment group, region and Baseline value. Adjusted mean and standard error have been presented.
Time frame: Baseline (Week -4) and end of treatment (last on-treatment value until Week 52)
Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years
BP exacerbation event is defined (based on post-dialysis BP) as SBP \>=25 mmHg increased from Baseline or SBP \>=180 mmHg; or DBP \>=15 mmHg increased from Baseline or DBP \>=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the Negative Binomial Model.
Time frame: Up to 52 weeks
Number of Participants With at Least One BP Exacerbation Event During the Study
BP exacerbation (based on post-dialysis BP) is defined as: SBP \>= 25 mmHg increased from Baseline or SBP \>=180mmHg; or DBP \>=15 mmHg increase from Baseline or DBP \>=110 mmHg. Number of participants with at least 1 BP exacerbation event have been reported.
Time frame: Up to 52 weeks
Change From Baseline at Weeks 8, 12, 28 and 52 in Patient Global Impression of Severity (PGI-S)
The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity of their anemia of Chronic kidney disease (CKD). It is measured on a 5-point disease severity scale ranging from 0 (absent) to 4 (very severe), higher score indicates more disease severity. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline in on-treatment PGI-S scores was defined as the on-treatment visit value minus Baseline value. Analysis was performed using MMRM model fitted from Baseline up to Week 52 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.
Time frame: Baseline (Pre-dose on Day 1) and Weeks 8, 12, 28, 52
Pre-dose Trough Concentration (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13)
Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites: GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13).
Time frame: Pre-dose on Day 1; Pre-dose and at 0.5, 1, 2, 3 hours post-dose on any one post-Baseline visit day between Week 8 and Week 52
Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13)
Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites: GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13).
Time frame: Pre-dose on Day 1; Pre-dose and at 0.5, 1, 2, 3 hours post-dose on any one post-Baseline visit day between Week 8 and Week 52
This was a multicenter study conducted at 90 centers in 13 countries. Participants were randomized to receive either Daprodustat or Epoetin alfa.
| Milestone | Daprodustat | Epoetin Alfa |
|---|---|---|
| Started | 270 | 137 |
| Completed | 269 | 135 |
| Not completed | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 2 |
Blood samples were collected from participants for hemoglobin measurements. Hemoglobin during the evaluation period was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis, the missing post-Baseline hemoglobin values were imputed using pre-specified multiple imputations. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Analysis was performed using the Analysis of Covariance (ANCOVA) model with terms for treatment, Baseline hemoglobin, and region.
| Grams per deciliter (g/dL) | Daprodustat | Epoetin Alfa |
|---|---|---|
| Mean Change From Baseline in Hemoglobin Levels Over the Evaluation Period (Week 28 to Week 52) | -0.04 ± 0.045 | 0.02 ± 0.066 |
Average monthly IV iron dose (mg) per participant during Day 1 to Week 52 was determined by calculating the total IV iron dose per participant from Day 1 to Week 52 while the participant was on study treatment and dividing by (the number of days the participant was on study treatment divided by 30.4375 days). Analysis was performed using the ANCOVA model with terms for treatment, Baseline monthly IV iron dose, and region.
| Milligrams | Daprodustat | Epoetin Alfa |
|---|---|---|
| Mean Average Monthly On-treatment Intravenous (IV) Iron Dose Per Participant | 98.11 ± 11.049 | 106.23 ± 15.569 |
Blood samples were collected from participants for hemoglobin measurements. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the post-randomization visit value minus Baseline value. Analysis was performed using a mixed model repeated measures (MMRM) model fitted to hemoglobin data collected after Baseline up to Week 52, excluding values collected during the stabilization period (Day 1 to Week 28). The model included factors for treatment, time, region, Baseline hemoglobin and Baseline hemoglobin by time and treatment by time interaction terms.
| Grams per deciliter | Daprodustat | Epoetin Alfa |
|---|---|---|
| Change From Baseline in Hemoglobin Levels at Week 52 | -0.03 ± 0.069 | 0.11 ± 0.098 |
Participants received treatment during the study to achieve or maintain hemoglobin level in the target range. Percentage of time for which hemoglobin level was maintained within the analysis range (10 to 11.5 grams/deciliter) has been presented.
| Percentage of days | Daprodustat | Epoetin Alfa |
|---|---|---|
| Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52) | 70.83 (50.98 to 91.07) | 61.76 (29.69 to 85.19) |
Mean hemoglobin during the evaluation period was defined as the mean of all evaluable hemoglobin values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled hemoglobin values that were taken during this time period. Hemoglobin responders were defined as the number of participants with a mean hemoglobin during the evaluation period that falls within the hemoglobin analysis range of 10-11.5 grams/deciliter.
| Participants | Daprodustat | Epoetin Alfa |
|---|---|---|
| Number of Hemoglobin Responders in the Hemoglobin Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52) | 172 | 68 |
Percentage of participants permanently stopping study treatment due to meeting rescue criteria has been presented.
| Percentage of participants | Daprodustat | Epoetin Alfa |
|---|---|---|
| Percentage of Participants Permanently Stopping Study Treatment Due to Meeting Rescue Criteria | 2.2 | 2.2 |
Measurements for SBP, DBP and MAP were taken with the participant in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period. MAP is the average BP in an individual's arteries during a single cardiac cycle. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the on-treatment visit value minus Baseline value. Analysis was performed using MMRM model with treatment group, time, region, Baseline value, Baseline value\*time, treatment group\*time as variables.
| Millimeter of mercury (mmHg) | Daprodustat | Epoetin Alfa |
|---|---|---|
| SBP | -3.18 ± 1.470 | 0.55 ± 2.252 |
| DBP | -2.52 ± 0.764 | -0.29 ± 1.176 |
| MAP | -2.72 ± 0.907 | -0.12 ± 1.389 |
Measurements for SBP, DBP and MAP were taken with the participant in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period. MAP is the average BP in an individual's arteries during a single cardiac cycle. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the last on-treatment visit value minus Baseline value. Analysis was performed using ANCOVA model with terms for treatment group, region and Baseline value. Adjusted mean and standard error have been presented.
| Millimeter of mercury (mmHg) | Daprodustat | Epoetin Alfa |
|---|---|---|
| SBP | -1.4 ± 1.24 | -0.9 ± 1.75 |
| DBP | -1.8 ± 0.66 | -0.8 ± 0.93 |
| MAP | -1.7 ± 0.78 | -0.8 ± 1.09 |
BP exacerbation event is defined (based on post-dialysis BP) as SBP \>=25 mmHg increased from Baseline or SBP \>=180 mmHg; or DBP \>=15 mmHg increased from Baseline or DBP \>=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the Negative Binomial Model.
| Events per 100 participant years | Daprodustat | Epoetin Alfa |
|---|---|---|
| Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years | 250.45 (210.69 to 297.72) | 356.91 (280.95 to 453.41) |
BP exacerbation (based on post-dialysis BP) is defined as: SBP \>= 25 mmHg increased from Baseline or SBP \>=180mmHg; or DBP \>=15 mmHg increase from Baseline or DBP \>=110 mmHg. Number of participants with at least 1 BP exacerbation event have been reported.
| Participants | Daprodustat | Epoetin Alfa |
|---|---|---|
| Number of Participants With at Least One BP Exacerbation Event During the Study | 151 | 91 |
The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity of their anemia of Chronic kidney disease (CKD). It is measured on a 5-point disease severity scale ranging from 0 (absent) to 4 (very severe), higher score indicates more disease severity. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline in on-treatment PGI-S scores was defined as the on-treatment visit value minus Baseline value. Analysis was performed using MMRM model fitted from Baseline up to Week 52 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.
| Scores on a scale | Daprodustat | Epoetin Alfa |
|---|---|---|
| Week 8; n=248, 126 | -0.10 ± 0.048 | 0.05 ± 0.068 |
| Week 12; n=243, 120 | -0.13 ± 0.050 | -0.01 ± 0.071 |
| Week 28; n=211, 106 | -0.07 ± 0.054 | 0.03 ± 0.077 |
| Week 52; n=170, 85 | -0.11 ± 0.063 | 0.04 ± 0.088 |
Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites: GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13).
| Nanograms per milliliter | Daprodustat 2 mg | Daprodustat 4 mg | Daprodustat 8 mg | Daprodustat 12 mg | Daprodustat 16 mg | Daprodustat 20 mg | Daprodustat 24 mg | Daprodustat 32 mg | Daprodustat 48 mg |
|---|---|---|---|---|---|---|---|---|---|
| Daprodustat; n=1, 2, 10, 18, 14, 9, 6, 3, 2 | 6.2400 ± NA | 1.1207 ± 494.71 | 0.1786 ± 77.35 | 0.3727 ± 277.88 | 0.3443 ± 100.78 | 0.3871 ± 161.05 | 0.1621 ± 42.17 | 0.2768 ± 140.82 | 0.3486 ± 68.34 |
| GSK2391220; n=4, 17,42, 57, 40, 25, 16, 3, 3 | 0.8623 ± 241.17 | 0.5893 ± 255.59 | 0.6341 ± 123.92 | 1.1572 ± 184.51 | 1.1654 ± 191.57 | 1.1792 ± 168.59 | 1.4987 ± 136.35 | 1.6974 ± 6.82 | 1.3531 ± 19.28 |
| GSK2487818; n=1, 4, 5, 20, 14, 7, 4, 3, 2 | 0.3620 ± NA | 0.2867 ± 111.67 | 0.1594 ± 16.91 | 0.2996 ± 105.55 | 0.3027 ± 69.12 | 0.2868 ± 109.23 | 0.2585 ± 30.72 | 0.2414 ± 29.66 | 0.2111 ± 80.56 |
| GSK2506102; n=4, 17, 45, 59, 43, 27, 16, 3, 3 | 0.9951 ± 122.94 | 0.8372 ± 121.27 | 0.9634 ± 95.99 | 1.5100 ± 105.50 | 1.5480 ± 122.95 | 1.6555 ± 133.94 | 3.2099 ± 67.36 | 1.6892 ± 30.44 | 1.8595 ± 48.36 |
| GSK2506104; n=6, 17, 45, 59, 43, 27, 16, 3, 3 | 0.9750 ± 408.49 | 1.9588 ± 163.27 | 2.0381 ± 124.74 | 3.5141 ± 136.72 | 3.3872 ± 182.27 | 3.6000 ± 173.62 | 6.5730 ± 99.82 | 4.2068 ± 15.44 | 4.1894 ± 23.78 |
| GSK2531398; n=2, 7, 22, 41, 33, 20, 15, 3, 3 | 1.1778 ± 20.55 | 0.6069 ± 271.48 | 0.2362 ± 76.76 | 0.4444 ± 144.99 | 0.3917 ± 169.77 | 0.3728 ± 197.51 | 0.3992 ± 153.15 | 0.3963 ± 16.52 | 0.2280 ± 56.68 |
| GSK2531401; n=6, 17, 45, 59, 44, 27, 16, 3, 3 | 1.4466 ± 190.80 | 3.5579 ± 102.68 | 4.0910 ± 148.03 | 6.8137 ± 102.34 | 5.6037 ± 130.97 | 8.4611 ± 128.74 | 11.7372 ± 65.37 | 6.0453 ± 140.63 | 16.2584 ± 41.06 |
Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites: GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13).
| Nanograms per milliliter | Daprodustat 2 mg | Daprodustat 4 mg | Daprodustat 8 mg | Daprodustat 12 mg | Daprodustat 16 mg | Daprodustat 20 mg | Daprodustat 24 mg | Daprodustat 32 mg | Daprodustat 48 mg |
|---|---|---|---|---|---|---|---|---|---|
| Daprodustat; n=8, 20, 49, 57, 45, 28, 16, 3, 3 | 44.5832 ± 227.65 | 51.9261 ± 227.59 | 113.4049 ± 179.69 | 143.8790 ± 233.09 | 126.6824 ± 288.50 | 212.5087 ± 152.47 | 290.3163 ± 87.39 | 197.7071 ± 36.53 | 310.1938 ± 190.69 |
| GSK2391220; n=8, 19, 50, 59, 45, 28, 16, 3, 3 | 2.6298 ± 60.93 | 4.0224 ± 134.91 | 6.3826 ± 198.78 | 8.9535 ± 126.76 | 9.5131 ± 167.92 | 11.8995 ± 172.35 | 22.3378 ± 95.60 | 9.3582 ± 71.78 | 31.6698 ± 84.08 |
| GSK2487818; n=7, 18, 47, 56, 45, 28, 16, 3, 3 | 2.0320 ± 73.45 | 3.2703 ± 143.75 | 6.3474 ± 175.79 | 8.0134 ± 146.43 | 6.4276 ± 278.04 | 9.6617 ± 207.18 | 19.9693 ± 94.09 | 8.4327 ± 64.98 | 29.3042 ± 72.06 |
| GSK2506102; n=8, 19, 51, 59, 45, 28, 16, 3, 3 | 0.8328 ± 101.92 | 1.4018 ± 84.93 | 2.0385 ± 85.59 | 2.8357 ± 68.15 | 3.2007 ± 89.86 | 3.5712 ± 96.48 | 6.4555 ± 59.57 | 2.4981 ± 71.38 | 7.1245 ± 87.62 |
| GSK2506104; n=8, 19, 51, 59, 45, 28, 16, 3, 3 | 3.2020 ± 81.23 | 5.2039 ± 98.70 | 7.5220 ± 131.81 | 10.8186 ± 84.31 | 11.5783 ± 130.74 | 13.8509 ± 125.27 | 24.4926 ± 84.96 | 9.5457 ± 73.58 | 30.4034 ± 79.13 |
| GSK2531398; n=8, 17, 46, 59, 45, 27, 16, 3, 3 | 1.2731 ± 57.92 | 2.3676 ± 84.23 | 3.7348 ± 131.10 | 3.8017 ± 177.36 | 4.0850 ± 209.29 | 6.1029 ± 137.40 | 10.7532 ± 98.46 | 4.6296 ± 72.00 | 14.7844 ± 81.18 |
| GSK2531401; n=7, 19, 51, 59, 45, 28, 16, 3, 3 | 2.0473 ± 100.05 | 4.0012 ± 88.64 | 5.4631 ± 120.63 | 8.8488 ± 80.17 | 8.4814 ± 93.83 | 10.7368 ± 90.83 | 14.7926 ± 59.24 | 7.1458 ± 174.98 | 20.1044 ± 67.56 |
Collected over Treatment emergent serious adverse events (SAEs) and non-serious adverse events (non-serious AEs) were collected up to 52 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Daprodustat | 18/270 (6.7%) | 80/270 (29.6%) | 74/270 (27.4%) |
| Epoetin Alfa | 10/136 (7.4%) | 47/136 (34.6%) | 42/136 (30.9%) |
| Event | Daprodustat | Epoetin Alfa |
|---|---|---|
| PneumoniaInfections and infestations | 9/270 | 5/136 |
| Arteriovenous fistula thrombosisInjury, poisoning and procedural complications | 7/270 | 3/136 |
| Angina unstableCardiac disorders | 0/270 | 3/136 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/270 | 3/136 |
| AnaemiaBlood and lymphatic system disorders | 2/270 | 3/136 |
| Cerebrovascular accidentNervous system disorders | 4/270 | 0/136 |
| Head injuryInjury, poisoning and procedural complications | 2/270 | 2/136 |
| FallInjury, poisoning and procedural complications | 1/270 | 2/136 |
| HypotensionVascular disorders | 1/270 | 2/136 |
| Atrial fibrillationCardiac disorders | 1/270 | 2/136 |
| Event | Daprodustat | Epoetin Alfa |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 23/270 | 14/136 |
| HypertensionVascular disorders | 22/270 | 14/136 |
| VomitingGastrointestinal disorders | 15/270 | 13/136 |
| HeadacheNervous system disorders | 11/270 | 13/136 |
| NauseaGastrointestinal disorders | 6/270 | 11/136 |
| Abdominal painGastrointestinal disorders | 7/270 | 9/136 |
| HypotensionVascular disorders | 12/270 | 9/136 |
| PyrexiaGeneral disorders | 7/270 | 8/136 |
| Age, Customized(Participants) | Daprodustat | Epoetin Alfa | Total |
|---|---|---|---|
| 19-64 Years | 167 | 96 | 263 |
| >= 65 Years | 103 | 41 | 144 |
| Sex: Female, Male(Participants) | Daprodustat | Epoetin Alfa | Total |
|---|---|---|---|
| Female | 121 | 56 | 177 |
| Male | 149 | 81 | 230 |
| Race/Ethnicity, Customized(Participants) | Daprodustat | Epoetin Alfa | Total |
|---|---|---|---|
| BLACK OR AFRICAN AMERICAN | 49 | 32 | 81 |
| AMERICAN INDIAN OR ALASKAN NATIVE | 1 | 1 | 2 |
| ASIAN - CENTRAL/SOUTH ASIAN HERITAGE | 1 | 0 | 1 |
| ASIAN - EAST ASIAN HERITAGE | 16 | 9 | 25 |
| ASIAN - SOUTH EAST ASIAN HERITAGE | 3 | 0 | 3 |
| NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | 1 | 0 | 1 |
| WHITE - ARABIC/NORTH AFRICAN HERITAGE | 1 | 4 | 5 |
| WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE | 193 | 90 | 283 |
| MIXED WHITE RACE | 1 | 0 | 1 |
| MIXED RACE | 1 | 1 | 2 |
| UNKNOWN | 3 | 0 | 3 |
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 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 Sep 2018 to primary completion in Jun 2020, 21 months.
Results were first posted in Jul 2021, 1 year after primary completion.
Of 98 industry-sponsored phase 3 interventional studies under Anemia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 49. This study's 21 months is below that.
Counting every sponsor, half of 150 studies reached it within 30 months; a quarter within 17 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GSK1278863