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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000507-86 | EudraCT Number |
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The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat in subjects with anemia associated with CKD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daprodustat treated anemic subjects | Experimental | Subjects will receive oral daprodustat once daily. |
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| Darbepoetin alfa treated anemic subjects | Active Comparator | Subjects will receive darbepoetin alfa subcutaneously or intravenously. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daprodustat | Drug | Daprodustat will be supplied as film coated tablets for oral administration containing 1, 2, 4, 6, 8, or 10 mg of daprodustat. Doses of 12, 16, and 24 mg of daprodustat will be provided using multiples of these tablet strengths. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52) | Blood samples were collected from participants for Hgb measurement. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputations. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. An analysis of covariance (ANCOVA) model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95 percent (%) confidence interval (CI) for the treatment difference (daprodustat-darbepoetin alfa). | Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Monthly Intravenous Iron Dose (Milligrams) From Baseline to Week 52 | Total IV iron dose per participant was calculated from Day 1 to the earliest of (Week 52 visit date, first blood [red blood cells or whole blood] transfusion date and treatment stop date plus [+] 1 day) which corresponds to the time while the participant was on randomized treatment and before receiving a blood transfusion. Average monthly IV iron dose was calculated by Total IV iron dose divided by (/) (the number of days from Day 1 to the earliest of [Week 52 visit date, first blood transfusion date and treatment stop date +1] /30.4375 days). Data for participants until they underwent a red blood cells or whole blood transfusion was included in the analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Anaheim | California | 92801 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36005278 | Derived | Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2. | |
| 35377393 | Derived | Singh AK, Cizman B, Carroll K, McMurray JJV, Perkovic V, Jha V, Johansen KL, Lopes RD, Macdougall IC, Obrador GT, Waikar SS, Wanner C, Wheeler DC, Wiecek A, Stankus N, Strutz F, Blackorby A, Cobitz AR, Meadowcroft AM, Paul G, Ranganathan P, Sedani S, Solomon S. Efficacy and Safety of Daprodustat for Treatment of Anemia of Chronic Kidney Disease in Incident Dialysis Patients: A Randomized Clinical Trial. JAMA Intern Med. 2022 Jun 1;182(6):592-602. doi: 10.1001/jamainternmed.2022.0605. |
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IPD for this study will be made available via the Clinical Study Data Request site.
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 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.
A total of 312 participants were randomized in the study.
This was a multicenter study conducted across 14 countries. Participants were randomized to receive either Daprodustat or Darbepoetin alfa.
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| ID | Title | Description |
|---|---|---|
| FG000 | Daprodustat | Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 6, 2017 | Jul 28, 2021 |
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| Darbepoetin alfa | Drug | Darbepoetin alfa will be supplied as prefilled syringes (PFS) for SC/IV injection available in strengths: 20, 30, 40, 60, 80, 100 and 150 mcg. |
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| Iron therapy | Drug | Iron therapy will be administered if ferritin is <=100 ng/mL and/or TSAT is <=20%. |
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| Baseline (Day 1) to Week 52 |
| Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using mixed model repeated measures (MMRM) model. | Baseline (Day 1) and Week 52 |
| Change From Baseline in SBP, DBP, MAP at End of Treatment | SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. End of treatment value for the blood pressure parameters were defined as the latest value on or before the last non-zero dose date plus (+) 1 day. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using ANCOVA model. | Baseline (Day 1) and end of treatment (last on-treatment value until Week 52) |
| Blood Pressure (BP) Exacerbation Events Rate Per 100 Participant Years | BP exacerbation event is defined (based on post-dialysis BP) as SBP >=25 millimeter of mercury (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. | Up to Week 52 |
| Number of Participants With at Least One Blood Pressure Exacerbation Event During Study | BP exacerbation was defined (based on post-dialysis BP) as: SBP >=25 mmHg increased from Baseline or SBP >=180 mmHg; DBP >=15 mmHg increased from Baseline or DBP >=110 mmHg. Number of participants with at least one blood pressure exacerbation event is presented. | Up to Week 52 |
| Change From Baseline in Post-randomization Hgb at Week 52 | Blood samples were collected from participants for Hgb measurements. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1) and Week 52 |
| Number of Hgb Responders (Hgb in the Analysis Range of 10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52) | Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hgb responders were defined as number of participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL. | Weeks 28 to 52 |
| Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis | Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'. | Weeks 28 to 52 |
| Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Superiority Analysis | Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'. | Weeks 28 to 52 |
| Number of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria | Number of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented. | Up to Week 52 |
| Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52 | The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). The PCS is an average score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. PCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1), Weeks 8, 12, 28 and 52 |
| Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 | The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1), Weeks 8, 12, 28 and 52 |
| Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: bodily pain, general health, mental health, role-emotional (role limitations caused by emotional problems), role-physical (role limitations caused by physical problems), social functioning, physical functioning and vitality. Each domain is scored from 0 (poorer health) to 100 (better health). Each domain score ranges from 0 to 100, higher score indicates a better health state and better functioning. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1), Weeks 8, 12, 28 and 52 |
| Change From Baseline in Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52 | The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1), Weeks 28 and 52 |
| Change From Baseline in Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52 | The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1), Weeks 28 and 52 |
| Change From Baseline in Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52 | EQ-5D-5L consists of 2 concepts-EQ-5D-5L descriptive system and EQ Visual Analogue Scale (EQ-VAS). EQ-5D-5L is self-assessment questionnaire, consisting of 5items covering 5 dimensions (mobility,self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale(no problems, slight problems, moderate problems, severe problems and extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state(e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health), higher the score better the health status. Change from Baseline was calculated as post-dose visit value-Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date. | Baseline (Day 1) and Week 52 |
| Change From Baseline in EQ Visual Analogue Scale (EQ-VAS) at Week 52 | The EQ-5D-5L consists of 2 concepts -EQ-5D-5L descriptive system and EQ-VAS. The EQ-5D-5L is a self-assessment questionnaire, consisting of five items covering five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by a five-point Likert scale (no problems, slight problems, moderate problems, severe problems, and extreme problems). The range for the EQ-5D-5L index score is 0 to 1 with '0' is worst health and '1' is full health. The EQ VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst health one can imagine and 100 represents the best health one can imagine. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1) and Week 52 |
| Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | CKD-AQ is 21-item patient reported outcome measure assessing symptoms and symptom impact in participants with anemia associated with CKD. It had 3 domains: 1.Tired/Low Energy/Weak scale consisting of 10 items; 2.Chest Pain/Shortness of Breath scale consisting of 4 items; and 3.Cognitive scale consisting of 3 items. The 4 CKD-AQ single items are: (shortness of breath, no activity), (severity-short breath, resting), (difficulty standing for long time) and (difficulty sleeping). Single-item were recorded based on a 0-100 scoring with 0=worst possible and 100=best possible score. Three domains scores were calculated as average of items in each domain and ranged from 0-100 where 0=worst possible and 100=best possible score. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1) and Week 52 |
| Change From Baseline 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 on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated worse outcome. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1), Weeks 8, 12, 28 and 52 |
| Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic (PK) analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12. Pharmacokinetic Population comprised of participants for whom a pharmacokinetic sample was obtained and analyzed. | Pre-dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12 |
| Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12. | Pre-Dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12 |
| Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12. | Pre-Dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12 |
| Cerritos |
| California |
| 90703 |
| United States |
| GSK Investigational Site | Escondido | California | 92025 | United States |
| GSK Investigational Site | Glendale | California | 91204 | United States |
| GSK Investigational Site | La Palma | California | 90623 | United States |
| GSK Investigational Site | Los Angeles | California | 90022 | United States |
| GSK Investigational Site | Los Angeles | California | 90095 | United States |
| GSK Investigational Site | Lynwood | California | 90262 | United States |
| GSK Investigational Site | Sacramento | California | 95825 | United States |
| GSK Investigational Site | Whittier | California | 90603 | United States |
| GSK Investigational Site | Middlebury | Connecticut | 06762 | United States |
| GSK Investigational Site | Coral Gables | Florida | 33134 | United States |
| GSK Investigational Site | Miami | Florida | 33126 | United States |
| GSK Investigational Site | Miami | Florida | 33169 | United States |
| GSK Investigational Site | Augusta | Georgia | 30912 | United States |
| GSK Investigational Site | Chicago | Illinois | 60637 | United States |
| GSK Investigational Site | Crystal Lake | Illinois | 60014 | United States |
| GSK Investigational Site | Fort Wayne | Indiana | 46804 | United States |
| GSK Investigational Site | Merrillville | Indiana | 46410 | United States |
| GSK Investigational Site | Michigan City | Indiana | 46360 | United States |
| GSK Investigational Site | Iowa City | Iowa | 52242 | United States |
| GSK Investigational Site | Baton Rouge | Louisiana | 70809 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70112 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21287 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39216 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64111 | United States |
| GSK Investigational Site | St Louis | Missouri | 63110 | United States |
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| GSK Investigational Site | Buffalo | New York | 14215 | United States |
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| GSK Investigational Site | New York | New York | 10029 | United States |
| GSK Investigational Site | The Bronx | New York | 10461 | United States |
| GSK Investigational Site | Houston | Texas | 77004 | United States |
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| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Hampton | Virginia | 23666 | United States |
| GSK Investigational Site | Ciudad Evita | Buenos Aires | B1778IFA | Argentina |
| GSK Investigational Site | La Plata | Buenos Aires | B1902COS | Argentina |
| GSK Investigational Site | Morón | Buenos Aires | B1708DPO | Argentina |
| GSK Investigational Site | Pergamino | Buenos Aires | B2700CPM | Argentina |
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| GSK Investigational Site | San Miguel de Tucumán | T4000AHL | Argentina |
| GSK Investigational Site | Adelaide | South Australia | 5000 | Australia |
| GSK Investigational Site | Melbourne | Victoria | 3004 | Australia |
| GSK Investigational Site | St Albans | Victoria | 3021 | Australia |
| GSK Investigational Site | London | Ontario | N6A 5A5 | Canada |
| GSK Investigational Site | Toronto | Ontario | M3M 0B2 | Canada |
| GSK Investigational Site | Greenfield Park | Quebec | J4V 2H1 | Canada |
| GSK Investigational Site | Düsseldorf | North Rhine-Westphalia | 40210 | Germany |
| GSK Investigational Site | Kaiserslautern | Rhineland-Palatinate | 67655 | Germany |
| GSK Investigational Site | Wiesbaden | 65191 | Germany |
| GSK Investigational Site | Bangalore | 560055 | India |
| GSK Investigational Site | Chennai | 600037 | India |
| GSK Investigational Site | Delhi | 110076 | India |
| GSK Investigational Site | Gurgaon | 122001 | India |
| GSK Investigational Site | Kozhikode | 673008 | India |
| GSK Investigational Site | New Delhi | 110060 | India |
| GSK Investigational Site | Pune | 411004 | India |
| GSK Investigational Site | Secunderabad | 560020 | India |
| GSK Investigational Site | Thiruvananthapuram | 695011 | India |
| GSK Investigational Site | Genoa | Liguria | 16132 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20153 | Italy |
| GSK Investigational Site | Pavia | Lombardy | 27100 | Italy |
| GSK Investigational Site | Cagliari | Sardinia | 09100 | Italy |
| GSK Investigational Site | George Town | 10990 | Malaysia |
| GSK Investigational Site | Ipoh | 30450 | Malaysia |
| GSK Investigational Site | Kuala Lumpur | 59100 | Malaysia |
| GSK Investigational Site | Torreón | Coahuila | 27000 | Mexico |
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| GSK Investigational Site | Ciudad de México | State of Mexico | 14000 | Mexico |
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| GSK Investigational Site | Gdansk | 80-952 | Poland |
| GSK Investigational Site | Koło | 62-600 | Poland |
| GSK Investigational Site | Krakow | 31-826 | Poland |
| GSK Investigational Site | Lodz | 92-213 | Poland |
| GSK Investigational Site | Lodz | 96-300 | Poland |
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| GSK Investigational Site | Irkutsk | 664049 | Russia |
| GSK Investigational Site | Mytishchi | 141007 | Russia |
| GSK Investigational Site | Omsk | 644112 | Russia |
| GSK Investigational Site | Saint Petersburg | 191104 | Russia |
| GSK Investigational Site | Saint Petersburg | 194354 | Russia |
| GSK Investigational Site | Saint Petersburg | 196247 | Russia |
| GSK Investigational Site | Saint Petersburg | 197110 | Russia |
| GSK Investigational Site | Smolensk | 214006 | Russia |
| GSK Investigational Site | Volzhskiy | 404120 | Russia |
| GSK Investigational Site | Cape Town | 7925 | South Africa |
| GSK Investigational Site | Anyang-Si, Gyeonggi-do | 14068 | South Korea |
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| GSK Investigational Site | Incheon | 6510 | South Korea |
| GSK Investigational Site | Seoul | 05030 | South Korea |
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| GSK Investigational Site | Badalona | 08916 | Spain |
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| GSK Investigational Site | Birmingham | B9 5SS | United Kingdom |
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| GSK Investigational Site | Middlesbrough | TS4 3BW | United Kingdom |
| Darbepoetin Alfa |
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Daprodustat | Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]). |
| BG001 | Darbepoetin Alfa | Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52) | Blood samples were collected from participants for Hgb measurement. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputations. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. An analysis of covariance (ANCOVA) model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95 percent (%) confidence interval (CI) for the treatment difference (daprodustat-darbepoetin alfa). | Intent-to-Treat (ITT) Population comprised all randomized participants (who received a treatment randomization number). | Posted | Least Squares Mean | Standard Error | Grams per deciliter | Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52) |
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| Secondary | Average Monthly Intravenous Iron Dose (Milligrams) From Baseline to Week 52 | Total IV iron dose per participant was calculated from Day 1 to the earliest of (Week 52 visit date, first blood [red blood cells or whole blood] transfusion date and treatment stop date plus [+] 1 day) which corresponds to the time while the participant was on randomized treatment and before receiving a blood transfusion. Average monthly IV iron dose was calculated by Total IV iron dose divided by (/) (the number of days from Day 1 to the earliest of [Week 52 visit date, first blood transfusion date and treatment stop date +1] /30.4375 days). Data for participants until they underwent a red blood cells or whole blood transfusion was included in the analysis. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | Milligram | Baseline (Day 1) to Week 52 |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using mixed model repeated measures (MMRM) model. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | Millimeter of mercury | Baseline (Day 1) and Week 52 |
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| Secondary | Change From Baseline in SBP, DBP, MAP at End of Treatment | SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. End of treatment value for the blood pressure parameters were defined as the latest value on or before the last non-zero dose date plus (+) 1 day. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using ANCOVA model. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | Millimeter of mercury | Baseline (Day 1) and end of treatment (last on-treatment value until Week 52) |
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| Secondary | Blood Pressure (BP) Exacerbation Events Rate Per 100 Participant Years | BP exacerbation event is defined (based on post-dialysis BP) as SBP >=25 millimeter of mercury (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. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Number | 95% Confidence Interval | Events per 100 participant year | Up to Week 52 |
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| Secondary | Number of Participants With at Least One Blood Pressure Exacerbation Event During Study | BP exacerbation was defined (based on post-dialysis BP) as: SBP >=25 mmHg increased from Baseline or SBP >=180 mmHg; DBP >=15 mmHg increased from Baseline or DBP >=110 mmHg. Number of participants with at least one blood pressure exacerbation event is presented. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Count of Participants | Participants | Up to Week 52 |
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| Secondary | Change From Baseline in Post-randomization Hgb at Week 52 | Blood samples were collected from participants for Hgb measurements. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | Grams per deciliter | Baseline (Day 1) and Week 52 |
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| Secondary | Number of Hgb Responders (Hgb in the Analysis Range of 10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52) | Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hgb responders were defined as number of participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Count of Participants | Participants | Weeks 28 to 52 |
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| Secondary | Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis | Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Median | Full Range | Percentage of days | Weeks 28 to 52 |
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| Secondary | Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Superiority Analysis | Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Median | Full Range | Percentage of days | Weeks 28 to 52 |
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| Secondary | Number of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria | Number of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented. | ITT Population. | Posted | Count of Participants | Participants | Up to Week 52 |
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| Secondary | Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52 | The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). The PCS is an average score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. PCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1), Weeks 8, 12, 28 and 52 |
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| Secondary | Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 | The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1), Weeks 8, 12, 28 and 52 |
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| Secondary | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: bodily pain, general health, mental health, role-emotional (role limitations caused by emotional problems), role-physical (role limitations caused by physical problems), social functioning, physical functioning and vitality. Each domain is scored from 0 (poorer health) to 100 (better health). Each domain score ranges from 0 to 100, higher score indicates a better health state and better functioning. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1), Weeks 8, 12, 28 and 52 |
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| Secondary | Change From Baseline in Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52 | The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1), Weeks 28 and 52 |
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| Secondary | Change From Baseline in Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52 | The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1), Weeks 28 and 52 |
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| Secondary | Change From Baseline in Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52 | EQ-5D-5L consists of 2 concepts-EQ-5D-5L descriptive system and EQ Visual Analogue Scale (EQ-VAS). EQ-5D-5L is self-assessment questionnaire, consisting of 5items covering 5 dimensions (mobility,self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale(no problems, slight problems, moderate problems, severe problems and extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state(e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health), higher the score better the health status. Change from Baseline was calculated as post-dose visit value-Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and Week 52 |
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| Secondary | Change From Baseline in EQ Visual Analogue Scale (EQ-VAS) at Week 52 | The EQ-5D-5L consists of 2 concepts -EQ-5D-5L descriptive system and EQ-VAS. The EQ-5D-5L is a self-assessment questionnaire, consisting of five items covering five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by a five-point Likert scale (no problems, slight problems, moderate problems, severe problems, and extreme problems). The range for the EQ-5D-5L index score is 0 to 1 with '0' is worst health and '1' is full health. The EQ VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst health one can imagine and 100 represents the best health one can imagine. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and Week 52 |
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| Secondary | Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | CKD-AQ is 21-item patient reported outcome measure assessing symptoms and symptom impact in participants with anemia associated with CKD. It had 3 domains: 1.Tired/Low Energy/Weak scale consisting of 10 items; 2.Chest Pain/Shortness of Breath scale consisting of 4 items; and 3.Cognitive scale consisting of 3 items. The 4 CKD-AQ single items are: (shortness of breath, no activity), (severity-short breath, resting), (difficulty standing for long time) and (difficulty sleeping). Single-item were recorded based on a 0-100 scoring with 0=worst possible and 100=best possible score. Three domains scores were calculated as average of items in each domain and ranged from 0-100 where 0=worst possible and 100=best possible score. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and Week 52 |
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| Secondary | Change From Baseline 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 on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated worse outcome. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. | ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1), Weeks 8, 12, 28 and 52 |
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| Secondary | Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic (PK) analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12. Pharmacokinetic Population comprised of participants for whom a pharmacokinetic sample was obtained and analyzed. | Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Blood samples were not collected for PK analysis of daprodustat 12, 16 and 24 mg arms. | Posted | Mean | Standard Deviation | Nanogram per milliliter | Pre-dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12 |
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| Secondary | Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12. | Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed. Blood samples were not collected for PK analysis of daprodustat 12, 16 and 24 mg arms. | Posted | Mean | Standard Deviation | Nanogram per milliliter | Pre-Dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12 |
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| Secondary | Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13) | Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12. | Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed. Blood samples were not collected for PK analysis of daprodustat 12, 16 and 24 mg arms. | Posted | Mean | Standard Deviation | Nanogram per milliliter | Pre-Dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12 |
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All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)
Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Daprodustat | Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]). | 17 | 157 | 52 | 157 | 76 | 157 |
| EG001 | Darbepoetin Alfa | Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL). | 12 | 155 | 51 | 155 | 74 | 155 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Peritonitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Post procedural infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Staphylococcal infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Clostridial sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Device related bacteraemia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Device related sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Escherichia infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Helicobacter gastritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Infected skin ulcer | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Leptospirosis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Staphylococcal bacteraemia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Staphylococcal sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Streptococcal infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Subcutaneous abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Urinary tract infection bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Fluid retention | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Aortic valve incompetence | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypertensive heart disease | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Inadequate haemodialysis | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Open globe injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Peritoneal dialysate leakage | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Peritoneal dialysis complication | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Unintentional medical device removal | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Vascular access malfunction | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bloody peritoneal effluent | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diabetic gastropathy | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertensive encephalopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Uraemic encephalopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Steal syndrome | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA 23.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 23.1 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Thyroid cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Retinopathy hypertensive | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hydrocholecystis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dialysis hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2020 | Jul 23, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000599718 | GSK1278863 |
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| Asian: Central/South Asian Heritage |
|
| Asian: East Asian Heritage |
|
| Asian: South East Asian Heritage |
|
| Black or African American |
|
| White: Arabic/North African Heritage |
|
| White: White/Caucasian/European Heritage |
|
| Mixed race: AI or AN and White |
|
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| Units | Counts |
|---|---|
| Participants |
|
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| Units | Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
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|
|
|
|
| OG001 |
| Darbepoetin Alfa |
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL). |
|
|
|
| Darbepoetin Alfa |
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL). |
|
|
|
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL). |
|
|
|
|
|
|
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).
|
|
|
| OG001 | Darbepoetin Alfa | Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL). |
|
|
|
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL). |
|
|
|
| Darbepoetin Alfa |
Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL). |
|
|
|
|
|
|
| Daprodustat 4 mg |
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks. |
| OG003 | Daprodustat 6 mg | Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks. |
| OG004 | Daprodustat 8 mg | Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks. |
| OG005 | Daprodustat 10 mg | Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks. |
| OG006 | Daprodustat 12 mg | Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks. |
| OG007 | Daprodustat 16 mg | Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks. |
| OG008 | Daprodustat 24 mg | Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks. |
|
|
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
| OG003 | Daprodustat 6 mg | Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks. |
| OG004 | Daprodustat 8 mg | Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks. |
| OG005 | Daprodustat 10 mg | Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks. |
| OG006 | Daprodustat 12 mg | Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks. |
| OG007 | Daprodustat 16 mg | Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks. |
| OG008 | Daprodustat 24 mg | Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks. |
|
|
Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.
| OG003 | Daprodustat 6 mg | Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks. |
| OG004 | Daprodustat 8 mg | Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks. |
| OG005 | Daprodustat 10 mg | Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks. |
| OG006 | Daprodustat 12 mg | Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks. |
| OG007 | Daprodustat 16 mg | Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks. |
| OG008 | Daprodustat 24 mg | Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks. |
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