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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004372-56 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daprodustat | Experimental | 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. |
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| Epoetin alfa | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daprodustat tablets | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 | Mesa | Arizona | 85210 | 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. | |
| 35918106 | Derived | Coyne DW, Singh AK, Lopes RD, Bailey CK, DiMino TL, Huang C, Connaire J, Rastogi A, Kim SG, Orias M, Shah S, Patel V, Cobitz AR, Wanner C. Three Times Weekly Dosing of Daprodustat versus Conventional Epoetin for Treatment of Anemia in Hemodialysis Patients: ASCEND-TD: A Phase 3 Randomized, Double-Blind, Noninferiority Trial. Clin J Am Soc Nephrol. 2022 Sep;17(9):1325-1336. doi: 10.2215/CJN.00550122. Epub 2022 Aug 2. |
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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 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 595 participants were screened, of which 188 were screen failures. A total of 407 participants were enrolled in the study.
This was a multicenter study conducted at 90 centers in 13 countries. Participants were randomized to receive either Daprodustat or Epoetin alfa.
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| ID | Title | Description |
|---|---|---|
| FG000 | Daprodustat | Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter [g/dL]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose. |
| 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 | Nov 15, 2017 | Jun 17, 2021 |
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Subjects will be randomized to receive either daprodustat or epoetin alfa in a parallel manner. .
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This is a double-blind study, in which the subject, investigator, site staff and the sponsor will remain blinded to each subjects study treatment assignment throughout the course of the study, with the exception of a limited number of unblinded site staff who are necessary to maintain the blind, as well as a limited number of sponsor staff.
| Matching placebo tablets | Drug | 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. |
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| Epoetin alfa vials | Drug | Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route. |
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| Saline vials or bags | Drug | 0.9% sodium chloride saline vials or bags administered by the IV route. |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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 |
| Fresno |
| California |
| 93720 |
| United States |
| GSK Investigational Site | Los Angeles | California | 90025 | United States |
| GSK Investigational Site | Paramount | California | 90723 | United States |
| GSK Investigational Site | Middlebury | Connecticut | 06762 | United States |
| GSK Investigational Site | Hollywood | Florida | 33024 | United States |
| GSK Investigational Site | Miami | Florida | 33169 | United States |
| GSK Investigational Site | Tampa | Florida | 33614 | United States |
| GSK Investigational Site | Macon | Georgia | 31201 | United States |
| GSK Investigational Site | Meridian | Idaho | 83642 | United States |
| GSK Investigational Site | Pittsfield | Massachusetts | 01201 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64111 | United States |
| GSK Investigational Site | St Louis | Missouri | 63110 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87109 | United States |
| GSK Investigational Site | College Point | New York | 11356 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73116 | United States |
| GSK Investigational Site | Houston | Texas | 77004 | United States |
| GSK Investigational Site | Houston | Texas | 77099 | United States |
| GSK Investigational Site | Lufkin | Texas | 75904 | United States |
| GSK Investigational Site | Alexandria | Virginia | 22304 | United States |
| GSK Investigational Site | Hampton | Virginia | 23666 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23510 | United States |
| GSK Investigational Site | Mar del Plata | Buenos Aires | 7600 | Argentina |
| GSK Investigational Site | Pergamino | Buenos Aires | B2700CPM | Argentina |
| GSK Investigational Site | Sarandí | Buenos Aires | B1872EEB | Argentina |
| GSK Investigational Site | Rosario | Santa Fe Province | 2000 | Argentina |
| GSK Investigational Site | Heidelberg | Victoria | 3084 | Australia |
| GSK Investigational Site | Parkville | Victoria | 3050 | Australia |
| GSK Investigational Site | Salvador | Estado de Bahia | 40415-065 | Brazil |
| GSK Investigational Site | Curitiba | Paraná | 80440-020 | Brazil |
| GSK Investigational Site | Passo Fundo | Rio Grande do Sul | 99010-080 | Brazil |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| GSK Investigational Site | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| GSK Investigational Site | Belo Horizonte, Minas Gerais | 30150-221 | Brazil |
| GSK Investigational Site | São Paulo | 04039-000 | Brazil |
| GSK Investigational Site | Oshawa | Ontario | L1G 2B9 | Canada |
| GSK Investigational Site | Bayonne | 64109 | France |
| GSK Investigational Site | Epagny Metz-Tessy | 74370 | France |
| GSK Investigational Site | Le Mans | 72037 | France |
| GSK Investigational Site | Nice | 06001 | France |
| GSK Investigational Site | Strasbourg | 67000 | France |
| GSK Investigational Site | Bologna | Emilia-Romagna | 40138 | Italy |
| GSK Investigational Site | Modena | Emilia-Romagna | 41124 | Italy |
| GSK Investigational Site | Pavia | Lombardy | 27100 | Italy |
| GSK Investigational Site | Verona | Veneto | 37126 | Italy |
| GSK Investigational Site | Katowice | 40-027 | Poland |
| GSK Investigational Site | Lodz | 92-213 | Poland |
| GSK Investigational Site | Sandomierz | 27-600 | Poland |
| GSK Investigational Site | Tarnowskie Góry | 42-612 | Poland |
| GSK Investigational Site | Żyrardów | 96-300 | Poland |
| GSK Investigational Site | Constanța | 900591 | Romania |
| GSK Investigational Site | Reşiţa | 320166 | Romania |
| GSK Investigational Site | Kazan' | 420012 | Russia |
| GSK Investigational Site | Kolomna | 140407 | Russia |
| GSK Investigational Site | Krasnodar | 350029 | Russia |
| GSK Investigational Site | Krasnogorsk | 143400 | Russia |
| GSK Investigational Site | Mytischi | 141009 | Russia |
| GSK Investigational Site | Novorossiysk | 353915 | Russia |
| GSK Investigational Site | Novosibirsk | 630087 | Russia |
| GSK Investigational Site | Omsk | 644111 | Russia |
| GSK Investigational Site | Orenburg | 460040 | Russia |
| GSK Investigational Site | Penza | 440034 | Russia |
| GSK Investigational Site | Podolsk | 142110 | Russia |
| GSK Investigational Site | Saint Petersburg | 193318 | Russia |
| GSK Investigational Site | Saint Petersburg | 194104 | 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 | Saint Petersburg | 197374 | Russia |
| GSK Investigational Site | Ufa | 450071 | Russia |
| GSK Investigational Site | Yaroslavl | 150062 | Russia |
| GSK Investigational Site | Anyang-Si, Gyeonggi-do | 14068 | South Korea |
| GSK Investigational Site | Busan | 49201 | South Korea |
| GSK Investigational Site | Goyang-si, Gyeonggi-do | 10326 | South Korea |
| GSK Investigational Site | Incheon | 405-760 | South Korea |
| GSK Investigational Site | Seoul | 07061 | South Korea |
| GSK Investigational Site | Seoul | 07441 | South Korea |
| GSK Investigational Site | Seoul | 134-727 | South Korea |
| GSK Investigational Site | Almería | 04009 | Spain |
| GSK Investigational Site | Badalona | 08916 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Girona | 17007 | Spain |
| GSK Investigational Site | Granollers, Barcelona | 08041 | Spain |
| GSK Investigational Site | Madrid | 28100 | Spain |
| GSK Investigational Site | Manises (Valencia) | 46940 | Spain |
| GSK Investigational Site | Sanlúcar de Barrameda (Cádiz) | 11540 | Spain |
| GSK Investigational Site | Bradford | BD5 0NA | United Kingdom |
| GSK Investigational Site | London | SE5 9RS | United Kingdom |
| GSK Investigational Site | Sheffield | S5 7AU | United Kingdom |
| GSK Investigational Site | Swansea | SA6 6NL | United Kingdom |
| FG001 | Epoetin Alfa | Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Daprodustat | Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter [g/dL]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose. |
| BG001 | Epoetin Alfa | Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose. |
| 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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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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 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. | All Randomized (Intent-to-treat [ITT]) Population comprised of all randomized participants. Any participant who received a treatment randomization number was considered to have been randomized. | Posted | Least Squares Mean | Standard Error | Grams per deciliter (g/dL) | Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52) |
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| Secondary | 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. | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Milligrams | Day 1 to Week 52 |
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| Secondary | 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. | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Grams per deciliter | Baseline (Pre-dose on Day 1) and Week 52 |
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| Secondary | 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. | All Randomized (ITT) Population. Only those participants with at least one evaluable hemoglobin value during the evaluation period were analyzed. | Posted | Median | Inter-Quartile Range | Percentage of days | Week 28 to Week 52 |
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| Secondary | 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. | All Randomized (ITT) Population. Only those participants with at least one evaluable hemoglobin value during the evaluation period were analyzed. | Posted | Count of Participants | Participants | Week 28 to Week 52 |
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| Secondary | 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. | All Randomized (ITT) Population | Posted | Number | Percentage of participants | Up to Week 52 |
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| Secondary | 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. | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Millimeter of mercury (mmHg) | Baseline (Week -4 ) and Week 52 |
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| Secondary | 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. | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Posted | Mean | Standard Error | Millimeter of mercury (mmHg) | Baseline (Week -4) and end of treatment (last on-treatment value until Week 52) |
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| Secondary | 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. | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Posted | Number | 95% Confidence Interval | Events per 100 participant years | Up to 52 weeks |
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| Secondary | 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. | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Posted | Count of Participants | Participants | Up to 52 weeks |
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| Secondary | 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. | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed (represented as n=X in the category titles). | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Pre-dose on Day 1) and Weeks 8, 12, 28, 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Pharmacokinetic Population comprised of all randomized participants for whom a post-Baseline pharmacokinetic sample was obtained and analyzed. Only those participants with data available at specified time points were analyzed (represented as n=X in the category titles). | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed (represented as n=X in the category titles). | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | 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 |
|
Treatment emergent serious adverse events (SAEs) and non-serious adverse events (non-serious AEs) were collected up to 52 weeks.
Safety Population was used to assess SAEs and non-serious AEs, which comprised of all randomized participants who have taken at least 1 dose of study treatment. One participant from Randomized (ITT) Population (N=407) did not receive study treatment, hence was not included in Safety Population (N=406).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daprodustat | Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter [g/dL]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose. | 18 | 270 | 80 | 270 | 74 | 270 |
| EG001 | Epoetin Alfa | Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose. | 10 | 136 | 47 | 136 | 42 | 136 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Arteriovenous fistula site infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Acinetobacter infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Campylobacter colitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Injection site cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Prostatitis Escherichia coli | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Proteus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Tubo-ovarian abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Arteriovenous fistula occlusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Arteriovenous fistula site haematoma | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Arteriovenous graft site stenosis | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Vascular access malfunction | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Vascular access site thrombosis | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Vascular access site pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arterial occlusive disease | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Brachiocephalic vein stenosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dialysis induced hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Malignant hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diabetic hyperglycaemic coma | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertensive encephalopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diabetic gastroparesis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastric antral vascular ectasia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastric dilatation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatitis relapsing | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Normocytic anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site inflammation | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Device related thrombosis | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neuropathic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lip and/or oral cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Oropharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Smooth muscle cell neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Calculus urethral | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Congenital cystic kidney disease | Congenital, familial and genetic disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombosis in device | Product Issues | MedDRA 23.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | 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 | Sep 2, 2020 | Jun 17, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000599718 | GSK1278863 |
Not provided
Not provided
Not provided
| Male |
|
| AMERICAN INDIAN OR ALASKAN NATIVE |
|
| ASIAN - CENTRAL/SOUTH ASIAN HERITAGE |
|
| ASIAN - EAST ASIAN HERITAGE |
|
| ASIAN - SOUTH EAST ASIAN HERITAGE |
|
| NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER |
|
| WHITE - ARABIC/NORTH AFRICAN HERITAGE |
|
| WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE |
|
| MIXED WHITE RACE |
|
| MIXED RACE |
|
| UNKNOWN |
|
|
|
|
| Epoetin Alfa |
Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose. |
|
|
|
|
|
|
|
|
|
|
|
|
| Epoetin Alfa |
Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose. |
|
|
|
| Epoetin Alfa |
Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose. |
|
|
|
|
|
|
|
|
| OG001 | Epoetin Alfa | Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose. |
|
|
|
Participants received daprodustat tablets 8 mg orally three-times weekly at the time of the pharmacokinetic visit.
| OG003 | Daprodustat 12 mg | Participants received daprodustat tablets 12 mg orally three-times weekly at the time of the pharmacokinetic visit. |
| OG004 | Daprodustat 16 mg | Participants received daprodustat tablets 16 mg orally three-times weekly at the time of the pharmacokinetic visit. |
| OG005 | Daprodustat 20 mg | Participants received daprodustat tablets 20 mg orally three-times weekly at the time of the pharmacokinetic visit. |
| OG006 | Daprodustat 24 mg | Participants received daprodustat tablets 24 mg orally three-times weekly at the time of the pharmacokinetic visit. |
| OG007 | Daprodustat 32 mg | Participants received daprodustat tablets 32 mg orally three-times weekly at the time of the pharmacokinetic visit. |
| OG008 | Daprodustat 48 mg | Participants received daprodustat tablets 48 mg orally three-times weekly at the time of the pharmacokinetic visit. |
|
|
| OG003 | Daprodustat 12 mg | Participants received daprodustat tablets 12 mg orally three-times weekly at the time of the pharmacokinetic visit. |
| OG004 | Daprodustat 16 mg | Participants received daprodustat tablets 16 mg orally three-times weekly at the time of the pharmacokinetic visit. |
| OG005 | Daprodustat 20 mg | Participants received daprodustat tablets 20 mg orally three-times weekly at the time of the pharmacokinetic visit. |
| OG006 | Daprodustat 24 mg | Participants received daprodustat tablets 24 mg orally three-times weekly at the time of the pharmacokinetic visit. |
| OG007 | Daprodustat 32 mg | Participants received daprodustat tablets 32 mg orally three-times weekly at the time of the pharmacokinetic visit. |
| OG008 | Daprodustat 48 mg | Participants received daprodustat tablets 48 mg orally three-times weekly at the time of the pharmacokinetic visit. |
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