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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002270-39 | EudraCT Number |
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The purpose of this multi-center study in non-dialysis participants with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daprodustat receivers | Experimental | Participants will receive oral daprodustat once daily |
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| Placebo receivers | Placebo Comparator | Participants will receive oral placebo once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daprodustat (GSK1278863) | Drug | Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Hemoglobin From Baseline and Over the Evaluation Period (Mean Over Week 24 and 28) | Blood samples were collected at given time points from participants for hemoglobin measurements. Evaluation period hemoglobin value was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 24 to Week 28 inclusive). For the primary analysis, the missing post-Baseline hemoglobin 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 value was the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using the Analysis of Covariance (ANCOVA) model with terms for treatment, Baseline hemoglobin, and region. | Baseline (Day 1) and Week 24 to Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hemoglobin Increase of >=1.0 Grams Per Deciliter From Baseline to Evaluation Period | Blood samples were collected at given time points for hemoglobin measurements. Evaluation period hemoglobin value was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 24 to Week 28 inclusive). 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. Percentage of participants with hemoglobin increase of >=1.0 grams per deciliter from Baseline to evaluation period was analyzed using Cochran-Mantel-Haenszel (CMH) chi-squared test. The percentage values presented has been rounded off. |
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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 | Homewood | Alabama | 35209 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36868377 | Background | Johansen KL, Cobitz AR, Singh AK, Macdougall IC, Lopes RD, Obrador GT, Kovesdy CP, Israni R, Jha V, Okoro T, Sprys M, Jolly S, Lindsay AC, Bhatt P, Camejo RR, Keeley T, Cizman B, Wheeler DC. The ASCEND-NHQ randomized trial found positive effects of daprodustat on hemoglobin and quality of life in patients with non-dialysis chronic kidney disease. Kidney Int. 2023 Jun;103(6):1180-1192. doi: 10.1016/j.kint.2023.02.019. Epub 2023 Mar 2. | |
| 36005278 |
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Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
A total of 1336 participants were screened, of which 722 were screen failures. A total of 614 participants were enrolled in the study.
This was a multicenter study conducted at 142 centers in 14 countries. Participants were randomized to receive either Daprodustat or Placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matching placebo once daily orally for up to 28 weeks followed by 4 weeks of follow-up. |
| FG001 | Daprodustat | Participants received daprodustat tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 milligrams (mg) once daily orally for up to 28 weeks, followed by 4 weeks of follow-up. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (11 to 12 grams per deciliter [g/dL]) |
| 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 | Aug 23, 2019 | Sep 7, 2021 |
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Participants will be randomized to receive Daprodustat or placebo in a randomized manner.
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This will be a double-blind study. The participant, investigator, site staff, and study team will be blinded to the assigned study treatment.
| Placebo | Drug | Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food. |
|
| Iron therapy | Drug | Iron therapy will be administered if ferritin is <50 Nano gram per milliliter and/or TSAT is <15 percent. |
|
| Baseline (Day 1) and Week 24 to Week 28 |
| Change From Baseline in Short Form-36 (SF-36) Questionnaire Vitality Domain Score by Traditional Scoring at Week 28 | 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 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 Perception of Health.Each domain is scored from 0 (poorer health) to 100 (better health). Vitality domain score ranges from 0-100; higher score indicates a better health state & better functioning. Change from Baseline was calculated as Post-Dose Visit Value at Week 28 minus Baseline. For primary analysis, the missing on-treatment Week 28 SF-36 Vitality domain scores were imputed using pre-specified multiple imputations. Baseline value was latest non-missing pre-dose assessment on or before randomization date. Analysis was performed using ANCOVA model with terms for treatment, Baseline score, and region. | Baseline (Day 1) and Week 28 |
| Percentage of Participants With Hgb Response (Hgb in the 11-12 Grams/Deciliter Range) During Evaluation Period (Week 24 to Week 28 Inclusive) | Mean hemoglobin during the evaluation period was defined as the mean of all evaluable hemoglobin values during the evaluation period (Week 24 to Week 28 inclusive) including any evaluable unscheduled hemoglobin values that were taken during this period. Percentage of participants with Hgb response was defined as participants with mean Hgb within range (11-12 grams per deciliter during the evaluation period (Week 24 to Week 28 inclusive) and it was analyzed using Cochran-Mantel-Haenszel (CMH) chi-squared test. The percentage values presented has been rounded off. | Week 24 to Week 28 |
| Percentage of Time With Hgb Within the Target Range (11-12 Grams Per Deciliter) During Evaluation Period (Week 24 to Week 28 Inclusive) (Hodges-Lehmann Estimate) | Percentage of days for which participant's Hgb was within the target range of 11-12 grams per deciliter during the evaluation period (Week 24 to Week 28 inclusive), including any unscheduled evaluable Hgb values that were taken during this time period. Percentage of time for which Hgb was within the target range (11-12 grams per deciliter) for a participant was calculated by dividing 'the total number of days that Hgb was within range during Week 24 to 28' by 'the total number of days the participant remained on treatment during Week 24 to 28'. | Week 24 to Week 28 |
| Percentage of Time With Hgb Within the Target Range (11-12 Grams Per Deciliter) During Evaluation Period (Week 24 to Week 28 Inclusive) (Mann-Whitney Estimate) | Percentage of days for which participant's Hgb was within the target range of 11-12 grams per deciliter during the evaluation period (Week 24 to Week 28 inclusive), including any unscheduled evaluable Hgb values that were taken during this time period. Percentage of time for which Hgb was within the target range (11-12 grams per deciliter) for a participant was calculated by dividing 'the total number of days that Hgb was within range during Week 24 to 28' by 'the total number of days the participant remained on treatment during Week 24 to 28' | Week 24 to Week 28 |
| Change From Baseline in Post-randomization Hgb at Week 28 | Blood samples were collected at given time points for hemoglobin measurements. Change from Baseline in Hgb was analyzed using a mixed model repeated measures (MMRM) approach. Change from Baseline was calculated as Post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1) and Week 28 |
| Rate of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria | The incidence rate of participants permanently stopping randomized treatment due to meeting rescue criteria is presented. | Up to Week 28 |
| Change From Baseline by Domain and Single Item Scores on the Chronic Kidney Disease -Anemia Questionnaire (CKD-AQ) Symptom Questionnaire | CKD-AQ is 21-item patient reported outcomes measure assessing symptoms & symptom impact in participants with anemia associated with CKD.CKD-AQ identified 3 domains:1.Tired/Low Energy/Weak scale consisting of ten items;2.Chest Pain/Shortness of Breath scale consisting of four items and 3.Cognitive scale consisting of three items;Single items included: 4.Difficulty Sleeping;5.Difficulty Standing for long periods of time;6.Severity-Shortness of breath while sitting/resting;7.Time with Shortness of breath while not doing activity.Single-item measures were recorded based on 0-100 scoring with 0 is worst possible & 100 is best possible score.Total domain score is calculated as average of items in each domain & ranged from 0-100 where 0 is worst possible and 100 is best possible score.Change from Baseline was calculated as post-dose visit value minus Baseline.Baseline was latest non-missing pre-dose assessment on or before randomization date. Adjusted mean & standard error is presented. | Baseline (Day 1) and Week 28 |
| 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 value was the latest non-missing pre-dose assessment on or before the randomization date. Adjusted mean and standard error is presented. | Baseline (Day 1) and Week 28 |
| Change From Baseline in the SF-36 Physical Functioning Domain | 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 eight 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 perception of health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning domain score ranges from 0-100; higher score indicates a better health state and better functioning. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1) and Week 28 |
| Change From Baseline of the SF-36 Individual Items in the Vitality Domain | 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 eight 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 perception of health. Individual vitality items include: 1. Did you feel full of life?, 2. Did you have a lot of energy?, 3. Did you feel worn out?, 4. Did you feel tired?. Score of each item in the vitality domain ranges from 0-100; higher score indicates better health state and better functioning. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1) and Week 28 |
| Number of Participants Currently Employed as Per Work Productivity and Activity Impairment Questionnaire: Anemic Symptoms Clinical Practice Version (WPAI-ANS-CPV) | WPAI-ANS-CPV is anemia specific questionnaire designed as self-reported quantitative assessment of social functioning related to work and regular daily activities. It contains 2 concepts-work productivity impairment measured via absenteeism(time missed from work), presenteeism(impairment at work) and regular daily activity impairment. WPAI questions (Q) were:1) currently employed,2) work time missed due to problem, 3) impairment while working due to problem, 4) overall work impairment due to problem, 5) activity impairment due to problem. WPAI generates 4 domain scores:percent (%) of work time missed(absenteeism),% of impairment while working(presenteeism),% of overall work impairment(absenteeism and presenteeism combined),% of activity impairment. Number of participants currently employed as per WPAI-ANS-CPV is presented. | Week 8, Week 12 and Week 28 |
| Change From Baseline in WPAI-ANS-CPV: Percent Time Missed From Work | WPAI-ANS-CPV is anemia specific questionnaire designed as self-reported quantitative assessment of social functioning related to work and regular daily activities. It contains 2 concepts-work productivity impairment measured via absenteeism (time missed from work), presenteeism (impairment at work) and regular daily activity impairment. WPAI questions (Q) were: 1) currently employed, 2) work time missed due to problem, 3) impairment while working due to problem, 4)overall work impairment due to problem, 5) activity impairment due to problem. Percent work time missed due to problem was a subscale and calculated as: Q2/(Q2+Q4) for those who were currently employed. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment and less productivity. Change from Baseline was calculated as post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1), Week 8, Week 12 and Week 28 |
| Change From Baseline in WPAI-ANS-CPV: Mean Hours Missed From Work in the Past 7 Days | WPAI-ANS-CPV is anemia specific questionnaire designed as self-reported quantitative assessment of social functioning related to work and regular daily activities. It contains 2 concepts-work productivity impairment measured via absenteeism (time missed from work), presenteeism (impairment at work) and regular daily activity impairment. WPAI Qs were: 1) currently employed, 2) work time missed due to problem, 3) impairment while working due to problem, 4) overall work impairment due to problem, 5) activity impairment due to problem. Change from Baseline was calculated as post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1), Week 8, Week 12 and Week 28 |
| Change From Baseline in WPAI: Percent Impairment at Work | WPAI-ANS-CPV is anemia specific questionnaire designed as self-reported quantitative assessment of social functioning related to work and regular daily activities.It contains 2 concepts-work productivity impairment measured via absenteeism(time missed from work),presenteeism(impairment at work) and regular daily activity impairment.WPAI Qs were:1)currently employed,2)work time missed due to problem,3)impairment while working due to problem,4)overall work impairment due to problem,5)activity impairment due to problem. % Impairment while Working due to Problem was subscale and calculated as: Q5/10 for those who were currently employed and actually worked in past 7 days. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment and less productivity. Change from Baseline was calculated as post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before randomization date. | Baseline (Day 1), Week 8, Week 12 and Week 28 |
| Change From Baseline in WPAI: Percent Overall Work Impairment | WPAI-ANS-CPV is anemia specific questionnaire designed as self-reported quantitative assessment of social functioning related to work and regular daily activities. It contains 2 concepts-work productivity impairment measured via absenteeism (time missed from work), presenteeism (impairment at work) and regular daily activity impairment. WPAI Qs were: 1) currently employed, 2) work time missed due to problem, 3) impairment while working due to problem, 4) overall work impairment due to problem, 5) activity impairment due to problem. Percent overall work impairment due to problem was a subscale and calculated as: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))×(Q5/10)] for those who were currently employed. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment. Change from Baseline was calculated as post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before randomization date. | Baseline (Day 1), Week 8, Week 12 and Week 28 |
| Change From Baseline in WPAI: Percent Regular Daily Activity Impairment | WPAI-ANS-CPV is anemia specific questionnaire designed as self-reported quantitative assessment of social functioning related to work and regular daily activities.It contains 2 concepts-work productivity impairment measured via absenteeism (time missed from work), presenteeism (impairment at work) and regular daily activity impairment. WPAI Qs were: 1) currently employed, 2) work time missed due to problem, 3) impairment while working due to problem, 4) overall work impairment due to problem, 5) activity impairment due to problem. Percent activity impairment due to problem was a subscale and calculated as: Q5/10 for all respondents. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment. Change from Baseline was calculated as post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before randomization date. | Baseline (Day 1), Week 8, Week 12 and Week 28 |
| Change From Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) Utility Score | The EQ-5D-5L is a self-assessment questionnaire, consisting of 5 items covering 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension is measured by a 5-point Likert scale (1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems). The responses for the five dimension together form a five-figure description of health state. Each of these five-figure health states have attached valuation (utility score), expressed as single index on a scale from 0-1, where 1 is full health and 0 is worst health. The higher the score the better the health status. Change from Baseline was calculated as post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1) and Week 28 |
| Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score | The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 'the best health you can imagine' and 'the worst health you can imagine' at the time of completion. It is a self-assessment visual analogue scale, ranging from 0=worst imaginable to 100=best. Change from Baseline was calculated as post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1) and Week 28 |
| Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) at Week 28 | SBP, DBP and MAP were measured with participants in a seated position after at least a 5-minute of rest. MAP is the average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. | Baseline (Day 1) and Week 28 |
| Percentage of Participants With at Least One Blood Pressure (BP) Exacerbation Event | Percentage of participants with at least one BP event is presented. BP exacerbation is defined as: SBP exacerbation: SBP >= 25 mmHg increase from Baseline or SBP >= 180 mmHg; DBP exacerbation: DBP >= 15 mmHg increase from Baseline or DBP >= 110 mmHg. Percentage of participants with at least one BP event is presented. The percentage values presented has been rounded off. | Up to Week 28 |
| Little Rock |
| Arkansas |
| 72204 |
| United States |
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| GSK Investigational Site | Ryazan | 390037 | Russia |
| GSK Investigational Site | Saint Petersburg | 194355 | Russia |
| GSK Investigational Site | Saint Petersburg | 197022 | Russia |
| GSK Investigational Site | Stavropol | 355017 | Russia |
| GSK Investigational Site | Yaroslavl | 150000 | Russia |
| GSK Investigational Site | Yaroslavl | 150030 | Russia |
| GSK Investigational Site | Yaroslavl | 150062 | Russia |
| GSK Investigational Site | Busan | 49201 | South Korea |
| GSK Investigational Site | Busan | 49241 | South Korea |
| GSK Investigational Site | Daegu | 42415 | South Korea |
| GSK Investigational Site | Daegu | 42601 | South Korea |
| GSK Investigational Site | Gyeonggi-do | 463-712 | South Korea |
| GSK Investigational Site | Seongnam-si, Gyeonggi-do | 13620 | South Korea |
| GSK Investigational Site | Seoul | 03312 | South Korea |
| GSK Investigational Site | Seoul | 08308 | South Korea |
| GSK Investigational Site | Badalona | 08916 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15890 | Spain |
| GSK Investigational Site | Canterbury | Kent | CT1 3NG | United Kingdom |
| GSK Investigational Site | Derby | DE22 3NE | United Kingdom |
| GSK Investigational Site | London | SE5 9RS | United Kingdom |
| GSK Investigational Site | Peterborough | PE3 9GZ | United Kingdom |
| GSK Investigational Site | Plymouth | PL6 8DH | United Kingdom |
| GSK Investigational Site | Shrewsbury | SY3 8XQ | United Kingdom |
| GSK Investigational Site | Swansea | SA6 6NL | United Kingdom |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matching placebo once daily orally for up to 28 weeks followed by 4 weeks of follow-up. |
| BG001 | Daprodustat | Participants received daprodustat tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 milligrams (mg) once daily orally for up to 28 weeks, followed by 4 weeks of follow-up. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (11 to 12 grams per deciliter [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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 in Hemoglobin From Baseline and Over the Evaluation Period (Mean Over Week 24 and 28) | Blood samples were collected at given time points from participants for hemoglobin measurements. Evaluation period hemoglobin value was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 24 to Week 28 inclusive). For the primary analysis, the missing post-Baseline hemoglobin 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 value was the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using the Analysis of Covariance (ANCOVA) model with terms for treatment, Baseline hemoglobin, and region. | Intent-to-Treat (ITT) Population comprised all randomized participants regardless of whether they took study drug. | Posted | Least Squares Mean | Standard Error | Grams per deciliter | Baseline (Day 1) and Week 24 to Week 28 |
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| Secondary | Percentage of Participants With Hemoglobin Increase of >=1.0 Grams Per Deciliter From Baseline to Evaluation Period | Blood samples were collected at given time points for hemoglobin measurements. Evaluation period hemoglobin value was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 24 to Week 28 inclusive). 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. Percentage of participants with hemoglobin increase of >=1.0 grams per deciliter from Baseline to evaluation period was analyzed using Cochran-Mantel-Haenszel (CMH) chi-squared test. The percentage values presented has been rounded off. | Intent-to-Treat population. | Posted | Number | Percentage of participants | Baseline (Day 1) and Week 24 to Week 28 |
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| Secondary | Change From Baseline in Short Form-36 (SF-36) Questionnaire Vitality Domain Score by Traditional Scoring at Week 28 | 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 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 Perception of Health.Each domain is scored from 0 (poorer health) to 100 (better health). Vitality domain score ranges from 0-100; higher score indicates a better health state & better functioning. Change from Baseline was calculated as Post-Dose Visit Value at Week 28 minus Baseline. For primary analysis, the missing on-treatment Week 28 SF-36 Vitality domain scores were imputed using pre-specified multiple imputations. Baseline value was latest non-missing pre-dose assessment on or before randomization date. Analysis was performed using ANCOVA model with terms for treatment, Baseline score, and region. | Intent-to-Treat Population. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and Week 28 |
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| Secondary | Percentage of Participants With Hgb Response (Hgb in the 11-12 Grams/Deciliter Range) During Evaluation Period (Week 24 to Week 28 Inclusive) | Mean hemoglobin during the evaluation period was defined as the mean of all evaluable hemoglobin values during the evaluation period (Week 24 to Week 28 inclusive) including any evaluable unscheduled hemoglobin values that were taken during this period. Percentage of participants with Hgb response was defined as participants with mean Hgb within range (11-12 grams per deciliter during the evaluation period (Week 24 to Week 28 inclusive) and it was analyzed using Cochran-Mantel-Haenszel (CMH) chi-squared test. The percentage values presented has been rounded off. | Intent-to-Treat Population. | Posted | Number | Percentage of participants | Week 24 to Week 28 |
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| Secondary | Percentage of Time With Hgb Within the Target Range (11-12 Grams Per Deciliter) During Evaluation Period (Week 24 to Week 28 Inclusive) (Hodges-Lehmann Estimate) | Percentage of days for which participant's Hgb was within the target range of 11-12 grams per deciliter during the evaluation period (Week 24 to Week 28 inclusive), including any unscheduled evaluable Hgb values that were taken during this time period. Percentage of time for which Hgb was within the target range (11-12 grams per deciliter) for a participant was calculated by dividing 'the total number of days that Hgb was within range during Week 24 to 28' by 'the total number of days the participant remained on treatment during Week 24 to 28'. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Median | Full Range | Percentage of days | Week 24 to Week 28 |
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| Secondary | Percentage of Time With Hgb Within the Target Range (11-12 Grams Per Deciliter) During Evaluation Period (Week 24 to Week 28 Inclusive) (Mann-Whitney Estimate) | Percentage of days for which participant's Hgb was within the target range of 11-12 grams per deciliter during the evaluation period (Week 24 to Week 28 inclusive), including any unscheduled evaluable Hgb values that were taken during this time period. Percentage of time for which Hgb was within the target range (11-12 grams per deciliter) for a participant was calculated by dividing 'the total number of days that Hgb was within range during Week 24 to 28' by 'the total number of days the participant remained on treatment during Week 24 to 28' | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Median | Full Range | Percentage of days | Week 24 to Week 28 |
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| Secondary | Change From Baseline in Post-randomization Hgb at Week 28 | Blood samples were collected at given time points for hemoglobin measurements. Change from Baseline in Hgb was analyzed using a mixed model repeated measures (MMRM) approach. Change from Baseline was calculated as Post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. | Intent-to-Treat 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 28 |
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| Secondary | Rate of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria | The incidence rate of participants permanently stopping randomized treatment due to meeting rescue criteria is presented. | Intent-to-Treat Population. | Posted | Number | 95% Confidence Interval | Events per 100 person year | Up to Week 28 |
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| Secondary | Change From Baseline by Domain and Single Item Scores on the Chronic Kidney Disease -Anemia Questionnaire (CKD-AQ) Symptom Questionnaire | CKD-AQ is 21-item patient reported outcomes measure assessing symptoms & symptom impact in participants with anemia associated with CKD.CKD-AQ identified 3 domains:1.Tired/Low Energy/Weak scale consisting of ten items;2.Chest Pain/Shortness of Breath scale consisting of four items and 3.Cognitive scale consisting of three items;Single items included: 4.Difficulty Sleeping;5.Difficulty Standing for long periods of time;6.Severity-Shortness of breath while sitting/resting;7.Time with Shortness of breath while not doing activity.Single-item measures were recorded based on 0-100 scoring with 0 is worst possible & 100 is best possible score.Total domain score is calculated as average of items in each domain & ranged from 0-100 where 0 is worst possible and 100 is best possible score.Change from Baseline was calculated as post-dose visit value minus Baseline.Baseline was latest non-missing pre-dose assessment on or before randomization date. Adjusted mean & standard error is presented. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Mean | Standard Error | Scores on a scale | Baseline (Day 1) and Week 28 |
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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 value was the latest non-missing pre-dose assessment on or before the randomization date. Adjusted mean and standard error is presented. | Intent-to-Treat 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 28 |
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| Secondary | Change From Baseline in the SF-36 Physical Functioning Domain | 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 eight 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 perception of health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning domain score ranges from 0-100; higher score indicates a better health state and better functioning. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. | Intent-to-Treat 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 28 |
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| Secondary | Change From Baseline of the SF-36 Individual Items in the Vitality Domain | 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 eight 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 perception of health. Individual vitality items include: 1. Did you feel full of life?, 2. Did you have a lot of energy?, 3. Did you feel worn out?, 4. Did you feel tired?. Score of each item in the vitality domain ranges from 0-100; higher score indicates better health state and better functioning. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. | Intent-to-Treat 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 28 |
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| Secondary | Number of Participants Currently Employed as Per Work Productivity and Activity Impairment Questionnaire: Anemic Symptoms Clinical Practice Version (WPAI-ANS-CPV) | WPAI-ANS-CPV is anemia specific questionnaire designed as self-reported quantitative assessment of social functioning related to work and regular daily activities. It contains 2 concepts-work productivity impairment measured via absenteeism(time missed from work), presenteeism(impairment at work) and regular daily activity impairment. WPAI questions (Q) were:1) currently employed,2) work time missed due to problem, 3) impairment while working due to problem, 4) overall work impairment due to problem, 5) activity impairment due to problem. WPAI generates 4 domain scores:percent (%) of work time missed(absenteeism),% of impairment while working(presenteeism),% of overall work impairment(absenteeism and presenteeism combined),% of activity impairment. Number of participants currently employed as per WPAI-ANS-CPV is presented. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles). | Posted | Count of Participants | Participants | Week 8, Week 12 and Week 28 |
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| Secondary | Change From Baseline in WPAI-ANS-CPV: Percent Time Missed From Work | WPAI-ANS-CPV is anemia specific questionnaire designed as self-reported quantitative assessment of social functioning related to work and regular daily activities. It contains 2 concepts-work productivity impairment measured via absenteeism (time missed from work), presenteeism (impairment at work) and regular daily activity impairment. WPAI questions (Q) were: 1) currently employed, 2) work time missed due to problem, 3) impairment while working due to problem, 4)overall work impairment due to problem, 5) activity impairment due to problem. Percent work time missed due to problem was a subscale and calculated as: Q2/(Q2+Q4) for those who were currently employed. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment and less productivity. Change from Baseline was calculated as post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Percentage of time | Baseline (Day 1), Week 8, Week 12 and Week 28 |
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| Secondary | Change From Baseline in WPAI-ANS-CPV: Mean Hours Missed From Work in the Past 7 Days | WPAI-ANS-CPV is anemia specific questionnaire designed as self-reported quantitative assessment of social functioning related to work and regular daily activities. It contains 2 concepts-work productivity impairment measured via absenteeism (time missed from work), presenteeism (impairment at work) and regular daily activity impairment. WPAI Qs were: 1) currently employed, 2) work time missed due to problem, 3) impairment while working due to problem, 4) overall work impairment due to problem, 5) activity impairment due to problem. Change from Baseline was calculated as post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. | Intent-to-Treat Population. Only those participants with data available at indicated time points are presented (presented by n=X in category titles). | Posted | Mean | Standard Deviation | Percentage of hours | Baseline (Day 1), Week 8, Week 12 and Week 28 |
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| Secondary | Change From Baseline in WPAI: Percent Impairment at Work | WPAI-ANS-CPV is anemia specific questionnaire designed as self-reported quantitative assessment of social functioning related to work and regular daily activities.It contains 2 concepts-work productivity impairment measured via absenteeism(time missed from work),presenteeism(impairment at work) and regular daily activity impairment.WPAI Qs were:1)currently employed,2)work time missed due to problem,3)impairment while working due to problem,4)overall work impairment due to problem,5)activity impairment due to problem. % Impairment while Working due to Problem was subscale and calculated as: Q5/10 for those who were currently employed and actually worked in past 7 days. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment and less productivity. Change from Baseline was calculated as post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before randomization date. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Percentage of impairment | Baseline (Day 1), Week 8, Week 12 and Week 28 |
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| Secondary | Change From Baseline in WPAI: Percent Overall Work Impairment | WPAI-ANS-CPV is anemia specific questionnaire designed as self-reported quantitative assessment of social functioning related to work and regular daily activities. It contains 2 concepts-work productivity impairment measured via absenteeism (time missed from work), presenteeism (impairment at work) and regular daily activity impairment. WPAI Qs were: 1) currently employed, 2) work time missed due to problem, 3) impairment while working due to problem, 4) overall work impairment due to problem, 5) activity impairment due to problem. Percent overall work impairment due to problem was a subscale and calculated as: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))×(Q5/10)] for those who were currently employed. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment. Change from Baseline was calculated as post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before randomization date. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Percentage of impairment | Baseline (Day 1), Week 8, Week 12 and Week 28 |
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| Secondary | Change From Baseline in WPAI: Percent Regular Daily Activity Impairment | WPAI-ANS-CPV is anemia specific questionnaire designed as self-reported quantitative assessment of social functioning related to work and regular daily activities.It contains 2 concepts-work productivity impairment measured via absenteeism (time missed from work), presenteeism (impairment at work) and regular daily activity impairment. WPAI Qs were: 1) currently employed, 2) work time missed due to problem, 3) impairment while working due to problem, 4) overall work impairment due to problem, 5) activity impairment due to problem. Percent activity impairment due to problem was a subscale and calculated as: Q5/10 for all respondents. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment. Change from Baseline was calculated as post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before randomization date. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Percentage of impairment | Baseline (Day 1), Week 8, Week 12 and Week 28 |
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| Secondary | Change From Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) Utility Score | The EQ-5D-5L is a self-assessment questionnaire, consisting of 5 items covering 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension is measured by a 5-point Likert scale (1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems). The responses for the five dimension together form a five-figure description of health state. Each of these five-figure health states have attached valuation (utility score), expressed as single index on a scale from 0-1, where 1 is full health and 0 is worst health. The higher the score the better the health status. Change from Baseline was calculated as post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. | Intent-to-Treat Population. Only those participants with data available at indicated time points are presented. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and Week 28 |
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| Secondary | Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score | The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 'the best health you can imagine' and 'the worst health you can imagine' at the time of completion. It is a self-assessment visual analogue scale, ranging from 0=worst imaginable to 100=best. Change from Baseline was calculated as post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. | Intent-to-Treat 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 28 |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) at Week 28 | SBP, DBP and MAP were measured with participants in a seated position after at least a 5-minute of rest. MAP is the average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | Millimeters of mercury (mmHg) | Baseline (Day 1) and Week 28 |
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| Secondary | Percentage of Participants With at Least One Blood Pressure (BP) Exacerbation Event | Percentage of participants with at least one BP event is presented. BP exacerbation is defined as: SBP exacerbation: SBP >= 25 mmHg increase from Baseline or SBP >= 180 mmHg; DBP exacerbation: DBP >= 15 mmHg increase from Baseline or DBP >= 110 mmHg. Percentage of participants with at least one BP event is presented. The percentage values presented has been rounded off. | Intent-to-Treat Population. | Posted | Number | Percentage of participants | Up to Week 28 |
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All cause mortality, serious adverse events (SAEs) and non-serious AEs were collected up to follow-up (Week 32).
Safety Population comprised of all randomized participants who received at least 1 dose of study treatment. Treatment emergent non-serious adverse events and serious adverse events are reported. One participant who was randomized to placebo accidently received daprodustat during the study and therefore was evaluated in the daprodustat treatment group for the safety outcomes
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 | Placebo | Participants received matching placebo once daily orally for up to 28 weeks followed by 4 weeks of follow-up. | 16 | 306 | 68 | 306 | 44 | 306 |
| EG001 | Daprodustat | Participants received daprodustat tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 milligrams (mg) once daily orally for up to 28 weeks, followed by 4 weeks of follow-up. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (11 to 12 grams per deciliter [g/dL]) | 10 | 308 | 62 | 308 | 49 | 308 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| End stage renal disease | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Azotaemia | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Chronic kidney disease | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| IgA nephropathy | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Nephropathy toxic | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Nephrotic syndrome | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Renal haematoma | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Cardiac failure congestive | 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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| Acute coronary syndrome | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Left ventricular failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Acute myocardial infarction | 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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| Arrhythmia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Atrial thrombosis | 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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| Coronary artery disease | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Mitral valve incompetence | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Right ventricular failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Tricuspid valve incompetence | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Cellulitis | 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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| Pneumonia | 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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| Urosepsis | 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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| Diabetic foot infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diabetic gastropathy | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute interstitial pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Kidney rupture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Transplant dysfunction | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atlantoaxial instability | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Oedema peripheral | General 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 12, 2020 | Sep 7, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, 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 |
Not provided
Not provided
Not provided
| Male |
|
| ASIAN: CENTRAL/SOUTH ASIAN HERITAGE |
|
| ASIAN: JAPANESE/EASTASIAN/SOUTHEAST ASIAN HERITAGE |
|
| ASIAN: MIXED ASIAN RACE |
|
| BLACK OR AFRICAN AMERICAN |
|
| NATIVE HAWAIIAN/OTHER PACIFIC ISLANDER |
|
| WHITE |
|
| BLACK OR AFRICAN AMERICAN AND WHITE |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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|
| Units | Counts |
|---|---|
| Participants |
|
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| Participants |
|
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|
|
|
Participants received daprodustat tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 milligrams (mg) once daily orally for up to 28 weeks, followed by 4 weeks of follow-up. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (11 to 12 grams per deciliter [g/dL])
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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|
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|
|
|
Participants received daprodustat tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 milligrams (mg) once daily orally for up to 28 weeks, followed by 4 weeks of follow-up. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (11 to 12 grams per deciliter [g/dL])
|
|
|
|
Participants received daprodustat tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 milligrams (mg) once daily orally for up to 28 weeks, followed by 4 weeks of follow-up. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (11 to 12 grams per deciliter [g/dL])
|
|
Participants received daprodustat tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 milligrams (mg) once daily orally for up to 28 weeks, followed by 4 weeks of follow-up. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (11 to 12 grams per deciliter [g/dL])
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
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| Units |
|---|
| Counts |
|---|
| Participants |
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|