Trial · NCT02876835
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
NCT02876835, Phase 3, Completed, GlaxoSmithKline; results first posted 2022-04-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND). Trials, record NCT02876835. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02876835
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
- NCT number
- NCT02876835
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,872 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- Daprodustat, Darbepoetin alfa, Placebo, Iron Therapy
- First posted
- 2016-08-24
- Last updated
- 2024-04-02
- Other registries' IDs
- eudract:2016-000542-65
- Results first posted
- 2022-04-14
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis) | Up to 4.3 person-years for CV follow-up time period | Time to MACE defined as time to first occurrence of Clinical Events Committee (CEC) adjudicated MACE (composite of all-cause mortality, non-fatal myocardial infarction \[MI\] and non-fatal stroke) was analyzed using a Cox proportional hazards regression model with treatment group, current erythropoiesis-stimulating agents (ESA) use at randomization and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) plus (+) 1. The incidence rate per 100 person years calculated as (100 multiplied \[\*\] number of participants with at least 1 event) divided by \[/\] first event person-years) is presented along with 95 percent (%) confidence interval (CI). First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. |
| Primary | Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52) | Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52) | Blood samples were collected from participants for Hgb measurements. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputation methods. Change from Baseline was defined as post-Baseline value minus (-) Baseline value. Baseline was defined as 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 Hgb, current ESA use and region. |
| Secondary | Time to First Occurrence of Adjudicated MACE During CV Events Follow-up Time Period (Superiority Analysis) | Up to 4.3 person-years for CV follow-up time period | Time to MACE defined as the time to first occurrence of CEC adjudicated MACE was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariate. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method. |
| Secondary | Time to First Occurrence of Adjudicated MACE or Thromboembolic Event During CV Events Follow-up Time Period | Up to 4.3 person-years for CV follow-up time period | Time to first occurrence of adjudicated MACE or thromboembolic event (vascular access thrombosis, symptomatic deep vein thrombosis or symptomatic pulmonary embolism) was analyzed using a Cox proportional hazards regression model with with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method. |
| Secondary | Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure During CV Events Follow-up Time Period | Up to 4.3 person-years for CV follow-up time period | Time to first occurrence of adjudicated MACE or hospitalization for heart failure was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method. |
| Secondary | Time to First Occurrence of Chronic Kidney Disease (CKD) Progression During CV Events Follow-up Time Period | Up to 4.3 person-years for CV follow-up time period | Progression of CKD defined as: 40% decline in estimated glomerular filtration rate (eGFR) from Baseline or end stage renal disease (ESRD) as defined by either initiating chronic dialysis for \>=90 days or not initiating chronic dialysis when dialysis is indicated or kidney transplantation. Time to first occurrence of CKD progression was analyzed using Fine and Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) +1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. |
| Secondary | Time to First Occurrence of Adjudicated All-Cause Mortality During Vital Status for Follow-up Time Period | Up to 4.3 person-years for vital status follow-up time period | Time to first occurrence of adjudicated all-cause mortality was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the vital status follow-up time period. |
| Secondary | Time to First Occurrence of Adjudicated CV Mortality During CV Events Follow-up Time Period | Up to 4.3 person-years for CV follow-up time period | Time to first occurrence of adjudicated CV mortality was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. |
| Secondary | Time to First Occurrence of Adjudicated Myocardial Infarction (MI) (Fatal and Non-Fatal) During CV Events Follow-up Time Period | Up to 4.3 person-years for CV follow-up time period | Time to first occurrence of adjudicated MI (fatal and non-fatal) was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. |
| Secondary | Time to First Occurrence of Adjudicated Stroke (Fatal and Non-Fatal) During CV Events Follow-up Time Period | Up to 4.3 person-years for CV follow-up time period | Time to first occurrence of adjudicated stroke (fatal and non-fatal) was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis) | Up to 4.3 person-years for CV follow-up time period | All Randomized (Intent-to-treat \[ITT\]) Population comprised of all randomized participants. Participants were analyzed according to the treatment to which they were randomized. | Events per 100 person years | NUMBER |
| PRIMARY | Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52) | Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52) | All Randomized (ITT) Population. | Grams per deciliter | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Occurrence of Adjudicated MACE During CV Events Follow-up Time Period (Superiority Analysis) | Up to 4.3 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of Adjudicated MACE or Thromboembolic Event During CV Events Follow-up Time Period | Up to 4.3 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure During CV Events Follow-up Time Period | Up to 4.3 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of Chronic Kidney Disease (CKD) Progression During CV Events Follow-up Time Period | Up to 4.3 person-years for CV follow-up time period | All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed. Additionally, this analysis population was restricted to those with a Baseline eGFR \>=15milliliter per minute (mL/min). | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of Adjudicated All-Cause Mortality During Vital Status for Follow-up Time Period | Up to 4.3 person-years for vital status follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of Adjudicated CV Mortality During CV Events Follow-up Time Period | Up to 4.3 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of Adjudicated Myocardial Infarction (MI) (Fatal and Non-Fatal) During CV Events Follow-up Time Period | Up to 4.3 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
| SECONDARY | Time to First Occurrence of Adjudicated Stroke (Fatal and Non-Fatal) During CV Events Follow-up Time Period | Up to 4.3 person-years for CV follow-up time period | All Randomized (ITT) Population. | Events per 100 person years | NUMBER |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 outcomesResults by group236
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis) | Daprodustat | 10.86 | 95% Confidence Interval 9.80 to 12.02 | Events per 100 person years | |
| Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis) | Darbepoetin Alfa | 10.63 | 95% Confidence Interval 9.58 to 11.77 | Events per 100 person years | |
| Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52) | Daprodustat | 0.74 | Standard Error 0.019 | Grams per deciliter | |
| Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52) | Darbepoetin Alfa | 0.66 | Standard Error 0.019 | Grams per deciliter | |
| Time to First Occurrence of Adjudicated MACE During CV Events Follow-up Time Period (Superiority Analysis) | Daprodustat | 10.86 | 95% Confidence Interval 9.80 to 12.02 | Events per 100 person years | |
| Time to First Occurrence of Adjudicated MACE During CV Events Follow-up Time Period (Superiority Analysis) | Darbepoetin Alfa | 10.63 | 95% Confidence Interval 9.58 to 11.77 | Events per 100 person years | |
| Time to First Occurrence of Adjudicated MACE or Thromboembolic Event During CV Events Follow-up Time Period | Daprodustat | 12.34 | 95% Confidence Interval 11.19 to 13.57 | Events per 100 person years | |
| Time to First Occurrence of Adjudicated MACE or Thromboembolic Event During CV Events Follow-up Time Period | Darbepoetin Alfa | 11.77 | 95% Confidence Interval 10.65 to 12.98 | Events per 100 person years | |
| Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure During CV Events Follow-up Time Period | Daprodustat | 13.16 | 95% Confidence Interval 11.97 to 14.44 | Events per 100 person years | |
| Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure During CV Events Follow-up Time Period | Darbepoetin Alfa | 12.22 | 95% Confidence Interval 11.08 to 13.46 | Events per 100 person years |
1 to 10 of 236Source ClinicalTrials.gov
See all 236 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-in Period: Placebo (Week-4 to Day 1) | STARTED | Daprodustat | 1,937 | |
| Run-in Period: Placebo (Week-4 to Day 1) | STARTED | Darbepoetin Alfa | 1,935 | |
| Run-in Period: Placebo (Week-4 to Day 1) | COMPLETED | Daprodustat | 1,937 | |
| Run-in Period: Placebo (Week-4 to Day 1) | COMPLETED | Darbepoetin Alfa | 1,935 | |
| Run-in Period: Placebo (Week-4 to Day 1) | NOT COMPLETED | Daprodustat | 0 | |
| Run-in Period: Placebo (Week-4 to Day 1) | NOT COMPLETED | Darbepoetin Alfa | 0 | |
| Treatment Period (51.1 Month) | STARTED | Daprodustat | 1,937 | |
| Treatment Period (51.1 Month) | STARTED | Darbepoetin Alfa | 1,935 | |
| Treatment Period (51.1 Month) | COMPLETED | Daprodustat | 1,873 | |
| Treatment Period (51.1 Month) | COMPLETED | Darbepoetin Alfa | 1,870 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events2,310
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypertension | Vascular disorders | Run-in Period: Placebo | 0 | 3,872 | 0 |
| other | Hypertension | Vascular disorders | Daprodustat | 247 | 1,937 | 317 |
| other | Hypertension | Vascular disorders | Darbepoetin Alfa | 264 | 1,933 | 339 |
| other | Oedema peripheral | General disorders | Run-in Period: Placebo | 0 | 3,872 | 0 |
| other | Oedema peripheral | General disorders | Daprodustat | 198 | 1,937 | 239 |
| other | Oedema peripheral | General disorders | Darbepoetin Alfa | 162 | 1,933 | 199 |
| other | Urinary tract infection | Infections and infestations | Run-in Period: Placebo | 0 | 3,872 | 0 |
| other | Urinary tract infection | Infections and infestations | Daprodustat | 164 | 1,937 | 245 |
| other | Urinary tract infection | Infections and infestations | Darbepoetin Alfa | 153 | 1,933 | 199 |
| other | Diarrhoea | Gastrointestinal disorders | Run-in Period: Placebo | 0 | 3,872 | 0 |
1 to 10 of 2,310Source ClinicalTrials.gov
See all 2,310 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Run-in Period: Placebo | 0 | 3,872 |
| Total, all-cause mortality | Daprodustat | 301 | 1,937 |
| Total, all-cause mortality | Darbepoetin Alfa | 298 | 1,935 |
| Total, other adverse events | Run-in Period: Placebo | 0 | 3,872 |
| Total, other adverse events | Daprodustat | 851 | 1,937 |
| Total, other adverse events | Darbepoetin Alfa | 825 | 1,933 |
| Total, serious adverse events | Run-in Period: Placebo | 63 | 3,872 |
| Total, serious adverse events | Daprodustat | 850 | 1,937 |
| Total, serious adverse events | Darbepoetin Alfa | 703 | 1,933 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Daprodustat vs Darbepoetin Alfa: Number of Participants With at Least One BP Exacerbation Event During Study | Trial comparisons |
| Daprodustat vs Darbepoetin Alfa: Number of Hgb Responders in the Hgb Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02876835
GET https://conductscience.org/api/trials/v1/NCT02876835/registered?page=2