Trial · NCT02278341
Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis
NCT02278341, Phase 3, Completed, Astellas Pharma Europe B.V.; results first posted 2020-08-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis. Trials, record NCT02278341. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02278341
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis
- NCT number
- NCT02278341
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 838 participants, actual
- Lead sponsor
- Astellas Pharma Europe B.V.
- Conditions
- Anemia, End Stage Renal Disease (ESRD)
- Interventions
- Roxadustat, Epoetin alfa, Darbepoetin alfa, Iron
- First posted
- 2014-10-30
- Last updated
- 2024-11-27
- Other registries' IDs
- eudract:2013-001497-16
- Results first posted
- 2020-08-26
- Limitations and caveats
Overall 838 were randomized to receive treatment. Two participants randomized to the pooled ESA treatment group were excluded due to GCP violations and their data was excluded. Total of 836 were considered randomized.
Source ClinicalTrials.gov
Registered outcomes45
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)] | Baseline and weeks 28 to 36 | Baseline Hb was defined as the mean of four central laboratory Hb values; four latest Hb values prior or on the same date as the first study drug intake. For participants who did not have an available Hb value during the week 28-36 period, imputation rules were applied. For analyses without rescue therapy, participants who used rescue therapy after the initiation of rescue therapy were set to missing for 6 weeks from the start date of rescue therapy. If no Hb value was available, an imputation technique was used, with the mean of all available values from Day 1 to minimum (End of Efficacy Emergent Period) carried forward. |
| Primary | Change From BL to the Average Hb in Weeks 28 to 52 Regardless of Rescue Therapy [US (FDA)] | Baseline and weeks 28 to 52 | Baseline Hb was defined as the mean of four central laboratory Hb values: four latest Hb values prior or on the same date as first study drug intake. Change from baseline to the average Hb are observed values. Missing hemoglobin data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model with treatment, baseline hemoglobin, randomization stratification factors and the available non missing hemoglobin for each scheduled week. |
| Secondary | Percentage of Participants With Hb Response During Weeks 28 to 36 | Weeks 28 to 36 | Hb response during weeks 28-36, was defined as mean Hb from 10-12 g/dL without receiving rescue therapy in the 6 weeks prior to, or during, the evaluation period. The percentages and 95% CI were unadjusted, the exact method of Clopper-Pearson was used for 95% CI. The Efficacy Emergent Period was defined as the evaluation period from the Analysis date of first dose intake up to end of treatment (EOT) Visit or last non-missing Hb assessment (for participants who died during the treatment period). |
| Secondary | Change From BL in Low Density Lipoprotein Cholesterol (LDL-C) to the Average LDL-C of Weeks 12 to 28 | Baseline and weeks 12 to 28 | Baseline LDL was defined as the LDL value on Day 1. If this value was missing, the latest value prior to first study drug administration was used. |
| Secondary | Mean Monthly Intravenous (IV) Iron Use | Day 1 to week 36 | Participants with no or missing medication records of IV Iron have their monthly IV Iron use set to 0 mg. For participants who took IV Iron, but without a dosing frequency, the average values were set to missing. |
| Secondary | Change From BL in Short Form-36 (SF-36) Health Survey Physical Functioning (PF) Sub-score to the Average of Weeks 12 to 28 | Baseline and weeks 12 to 28 | Baseline SF-36 PF was defined as the SF-36 PF value on Day 1.The SF-36 is a Quality of Life (QoL) instrument designed to assess generic health concepts relevant across age, disease, and treatment groups. The SF-36 contains 36 items that measure eight scales: (1) physical functioning (PF); (2) role limitations due to physical health problems (RP); (3) bodily pain (BP); (4) social functioning (SF); (5) general health perceptions (GH); (6) role limitations due to emotional problems (RE); (7) vitality, energy or fatigue (VT); and (8) mental health(MH). Each scale is transformed into 0-100 score, with higher scores indicating better health status. The SF-36 PF consists of 11 questions focused on health and ability to do usual activities, with higher scores indicating better health status. |
| Secondary | Change From BL in SF-36 Vitality (VT) Sub-score to the Average of Weeks 12 to 28 | Baseline and weeks 12 to 28 | Baseline VT Subscore was defined as the VT value on Day 1. The SF-36 is a QoL instrument designed to assess generic health concepts relevant across age, disease, and treatment groups. The SF-36 vitality has four questions with score range from 0-100 with higher scores indicating better vitality status. |
| Secondary | Change From BL in Mean Arterial Pressure (MAP) to the Average of Weeks 20 to 28 | Baseline and weeks 20 to 28 | Baseline MAP was defined as the MAP value on Day 1. If this value was missing, the latest value prior to first study drug administration was used. Mean Arterial Pressure (MAP) is derived as: MAP = (2/3)\*DBP + (1/3)\*SBP. |
| Secondary | Time to First Occurrence of an Increase in Blood Pressure | Weeks 1 to 36 | Increase in Blood Pressure was defined as either: Systolic Blood Pressure (SBP) ≥ 170 mmHg and an increase from BL ≥ 20 mmHg, or as: Diastolic Blood Pressure (DBP) ≥ 100 mmHg and an increase from BL ≥ 15 mmHg. For participants who have experienced more than one event, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. |
| Secondary | Change From BL in Mean Arterial Pressure (MAP) to the Average MAP Value of Weeks 20 to 28 | Baseline and weeks 20 to 28 | Baseline MAP was defined as the MAP value on day 1. If this value was missing, the latest value prior to first study drug administration was used. Mean Arterial Pressure (MAP) is derived as: MAP = (2/3)\*DBP + (1/3)\*SBP. |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 registered outcomesOutcomes45
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)] | Baseline and weeks 28 to 36 | The analysis population was the Per Protocol Set (PPS) which consisted of all Full Analysis Set (FAS) participants who did not meet any of exclusion criteria from the PPS. The FAS consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose valid Hb assessment. | g/dL | LEAST_SQUARES_MEAN |
| PRIMARY | Change From BL to the Average Hb in Weeks 28 to 52 Regardless of Rescue Therapy [US (FDA)] | Baseline and weeks 28 to 52 | The analysis population was the All Randomized, which consisted of participants who received at least one dose of study drug, and who had available data. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Hb Response During Weeks 28 to 36 | Weeks 28 to 36 | The analysis population was the PPS. | Percentage of participants | NUMBER |
| SECONDARY | Change From BL in Low Density Lipoprotein Cholesterol (LDL-C) to the Average LDL-C of Weeks 12 to 28 | Baseline and weeks 12 to 28 | The analysis population was the FAS, with participants who had available data. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Monthly Intravenous (IV) Iron Use | Day 1 to week 36 | The analysis population was the FAS, with participants who had available data. | mg per month | LEAST_SQUARES_MEAN |
| SECONDARY | Change From BL in Short Form-36 (SF-36) Health Survey Physical Functioning (PF) Sub-score to the Average of Weeks 12 to 28 | Baseline and weeks 12 to 28 | The analysis population was the PPS, with participants who had available data. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From BL in SF-36 Vitality (VT) Sub-score to the Average of Weeks 12 to 28 | Baseline and weeks 12 to 28 | The analysis population was the PPS, with participants who had available data. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From BL in Mean Arterial Pressure (MAP) to the Average of Weeks 20 to 28 | Baseline and weeks 20 to 28 | The analysis population was the PPS, with participants who had available data. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Occurrence of an Increase in Blood Pressure | Weeks 1 to 36 | The analysis population was the PPS, with participants who had available data. | Percentage of participants | NUMBER |
| SECONDARY | Change From BL in Mean Arterial Pressure (MAP) to the Average MAP Value of Weeks 20 to 28 | Baseline and weeks 20 to 28 | The analysis population was the FAS, with participants who had available data. | mmHg | LEAST_SQUARES_MEAN |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 outcomesResults by group386
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)] | Roxadustat | 0.428 | 95% Confidence Interval 0.350 to 0.506 | g/dL | |
| Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)] | ESA (Erythropoiesis-Stimulating Agent) | 0.193 | 95% Confidence Interval 0.117 to 0.268 | g/dL | |
| Change From BL to the Average Hb in Weeks 28 to 52 Regardless of Rescue Therapy [US (FDA)] | Roxadustat | 0.363 | 95% Confidence Interval 0.288 to 0.438 | g/dL | |
| Change From BL to the Average Hb in Weeks 28 to 52 Regardless of Rescue Therapy [US (FDA)] | ESA (Erythropoiesis-Stimulating Agent) | 0.192 | 95% Confidence Interval 0.121 to 0.262 | g/dL | |
| Percentage of Participants With Hb Response During Weeks 28 to 36 | Roxadustat | 84.2 | 95% Confidence Interval 80.2 to 87.7 | Percentage of participants | |
| Percentage of Participants With Hb Response During Weeks 28 to 36 | ESA (Erythropoiesis-Stimulating Agent) | 82.4 | 95% Confidence Interval 78.3 to 86.0 | Percentage of participants | |
| Change From BL in Low Density Lipoprotein Cholesterol (LDL-C) to the Average LDL-C of Weeks 12 to 28 | Roxadustat | -0.459 | 95% Confidence Interval -0.517 to -0.401 | mmol/L | |
| Change From BL in Low Density Lipoprotein Cholesterol (LDL-C) to the Average LDL-C of Weeks 12 to 28 | ESA (Erythropoiesis-Stimulating Agent) | -0.082 | 95% Confidence Interval -0.138 to -0.026 | mmol/L | |
| Mean Monthly Intravenous (IV) Iron Use | Roxadustat | 21.6 | 95% Confidence Interval 14.0 to 29.3 | mg per month | |
| Mean Monthly Intravenous (IV) Iron Use | ESA (Erythropoiesis-Stimulating Agent) | 53.5 | 95% Confidence Interval 46.0 to 61.1 | mg per month |
1 to 10 of 386Source ClinicalTrials.gov
See all 386 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Roxadustat | 415 | |
| Overall Study | STARTED | ESA (Erythropoiesis-Stimulating Agent) | 421 | |
| Overall Study | Received Treatment | Roxadustat | 414 | |
| Overall Study | Received Treatment | ESA (Erythropoiesis-Stimulating Agent) | 420 | |
| Overall Study | COMPLETED | Roxadustat | 297 | |
| Overall Study | COMPLETED | ESA (Erythropoiesis-Stimulating Agent) | 329 | |
| Overall Study | NOT COMPLETED | Roxadustat | 118 | |
| Overall Study | NOT COMPLETED | ESA (Erythropoiesis-Stimulating Agent) | 92 |
Source ClinicalTrials.gov
Adverse events880
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 | Hyperparathyroidism secondary | Endocrine disorders | Roxadustat | 21 | 414 | 21 |
| other | Hyperparathyroidism secondary | Endocrine disorders | ESA (Erythropoiesis-Stimulating Agent) | 16 | 420 | 17 |
| other | Diarrhoea | Gastrointestinal disorders | Roxadustat | 33 | 414 | 51 |
| other | Diarrhoea | Gastrointestinal disorders | ESA (Erythropoiesis-Stimulating Agent) | 32 | 420 | 60 |
| other | Nausea | Gastrointestinal disorders | Roxadustat | 27 | 414 | 29 |
| other | Nausea | Gastrointestinal disorders | ESA (Erythropoiesis-Stimulating Agent) | 8 | 420 | 10 |
| other | Bronchitis | Infections and infestations | Roxadustat | 29 | 414 | 38 |
| other | Bronchitis | Infections and infestations | ESA (Erythropoiesis-Stimulating Agent) | 27 | 420 | 34 |
| other | Upper respiratory tract infection | Infections and infestations | Roxadustat | 14 | 414 | 19 |
| other | Upper respiratory tract infection | Infections and infestations | ESA (Erythropoiesis-Stimulating Agent) | 21 | 420 | 29 |
1 to 10 of 880Source ClinicalTrials.gov
See all 880 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roxadustat | 78 | 414 |
| Total, all-cause mortality | ESA (Erythropoiesis-Stimulating Agent) | 59 | 420 |
| Total, other adverse events | Roxadustat | 210 | 414 |
| Total, other adverse events | ESA (Erythropoiesis-Stimulating Agent) | 209 | 420 |
| Total, serious adverse events | Roxadustat | 210 | 414 |
| Total, serious adverse events | ESA (Erythropoiesis-Stimulating Agent) | 189 | 420 |
Source ClinicalTrials.gov
Papers2
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 |
|---|---|
| Roxadustat vs ESA (Erythropoiesis-Stimulating Agent): deaths from any cause | Trial comparisons |
| Roxadustat vs ESA (Erythropoiesis-Stimulating Agent): serious adverse events | 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/NCT02278341
GET https://conductscience.org/api/trials/v1/NCT02278341/registered?page=2