Trial · NCT02021318
Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa
NCT02021318, Phase 3, Completed, Astellas Pharma Europe B.V.; results first posted 2021-03-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa. Trials, record NCT02021318. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02021318
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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 Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa
- NCT number
- NCT02021318
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 616 participants, actual
- Lead sponsor
- Astellas Pharma Europe B.V.
- Conditions
- Anemia in Chronic Kidney Disease in Non-dialysis Patients
- Interventions
- Roxadustat, Darbepoetin alfa
- First posted
- 2013-12-27
- Last updated
- 2024-11-14
- Other registries' IDs
- eudract:2013-000951-42
- Results first posted
- 2021-03-29
Source ClinicalTrials.gov
Registered outcomes61
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Hb Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy | Baseline to week 24 | Hb response was measured as Yes or No. Response Yes (responders) was defined as: Hb ≥11.0 g/dL and Hb change from baseline by ≥ 1.0 g/dL, for participants with baseline Hb \> 8.0 g/dL; or Hb change from baseline by ≥ 2.0 g/dL, for participants with baseline Hb ≤ 8.0 g/dL at two consecutive visits with available data separated at least 5 days during the first 24 weeks of treatment without having received rescue therapy (red blood cell \[RBC\] transfusion for all participants or darbepoetin for roxadustat treated participant). |
| Secondary | Change From Baseline in Hb to the Average Hb of Weeks 28 to 36 Without Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period | Baseline and weeks 28 to 36 | Baseline Hb was defined as the mean of all available central laboratory Hb values collected before or including the date of first study drug intake (predose). |
| Secondary | Change From Baseline 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-C was defined as the LDL-C value on day 1. If this value was missing, the latest value prior to first study drug administration was used. |
| Secondary | Time to First Intravenous Iron Use | Weeks 6, 12, 18, 24, 30 and 36 | Participants were analyzed during the efficacy emergent period. 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). For participants who had received more than one intravenous iron, 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. Percentage of participants were reported in this outcome measure. |
| Secondary | Change From Baseline in Short Form-36 (SF-36) Physical Functioning (PF) Sub-Score to the Average PF Sub Score in 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 measured eight scales: (1) physical functioning; (2) role limitations due to physical health problems; (3) bodily pain; (4) social functioning; (5) general health perceptions; (6) role limitations due to emotional problems; (7) vitality, energy or fatigue; and (8) mental health. Each scale is transformed into 0-100 score, with higher scores indicating better health status. The SF-36 PF consisted of 11 questions that focused on health and ability to do usual activities, with higher scores indicating better health status. |
| Secondary | Change From Baseline in SF-36 Vitality (VT) Sub-Score to the Average VT Sub-Score in 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 Baseline in Mean Arterial Pressure (MAP) to the Average MAP Value in Weeks 20 to 28: Per Protocol Set | 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. MAP was derived as: MAP = (2/3)\*diastolic blood pressure (DBP) + (1/3)\*systolic blood pressure (SBP). |
| Secondary | Time to First Occurrence of Hypertension During Weeks 1 to 36: Per Protocol Set | Weeks 1 to 36 | Hypertension was defined as either SBP ≥ 170 mmHg and an increase from baseline ≥ 20 mmHg or as DBP ≥ 110 mmHg and an increase from baseline ≥ 15 mmHg. For participants who had 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. Percentage of participants were reported in this outcome measure. |
| Secondary | Change From Baseline in MAP to the Average MAP Value in Weeks 20 to 28: Full Analysis Set | 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. MAP was derived as: MAP = (2/3)\*DBP + (1/3)\*SBP. |
| Secondary | Time to First Occurrence of Hypertension During Weeks 1 to 36: Full Analysis Set | Weeks 1 to 36 | Hypertension was defined as either SBP ≥ 170 mmHg and an increase from baseline ≥ 20 mmHg or as DBP ≥ 110 mmHg and an increase from baseline ≥ 15 mmHg. For participants who had 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. Percentage of participants were reported in this outcome measure. |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 registered outcomesOutcomes61
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Hb Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy | Baseline to week 24 | 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. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Hb to the Average Hb of Weeks 28 to 36 Without Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period | Baseline and weeks 28 to 36 | The analysis population was the PPS, with participants who had available data. | g/dL | MEAN |
| SECONDARY | Change From Baseline 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. | Millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Time to First Intravenous Iron Use | Weeks 6, 12, 18, 24, 30 and 36 | The analysis population was the FAS. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Short Form-36 (SF-36) Physical Functioning (PF) Sub-Score to the Average PF Sub Score in 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 | MEAN |
| SECONDARY | Change From Baseline in SF-36 Vitality (VT) Sub-Score to the Average VT Sub-Score in 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 | MEAN |
| SECONDARY | Change From Baseline in Mean Arterial Pressure (MAP) to the Average MAP Value in Weeks 20 to 28: Per Protocol Set | Baseline and weeks 20 to 28 | The analysis population was the PPS, with participants who had available data. | Millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Time to First Occurrence of Hypertension During Weeks 1 to 36: Per Protocol Set | Weeks 1 to 36 | The analysis population was the PPS. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in MAP to the Average MAP Value in Weeks 20 to 28: Full Analysis Set | Baseline and weeks 20 to 28 | The analysis population was the FAS, with participants who had available data. | mmHg | MEAN |
| SECONDARY | Time to First Occurrence of Hypertension During Weeks 1 to 36: Full Analysis Set | Weeks 1 to 36 | The analysis population was the FAS. | Percentage of Participants | NUMBER |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 outcomesResults by group548
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Hb Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy | Roxadustat | 89.5 | Percentage of Participants | ||
| Percentage of Participants With a Hb Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy | Darbepoetin Alfa | 78.0 | Percentage of Participants | ||
| Change From Baseline in Hb to the Average Hb of Weeks 28 to 36 Without Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period | Roxadustat | 1.848 | Standard Deviation 1.079 | g/dL | |
| Change From Baseline in Hb to the Average Hb of Weeks 28 to 36 Without Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period | Darbepoetin Alfa | 1.839 | Standard Deviation 0.973 | g/dL | |
| Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) to the Average LDL-C of Weeks 12 to 28 | Roxadustat | -0.352 | Standard Deviation 0.772 | Millimoles per liter (mmol/L) | |
| Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) to the Average LDL-C of Weeks 12 to 28 | Darbepoetin Alfa | 0.049 | Standard Deviation 0.705 | Millimoles per liter (mmol/L) | |
| Time to First Intravenous Iron Use | Roxadustat | Week 6 | 0 | 95% Confidence Interval 0 to 0 | Percentage of participants |
| Time to First Intravenous Iron Use | Darbepoetin Alfa | Week 6 | 2.8 | 95% Confidence Interval 0.9 to 4.6 | Percentage of participants |
| Time to First Intravenous Iron Use | Roxadustat | Week 12 | 1.3 | 95% Confidence Interval 0 to 2.5 | Percentage of participants |
| Time to First Intravenous Iron Use | Darbepoetin Alfa | Week 12 | 6.7 | 95% Confidence Interval 3.8 to 9.6 | Percentage of participants |
1 to 10 of 548Source ClinicalTrials.gov
See all 548 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Roxadustat | 323 | |
| Overall Study | STARTED | Darbepoetin Alfa | 293 | |
| Overall Study | COMPLETED | Roxadustat | 250 | |
| Overall Study | COMPLETED | Darbepoetin Alfa | 230 | |
| Overall Study | NOT COMPLETED | Roxadustat | 73 | |
| Overall Study | NOT COMPLETED | Darbepoetin Alfa | 63 |
Source ClinicalTrials.gov
Adverse events800
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 | Atrial fibrillation | Cardiac disorders | Roxadustat | 16 | 323 | 18 |
| other | Atrial fibrillation | Cardiac disorders | Darbepoetin Alfa | 11 | 293 | 15 |
| other | Constipation | Gastrointestinal disorders | Roxadustat | 21 | 323 | 23 |
| other | Constipation | Gastrointestinal disorders | Darbepoetin Alfa | 15 | 293 | 18 |
| other | Diarrhoea | Gastrointestinal disorders | Roxadustat | 27 | 323 | 38 |
| other | Diarrhoea | Gastrointestinal disorders | Darbepoetin Alfa | 28 | 293 | 36 |
| other | Nausea | Gastrointestinal disorders | Roxadustat | 35 | 323 | 40 |
| other | Nausea | Gastrointestinal disorders | Darbepoetin Alfa | 24 | 293 | 26 |
| other | Vomiting | Gastrointestinal disorders | Roxadustat | 21 | 323 | 31 |
| other | Vomiting | Gastrointestinal disorders | Darbepoetin Alfa | 19 | 293 | 22 |
1 to 10 of 800Source ClinicalTrials.gov
See all 800 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roxadustat | 40 | 323 |
| Total, all-cause mortality | Darbepoetin Alfa | 37 | 293 |
| Total, other adverse events | Roxadustat | 223 | 323 |
| Total, other adverse events | Darbepoetin Alfa | 203 | 293 |
| Total, serious adverse events | Roxadustat | 209 | 323 |
| Total, serious adverse events | Darbepoetin Alfa | 181 | 293 |
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Roxadustat vs Darbepoetin Alfa: Number of Particpants Who Received RBC Transfusions | Trial comparisons |
| Roxadustat vs Darbepoetin Alfa: deaths from any cause | Trial comparisons |
| Roxadustat vs Darbepoetin Alfa: Number of Participants Who Received Rescue Therapy (Composite of RBC Transfusions (All Participants) and Darbepoetin Alfa Use (Roxadustat Treated Participants Only) | Trial comparisons |
| Roxadustat vs Darbepoetin Alfa: Number of Participants With End Stage Renal Disease (ESRD) | Trial comparisons |
| Roxadustat vs Darbepoetin Alfa: 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/NCT02021318
GET https://conductscience.org/api/trials/v1/NCT02021318/registered?page=2