Trial · NCT02174731
Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.
NCT02174731, Phase 3, Completed, AstraZeneca; results first posted 2019-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis. Trials, record NCT02174731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02174731
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.
- NCT number
- NCT02174731
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,133 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Anemia
- Interventions
- Roxadustat, Epoetin alfa
- First posted
- 2014-06-25
- Last updated
- 2019-12-16
- Results first posted
- 2019-12-16
- Limitations and caveats
- 27 participants were excluded from the analysis due to Good Clinical Practice violations or system technical issues (17 in the roxadustat group and 10 in the epoetin alfa group).
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 | Baseline (Day 1, Week 0), Week 28 to 52 | Baseline Hb was defined as the mean of the three last central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to the participants mean level from Week 28 to Week 52 was analyzed using a missing at random (MAR) based multiple imputation Analysis of Covariance (ANCOVA). Baseline Hb was used as a covariate and treatment group, cardiovascular (CV) history, geographic region and dialysis duration as fixed effects. The adjusted least squares (LS) mean estimates of change from baseline during Week 28 to Week 52 are presented. |
| Secondary | Change in Hb From Baseline to the Mean Level During the Evaluation Period (Week 28 to Week 36) Without Having Received Rescue Therapy Within 6 Weeks Prior to and During the 8-Week Evaluation Period | Baseline (Day 1, Week 0), Week 28 to 36 | Baseline Hb was defined as the mean of the three last central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to the participants mean level from Week 28 to Week 36,without having received rescue therapy within 6 weeks prior to and during this 8 week evaluation period was analysed using Mixed Model of Repeated Measures (MMRM). Baseline Hb was used as a covariate and treatment group, CV history, geographic region and dialysis duration as fixed effects. The adjusted LS mean estimates of change from baseline during Week 28 to Week 36 are presented for participants that did not receive rescue therapy within 6 weeks prior to and during this 8-week evaluation period. |
| Secondary | Proportion of Total Time of Hb Within the Interval of >=10 g/dL From Week 28 to Week 52 | Week 28 to 52 | The proportion of total time was computed as follows: For each participant, the recorded Hb values were first linearly interpolated between measurements. The time this interpolated curve was \>=10 g/dL was computed and subsequently divided by the time between the measurements from Week 28 to Week 52. The difference between roxadustat and epoetin alfa were compared using ANCOVA. Baseline Hb was used as a covariate and the treatment groups, CV history, geographic region and dialysis duration as fixed effects. |
| Secondary | Proportion of Total Time of Hb Within the Interval of 10 to 12 g/dL From Week 28 to Week 52 | Week 28 to 52 | The proportion of total time was computed as follows: For each participant, the recorded Hb values were first linearly interpolated between measurements. The time this interpolated curve was within 10-12 g/dL was computed and subsequently divided by the time between the measurement from Week 28 to 52. The difference between roxadustat and epoetin alfa were compared using ANCOVA. Baseline Hb was used as a covariate and the treatment groups, CV history, geographic region and dialysis duration as fixed effects. |
| Secondary | Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24 | Baseline (Day 1, Week 0) to Week 24 | Baseline LDL was defined as the last result obtained prior to randomization. Mean changes in LDL cholesterol from baseline to Week 24 was analysed using ANCOVA. Baseline Hb and baseline LDL were used as covariates and treatment groups, CV history, geographic region and dialysis duration as fixed effects. The adjusted LS mean estimates of change from baseline to Week 24 are presented. |
| Secondary | Mean Change in Hb From Baseline to the Participant's Mean Level Between Week 28 to Week 52 in Participants With Baseline High-Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN) | Baseline (Day 1, Week 0), Week 28 to 52 | Baseline hsCRP was quantified from stored biomarker samples obtained at randomization. Baseline Hb is defined as the mean of the three last central laboratory Hb values from the screening and randomization visits. Changes in Hb from baseline to mean value during Weeks 28 to 52 in participants with baseline hsCRP \>ULN was analyzed using a MAR based multiple imputation ANCOVA. Baseline Hb was used as a covariate and treatment group, CV history, geographic region and dialysis duration as fixed effects. The adjusted LS mean estimates of change from baseline during Week 28 to Week 52 are presented. |
| Secondary | Mean Monthly IV Iron Use From Week 36 to End of Study (EOS) | Week 36 to EOS (4 weeks after the treatment period) | Oral iron supplementation was allowed for both treatment groups without restriction. Oral iron was recommended for dietary supplementation to support erythropoiesis and as the first line treatment for prevention and treatment of iron deficiency, unless the participant was intolerant to this route of treatment. In participants receiving roxadustat, the Investigator was allowed to initiate the use of an approved IV iron supplement if a participant's Hb value had not sufficiently responded to 2 or more dose increases of the IP, and ferritin \<100 nanogram per milliliter (ng/mL) or transferrin saturation (TSAT) \<20%. IP treatment was allowed to continue during IV iron administration. Discontinuation of IV iron supplementation was recommended once the participant was no longer considered to be iron deficient (ferritin \>100 ng/mL and TSAT \>20%). |
| Secondary | Time-To-First Administration of RBC Transfusion as Rescue Therapy | Baseline (Day 1, Week 0) up to EOS (4 weeks after the treatment period) | Time-to-first RBC transfusion as rescue therapy was calculated as (date of first occurrence of any RBC transfusion as rescue therapy, or date of censoring if no event had occurred) - (date of first dose of IP) + 1. Event rate was calculated as (number of participants with event) divided by (the total number of days at risk for event across all participants in given group divided by 365.25) multiplied by 100. The event rate is presented for participants with events. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 | Baseline (Day 1, Week 0), Week 28 to 52 | The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Hb From Baseline to the Mean Level During the Evaluation Period (Week 28 to Week 36) Without Having Received Rescue Therapy Within 6 Weeks Prior to and During the 8-Week Evaluation Period | Baseline (Day 1, Week 0), Week 28 to 36 | The Per Protocol Set (PPS) included all randomized participants without important protocol deviations who had received at least 8 weeks of study treatment and had valid corresponding Hb measurements. Participants from the PPS, with data available for analysis are presented. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Total Time of Hb Within the Interval of >=10 g/dL From Week 28 to Week 52 | Week 28 to 52 | The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. Participants without any Hb measurements from Week 28 were not included in the analysis. | proportion of total time | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Total Time of Hb Within the Interval of 10 to 12 g/dL From Week 28 to Week 52 | Week 28 to 52 | The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. Participants without any Hb measurements from Week 28 were not included in the analysis. | proportion of total time | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24 | Baseline (Day 1, Week 0) to Week 24 | The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. | millimole per liter | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Hb From Baseline to the Participant's Mean Level Between Week 28 to Week 52 in Participants With Baseline High-Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN) | Baseline (Day 1, Week 0), Week 28 to 52 | The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. Only participants who consented to the use of donated biomarker samples and had baseline hsCRP \>ULN were included in the analysis. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Monthly IV Iron Use From Week 36 to End of Study (EOS) | Week 36 to EOS (4 weeks after the treatment period) | The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. | milligram per month | MEAN |
| SECONDARY | Time-To-First Administration of RBC Transfusion as Rescue Therapy | Baseline (Day 1, Week 0) up to EOS (4 weeks after the treatment period) | The on-treatment+3 days safety analysis set included all participants who received at least 1 dose of randomized IP, except for those excluded from analysis. Participants were censored at 3 days after the last administration of the IP. | events per 100 participant years | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 | Roxadustat | 0.77 | Standard Error 0.041 | g/dL | |
| Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 | Epoetin Alfa | 0.68 | Standard Error 0.040 | g/dL | |
| Change in Hb From Baseline to the Mean Level During the Evaluation Period (Week 28 to Week 36) Without Having Received Rescue Therapy Within 6 Weeks Prior to and During the 8-Week Evaluation Period | Roxadustat | 0.88 | Standard Error 0.044 | g/dL | |
| Change in Hb From Baseline to the Mean Level During the Evaluation Period (Week 28 to Week 36) Without Having Received Rescue Therapy Within 6 Weeks Prior to and During the 8-Week Evaluation Period | Epoetin Alfa | 0.74 | Standard Error 0.043 | g/dL | |
| Proportion of Total Time of Hb Within the Interval of >=10 g/dL From Week 28 to Week 52 | Roxadustat | 0.79 | Standard Error 0.012 | proportion of total time | |
| Proportion of Total Time of Hb Within the Interval of >=10 g/dL From Week 28 to Week 52 | Epoetin Alfa | 0.76 | Standard Error 0.012 | proportion of total time | |
| Proportion of Total Time of Hb Within the Interval of 10 to 12 g/dL From Week 28 to Week 52 | Roxadustat | 0.65 | Standard Error 0.013 | proportion of total time | |
| Proportion of Total Time of Hb Within the Interval of 10 to 12 g/dL From Week 28 to Week 52 | Epoetin Alfa | 0.63 | Standard Error 0.012 | proportion of total time | |
| Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24 | Roxadustat | -0.38 | Standard Error 0.026 | millimole per liter | |
| Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24 | Epoetin Alfa | -0.05 | Standard Error 0.026 | millimole per liter |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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 | 1,051 | |
| Overall Study | STARTED | Epoetin Alfa | 1,055 | |
| Overall Study | Received Treatment | Roxadustat | 1,048 | |
| Overall Study | Received Treatment | Epoetin Alfa | 1,053 | |
| Overall Study | COMPLETED | Roxadustat | 982 | |
| Overall Study | COMPLETED | Epoetin Alfa | 990 | |
| Overall Study | NOT COMPLETED | Roxadustat | 69 | |
| Overall Study | NOT COMPLETED | Epoetin Alfa | 65 |
Source ClinicalTrials.gov
Adverse events1,560
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 | Diarrhoea | Gastrointestinal disorders | Roxadustat | 114 | 1,048 | 159 |
| other | Diarrhoea | Gastrointestinal disorders | Epoetin Alfa | 101 | 1,053 | 153 |
| other | Nausea | Gastrointestinal disorders | Roxadustat | 61 | 1,048 | 72 |
| other | Nausea | Gastrointestinal disorders | Epoetin Alfa | 65 | 1,053 | 94 |
| other | Vomiting | Gastrointestinal disorders | Roxadustat | 60 | 1,048 | 69 |
| other | Vomiting | Gastrointestinal disorders | Epoetin Alfa | 52 | 1,053 | 64 |
| other | Bronchitis | Infections and infestations | Roxadustat | 43 | 1,048 | 67 |
| other | Bronchitis | Infections and infestations | Epoetin Alfa | 61 | 1,053 | 95 |
| other | Upper respiratory tract infection | Infections and infestations | Roxadustat | 70 | 1,048 | 102 |
| other | Upper respiratory tract infection | Infections and infestations | Epoetin Alfa | 54 | 1,053 | 77 |
1 to 10 of 1,560Source ClinicalTrials.gov
See all 1,560 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roxadustat | 247 | 1,048 |
| Total, all-cause mortality | Epoetin Alfa | 231 | 1,053 |
| Total, other adverse events | Roxadustat | 391 | 1,048 |
| Total, other adverse events | Epoetin Alfa | 360 | 1,053 |
| Total, serious adverse events | Roxadustat | 604 | 1,048 |
| Total, serious adverse events | Epoetin Alfa | 606 | 1,053 |
Source ClinicalTrials.gov
Papers4
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 Epoetin Alfa: deaths from any cause | Trial comparisons |
| Roxadustat vs Epoetin 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/NCT02174731
GET https://conductscience.org/api/trials/v1/NCT02174731/events?page=2