Trial · NCT02273726
Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis
NCT02273726, Phase 3, Completed, Kyntra Bio; results first posted 2021-10-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis. Trials, record NCT02273726. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02273726
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis
- NCT number
- NCT02273726
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 741 participants, actual
- Lead sponsor
- Kyntra Bio
- Conditions
- CKD Anemia in Stable Dialysis Patients
- Interventions
- Epoetin Alfa, Roxadustat
- First posted
- 2014-10-24
- Last updated
- 2021-10-29
- Results first posted
- 2021-10-29
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Weeks 28 to 52), Regardless of Rescue Therapy | Baseline (Day 1, Week 0), Weeks 28 to 52 | Hb values under the influence of rescue therapy were not censored in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or red blood cell (RBC) transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb 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, Monotone missing data were imputed by regression from its own treatment group. |
| Primary | Ex-U.S. Submission: Mean Hb Change From Baseline to the Average Weeks 28 to 36, Without Having Received Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period for Participants Enrolled Under the Original Protocol | Baseline (Day 1, Week 0), Weeks 28 to 36 | Hb values under the influence of rescue therapy were censored up to 6 weeks in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. |
| Secondary | US (FDA Submission): Hb Responder Rate- Percentage of Participants With Mean Hb Level ≥10.0 g/dL Averaged Over Weeks 28 to 52, Regardless of Rescue Therapy | Weeks 28 to 52 | Hb values under the influence of rescue therapy were not censored in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. |
| Secondary | Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants With Mean Hb 10.0 to 12.0 g/dL Averaged Over Weeks 28 to 36, Censoring for Rescue Therapy | Weeks 28 to 36 | Hb values under the influence of a rescue therapy were censored up to 6 weeks in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. |
| Secondary | Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 28 | Baseline (Day 1, Week 0), Weeks 12 to 28 | Baseline LDL Cholesterol was defined as the last available value prior to the first dose of study treatment. |
| Secondary | Change From Baseline in Hb Levels Averaged Over Weeks 18 to 24 Regardless of Rescue Therapy in Participants Whose Baseline High Sensitivity C-Reactive Protein (Hs-CRP)> Upper Limit of Normal (ULN) | Baseline (Day 1, Week 0), Weeks 18 to 24 | Hb values under the influence of rescue therapy were not censored in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model, Monotone missing data were imputed by regression from its own treatment group. |
| Secondary | Average Monthly IV Iron Use Per Patient-Exposure-Month (PEM) During Weeks 28 to 52 | Weeks 28 to 52 | Monthly iron use for each participant= Total IV iron in mg / \[(last dose date - first dose date of study medication in the period)+1\]/ 28. |
| Secondary | Time to First RBC Transfusion | Baseline (Day 1, Week 0) up to last dose of study drug (maximum treatment duration was 183.7 weeks for roxadustat and 180.4 weeks for epoetin alfa) | Median time to event (weeks) was calculated using Kaplan Meier Survival Estimates. |
| Secondary | Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 20 to 28 | Baseline (Day 1, Week 0), Weeks 20 to 28 | Baseline MAP was defined as the mean of values obtained within 6 weeks prior to the first dose of study treatment. |
| Secondary | Time to First Exacerbation of Hypertension During Weeks 28 to 52 | Weeks 28 to 52 | An exacerbation of hypertension was defined as increase from baseline of ≥20 mmHg in systolic blood pressure (sBP) and sBP ≥170 mmHg or an increase from baseline of ≥15 mmHg in diastolic blood pressure (dBP) and dBP ≥100 mmHg. Median time to event (weeks) was calculated using Kaplan Meier Survival Estimates. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Weeks 28 to 52), Regardless of Rescue Therapy | Baseline (Day 1, Week 0), Weeks 28 to 52 | ITT Population included all randomized participants. | g/dL | MEAN |
| PRIMARY | Ex-U.S. Submission: Mean Hb Change From Baseline to the Average Weeks 28 to 36, Without Having Received Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period for Participants Enrolled Under the Original Protocol | Baseline (Day 1, Week 0), Weeks 28 to 36 | Per protocol set (PPS) population included all participants in full analysis set (FAS) population (all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment) who received at least 8 weeks of treatment and were without major protocol violations. 'Overall number of participants analyzed'=participants evaluable for this outcome measure. 'Number analyzed'=participants evaluable at specified timepoint. | g/dL | MEAN |
| SECONDARY | US (FDA Submission): Hb Responder Rate- Percentage of Participants With Mean Hb Level ≥10.0 g/dL Averaged Over Weeks 28 to 52, Regardless of Rescue Therapy | Weeks 28 to 52 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. | percentage of participants | NUMBER |
| SECONDARY | Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants With Mean Hb 10.0 to 12.0 g/dL Averaged Over Weeks 28 to 36, Censoring for Rescue Therapy | Weeks 28 to 36 | The PPS population included all participants in the FAS population (all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment) who received at least 8 weeks of treatment, had at least 1 valid postdose Hb assessment and were without major protocol violations. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 28 | Baseline (Day 1, Week 0), Weeks 12 to 28 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoint. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Hb Levels Averaged Over Weeks 18 to 24 Regardless of Rescue Therapy in Participants Whose Baseline High Sensitivity C-Reactive Protein (Hs-CRP)> Upper Limit of Normal (ULN) | Baseline (Day 1, Week 0), Weeks 18 to 24 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | g/dL | MEAN |
| SECONDARY | Average Monthly IV Iron Use Per Patient-Exposure-Month (PEM) During Weeks 28 to 52 | Weeks 28 to 52 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | mg/PEM | MEAN |
| SECONDARY | Time to First RBC Transfusion | Baseline (Day 1, Week 0) up to last dose of study drug (maximum treatment duration was 183.7 weeks for roxadustat and 180.4 weeks for epoetin alfa) | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. | weeks | MEDIAN |
| SECONDARY | Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 20 to 28 | Baseline (Day 1, Week 0), Weeks 20 to 28 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Time to First Exacerbation of Hypertension During Weeks 28 to 52 | Weeks 28 to 52 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. | weeks | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Weeks 28 to 52), Regardless of Rescue Therapy | Roxadustat | Baseline | 10.30 | Standard Deviation 0.661 | g/dL |
| US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Weeks 28 to 52), Regardless of Rescue Therapy | Epoetin Alfa | Baseline | 10.31 | Standard Deviation 0.656 | g/dL |
| US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Weeks 28 to 52), Regardless of Rescue Therapy | Roxadustat | Change at Weeks 28 to 52 | 0.39 | Standard Deviation 0.934 | g/dL |
| US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Weeks 28 to 52), Regardless of Rescue Therapy | Epoetin Alfa | Change at Weeks 28 to 52 | -0.09 | Standard Deviation 0.838 | g/dL |
Ex-U.S. Submission: Mean Hb Change From Baseline to the Average Weeks 28 to 36, Without Having Received Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period for Participants Enrolled Under the Original Protocol | Roxadustat | Baseline | 10.33 | Standard Deviation 0.639 | g/dL |
Ex-U.S. Submission: Mean Hb Change From Baseline to the Average Weeks 28 to 36, Without Having Received Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period for Participants Enrolled Under the Original Protocol | Epoetin Alfa | Baseline | 10.35 | Standard Deviation 0.614 | g/dL |
Ex-U.S. Submission: Mean Hb Change From Baseline to the Average Weeks 28 to 36, Without Having Received Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period for Participants Enrolled Under the Original Protocol | Roxadustat | Change at Weeks 28 to 36 | 0.54 | Standard Deviation 1.022 | g/dL |
Ex-U.S. Submission: Mean Hb Change From Baseline to the Average Weeks 28 to 36, Without Having Received Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period for Participants Enrolled Under the Original Protocol | Epoetin Alfa | Change at Weeks 28 to 36 | -0.03 | Standard Deviation 0.897 | g/dL |
| US (FDA Submission): Hb Responder Rate- Percentage of Participants With Mean Hb Level ≥10.0 g/dL Averaged Over Weeks 28 to 52, Regardless of Rescue Therapy | Roxadustat | 66.1 | percentage of participants | ||
| US (FDA Submission): Hb Responder Rate- Percentage of Participants With Mean Hb Level ≥10.0 g/dL Averaged Over Weeks 28 to 52, Regardless of Rescue Therapy | Epoetin Alfa | 58.6 | percentage of participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 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 | 370 | |
| Overall Study | STARTED | Epoetin Alfa | 371 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Roxadustat | 370 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Epoetin Alfa | 370 | |
| Overall Study | COMPLETED | Roxadustat | 127 | |
| Overall Study | COMPLETED | Epoetin Alfa | 183 | |
| Overall Study | NOT COMPLETED | Roxadustat | 243 | |
| Overall Study | NOT COMPLETED | Epoetin Alfa | 188 |
Source ClinicalTrials.gov
Adverse events1,006
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 | Anaemia | Blood and lymphatic system disorders | Roxadustat | 28 | 370 | |
| other | Anaemia | Blood and lymphatic system disorders | Epoetin Alfa | 41 | 370 | |
| other | Tachycardia | Cardiac disorders | Roxadustat | 20 | 370 | |
| other | Tachycardia | Cardiac disorders | Epoetin Alfa | 19 | 370 | |
| other | Bradycardia | Cardiac disorders | Roxadustat | 11 | 370 | |
| other | Bradycardia | Cardiac disorders | Epoetin Alfa | 19 | 370 | |
| other | Nausea | Gastrointestinal disorders | Roxadustat | 63 | 370 | |
| other | Nausea | Gastrointestinal disorders | Epoetin Alfa | 60 | 370 | |
| other | Vomiting | Gastrointestinal disorders | Roxadustat | 60 | 370 | |
| other | Vomiting | Gastrointestinal disorders | Epoetin Alfa | 55 | 370 |
1 to 10 of 1,006Source ClinicalTrials.gov
See all 1,006 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roxadustat | 70 | 370 |
| Total, all-cause mortality | Epoetin Alfa | 62 | 370 |
| Total, other adverse events | Roxadustat | 286 | 370 |
| Total, other adverse events | Epoetin Alfa | 292 | 370 |
| Total, serious adverse events | Roxadustat | 242 | 370 |
| Total, serious adverse events | Epoetin Alfa | 248 | 370 |
Source ClinicalTrials.gov
Papers3
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/NCT02273726
GET https://conductscience.org/api/trials/v1/NCT02273726/results?page=2