Trial · NCT01887600
Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis
NCT01887600, Phase 3, Completed, Astellas Pharma Europe B.V.; results first posted 2020-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis. Trials, record NCT01887600. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01887600
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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 Patients Not Requiring Dialysis
- NCT number
- NCT01887600
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 594 participants, actual
- Lead sponsor
- Astellas Pharma Europe B.V.
- Conditions
- Anemia in Chronic Kidney Disease in Non-dialysis Patients
- Interventions
- Roxadustat, Placebo
- First posted
- 2013-06-27
- Last updated
- 2024-11-14
- Other registries' IDs
- eudract:2012-005180-27
- Results first posted
- 2020-12-17
Source ClinicalTrials.gov
Registered outcomes53
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Hemoglobin (Hb) Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy Prior to Hb Response | Baseline to week 24 | Hemoglobin (Hb) response was measured as Yes or No. Response Yes (responders) was defined as: Hb ≥11.0 g/dL and Hb increase from baseline by ≥ 1.0 g/dL, for participants with baseline Hb \> 8.0 g/dL; or Hb increase 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, erythropoiesis-stimulating agent (ESA), or intravenous (IV) iron prior to Hb response. This was the primary efficacy endpoint for EU (EMA). |
| Primary | Hb Change From Baseline (BL) to the Average Hb in Weeks 28-52 Regardless of Rescue Therapy | Baseline and weeks 28 to 52 | The change from baseline to the average Hb values across weeks 28 to 52 without having received rescue therapy. The Hb values from visit windows at weeks 28, 32, 36, 40, 44, 48 and 52 were used for the calculation of the average of weeks 28 to 52. This was the primary efficacy endpoint for US (FDA). |
| Secondary | Hb Change From BL to the Average Hb in Weeks 28-36 Without Having Received Rescue Therapy Within 6 Weeks Prior to and During 8-Week Evaluation Period | Baseline and weeks 28 to 36 | The Hb values from visit windows at weeks 28, 32 and 36 were used for the calculation of the average of weeks 28 to 36. |
| Secondary | Change From BL in Low-Density Lipoprotein (LDL) Cholesterol (Regardless of Fasting Status) to the Average LDL Cholesterol of Weeks 12 to 28 | Baseline and weeks 12 to 28 | Analysis was completed on all values collected on day 1 and weeks 12, 20 and 28. |
| Secondary | Time to First Use of Rescue Therapy (Composite of Red Blood Cell (RBC) Transfusions, Erythropoiesis-stimulating Agent (ESA) Use, and Intravenous (IV) Iron) | Baseline to week 104 (End of Treatment [EOT]) | The time to first use of rescue therapy was calculated (in years) as: (First event date - Analysis date of first dose intake + 1) / 365.25. The First event date was defined as Date of first dose of rescue medication during the efficacy emergent period and Analysis date of first dose intake was defined as date of first study drug dose intake collected on day 1. The Efficacy Emergent Period was defined as the evaluation period from the analysis date of first dose intake up to 7 days after the analysis date of last dose or the end of treatment (EOT) visit, whichever occurred first. Data reported was analysed by Kaplan-Meier estimate for cumulative proportion. Medication onset date was the date of the first use of rescue medication. |
| Secondary | Change From BL in Short Form (SF)-36 Vitality (VT) Sub-score to the Average VT Sub-score of Weeks 12 to 28 | Baseline and weeks 12 to 28 | Change from BL in SF-36 VT sub-score to the average value in weeks 12-28 was calculated using the physical component scores (PCS) of SF-36. The multi-purpose, short-form health survey has 36 questions with an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures. The survey measures eight dimensions or scales: (1) physical functioning (PF) (10 items); (2) role limitations due to physical health problems (RP) (3 items); (3) bodily pain (BP) (2 items); (4) social functioning (SF) (2 items); (5) general health perceptions (GH) (5 items); (6) role limitations due to emotional problems (RE) (3 items); (7) vitality, energy or fatigue (VT) (4 items); and (8) mental health (MH) (5 items). The SF-36 scores ranged from 0-100 with higher scores indicating better health status. |
| Secondary | Change From BL in SF-36 Physical Functioning (PF) Sub-score to the Average PF Sub-score of Weeks 12 to 28 | Baseline and weeks 12 to 28 | Change from baseline in SF-36 PF normalized sub-score compared to the average PF sub-score of weeks 12 to 28. The multi-purpose, short-form health survey has 36 questions with an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures. Change from baseline in PF sub score of SF-36 to the average of weeks 12-28 was compared by treatment arm for all participants (primary analysis) and in the subsets of participants with baseline PF sub score below 35 and equal or above 35. The SF-36 scores ranged from 0-100 with higher scores indicating better health status. All available SF-36 PF values were used i.e., both scheduled and unscheduled for the calculation of the average PF sub-score of weeks 12 to 28. |
| Secondary | Change From BL in Mean Arterial Pressure (MAP) to the Average MAP of Weeks 20 to 28 | Baseline and weeks 20 to 28 | The MAP was derived for each visit from the average systolic (SBP) and diastolic blood pressure (DBP) calculated for each visit using the three readings and the following equation: MAP = (2/3) \* DBP + (1/3) \* SBP. Baseline assessment was the assessment on day 1 (average of the three readings). If the baseline assessment was missing, then the latest available value prior to first drug administration was used. |
| Secondary | Time to First Occurrence of Hypertension | Baseline and year 0.5, year 1, year 1.5 and year 2 | Occurrence of hypertension was defined as SBP increase from BL ≥20 mmHg and SBP \>170 mmHg or DBP increase from BL ≥15 mmHg and DBP ≥110 mmHg. Time to first occurrence of hypertension was defined as first date where SBP criterion or DBP criterion is met, whichever occurred first. Data was analysed using Kaplan-Meier estimate for cumulative proportion. |
| Secondary | Rate of Progression of CKD Measured by Annualized Estimated Glomerular Filtration Rate (eGFR) Slope Over Time | Baseline to week 108 | Annualized eGFR slope over time was estimated by a random slopes and intercepts model using all available eGFR values (one baseline and all post-treatment values up to EOT period or start of dialysis adjusted on baseline Hb, region, CV history at baseline and the interaction terms (baseline eGFR by timepoint and baseline Hb by timepoint). All assessments collected after initiation of chronic dialysis (acute or chronic) are excluded from the analysis. Baseline assessment was the assessment from day 1 visit. If this value was missing, the value from screening visit was used. |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 registered outcomesOutcomes53
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 Hemoglobin (Hb) Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy Prior to Hb Response | Baseline to week 24 | The analysis population was the full analysis set (FAS), which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | Percentage of Participants | NUMBER |
| PRIMARY | Hb Change From Baseline (BL) to the Average Hb in Weeks 28-52 Regardless of Rescue Therapy | Baseline and weeks 28 to 52 | The analysis population was All Randomized, and it consisted of all randomized participants with available data at all time points. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Hb Change From BL to the Average Hb in Weeks 28-36 Without Having Received Rescue Therapy Within 6 Weeks Prior to and During 8-Week Evaluation Period | Baseline and weeks 28 to 36 | The analysis population was the full analysis set (FAS), which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From BL in Low-Density Lipoprotein (LDL) Cholesterol (Regardless of Fasting Status) to the Average LDL Cholesterol of Weeks 12 to 28 | Baseline and weeks 12 to 28 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Use of Rescue Therapy (Composite of Red Blood Cell (RBC) Transfusions, Erythropoiesis-stimulating Agent (ESA) Use, and Intravenous (IV) Iron) | Baseline to week 104 (End of Treatment [EOT]) | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | Percentage of participants | NUMBER |
| SECONDARY | Change From BL in Short Form (SF)-36 Vitality (VT) Sub-score to the Average VT Sub-score of Weeks 12 to 28 | Baseline and weeks 12 to 28 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From BL in SF-36 Physical Functioning (PF) Sub-score to the Average PF Sub-score of Weeks 12 to 28 | Baseline and weeks 12 to 28 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From BL in Mean Arterial Pressure (MAP) to the Average MAP of Weeks 20 to 28 | Baseline and weeks 20 to 28 | The analysis population was the per protocol set (PPS), which consisted of all FAS participants who did not meet any reasons for exclusion from the PPS and had all available data at all time points. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Occurrence of Hypertension | Baseline and year 0.5, year 1, year 1.5 and year 2 | The analysis population was the PPS, which consisted of all FAS participants who did not meet any reasons for exclusion from the PPS and had all available data at all time points. | Percentage of participants | NUMBER |
| SECONDARY | Rate of Progression of CKD Measured by Annualized Estimated Glomerular Filtration Rate (eGFR) Slope Over Time | Baseline to week 108 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | ml/min per 1.73 m^2 per year | LEAST_SQUARES_MEAN |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 outcomesResults by group510
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 Hemoglobin (Hb) Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy Prior to Hb Response | Roxadustat | 79.2 | 95% Confidence Interval 74.8 to 83.1 | Percentage of Participants | |
| Percentage of Participants With a Hemoglobin (Hb) Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy Prior to Hb Response | Placebo | 9.9 | 95% Confidence Interval 6.1 to 14.8 | Percentage of Participants | |
| Hb Change From Baseline (BL) to the Average Hb in Weeks 28-52 Regardless of Rescue Therapy | Roxadustat | 1.992 | 95% Confidence Interval 1.82 to 2.16 | g/dL | |
| Hb Change From Baseline (BL) to the Average Hb in Weeks 28-52 Regardless of Rescue Therapy | Placebo | 0.300 | 95% Confidence Interval 0.09 to 0.51 | g/dL | |
| Hb Change From BL to the Average Hb in Weeks 28-36 Without Having Received Rescue Therapy Within 6 Weeks Prior to and During 8-Week Evaluation Period | Roxadustat | 2.069 | 95% Confidence Interval 1.94 to 2.20 | g/dL | |
| Hb Change From BL to the Average Hb in Weeks 28-36 Without Having Received Rescue Therapy Within 6 Weeks Prior to and During 8-Week Evaluation Period | Placebo | 0.470 | 95% Confidence Interval 0.30 to 0.64 | g/dL | |
| Change From BL in Low-Density Lipoprotein (LDL) Cholesterol (Regardless of Fasting Status) to the Average LDL Cholesterol of Weeks 12 to 28 | Roxadustat | -0.650 | 95% Confidence Interval -0.76 to -0.54 | mmol/L | |
| Change From BL in Low-Density Lipoprotein (LDL) Cholesterol (Regardless of Fasting Status) to the Average LDL Cholesterol of Weeks 12 to 28 | Placebo | 0.051 | 95% Confidence Interval -0.08 to 0.18 | mmol/L | |
| Time to First Use of Rescue Therapy (Composite of Red Blood Cell (RBC) Transfusions, Erythropoiesis-stimulating Agent (ESA) Use, and Intravenous (IV) Iron) | Roxadustat | Year 0.5 | 6.1 | 95% Confidence Interval 3.6 to 8.7 | Percentage of participants |
| Time to First Use of Rescue Therapy (Composite of Red Blood Cell (RBC) Transfusions, Erythropoiesis-stimulating Agent (ESA) Use, and Intravenous (IV) Iron) | Placebo | Year 0.5 | 33.3 | 95% Confidence Interval 26.5 to 40.1 | Percentage of participants |
1 to 10 of 510Source ClinicalTrials.gov
See all 510 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 | 391 | |
| Overall Study | STARTED | Placebo | 203 | |
| Overall Study | Treatment Received | Roxadustat | 391 | |
| Overall Study | Treatment Received | Placebo | 203 | |
| Overall Study | COMPLETED | Roxadustat | 245 | |
| Overall Study | COMPLETED | Placebo | 89 | |
| Overall Study | NOT COMPLETED | Roxadustat | 146 | |
| Overall Study | NOT COMPLETED | Placebo | 114 |
Source ClinicalTrials.gov
Adverse events490
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 | 16 | 391 | 17 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 31 | 203 | 45 |
| other | Diarrhoea | Gastrointestinal disorders | Roxadustat | 32 | 391 | 38 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 6 | 203 | 9 |
| other | Nausea | Gastrointestinal disorders | Roxadustat | 34 | 391 | 44 |
| other | Nausea | Gastrointestinal disorders | Placebo | 6 | 203 | 6 |
| other | Asthenia | General disorders | Roxadustat | 18 | 391 | 22 |
| other | Asthenia | General disorders | Placebo | 11 | 203 | 13 |
| other | Oedema peripheral | General disorders | Roxadustat | 44 | 391 | 53 |
| other | Oedema peripheral | General disorders | Placebo | 21 | 203 | 22 |
1 to 10 of 490Source ClinicalTrials.gov
See all 490 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roxadustat | 45 | 391 |
| Total, all-cause mortality | Placebo | 20 | 203 |
| Total, other adverse events | Roxadustat | 204 | 391 |
| Total, other adverse events | Placebo | 103 | 203 |
| Total, serious adverse events | Roxadustat | 241 | 391 |
| Total, serious adverse events | Placebo | 115 | 203 |
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 Placebo: deaths from any cause | Trial comparisons |
| Roxadustat vs Placebo: 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/NCT01887600
GET https://conductscience.org/api/trials/v1/NCT01887600/registered?page=2