Trial · NCT04076943
Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia
NCT04076943, Phase 2, Completed, Kyntra Bio; results first posted 2022-06-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia. Trials, record NCT04076943. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04076943
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia
- NCT number
- NCT04076943
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 92 participants, actual
- Lead sponsor
- Kyntra Bio
- Conditions
- Chemotherapy Induced Anemia
- Interventions
- Roxadustat
- First posted
- 2019-09-04
- Last updated
- 2022-06-03
- Results first posted
- 2022-06-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion | Baseline, up to Week 16 | Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1. All central lab assessments from Day 1 to end of treatment (EOT) or early termination (ET) were included in the evaluation of this endpoint. Hb values within 4 weeks after an RBC transfusion were excluded. |
| Secondary | Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion) | Baseline, Week 16 | Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1. Mean Hb during treatment was computed using the mean area-under-the-curve trapezoid method, from Day 1 to EOT or ET Hb assessment. |
| Secondary | Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion) | Baseline, Weeks 9, 13, and 16 | Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1. |
| Secondary | Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16 | Baseline through Week 16 | The 95% confidence interval (CI) was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded. |
| Secondary | Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16 | Baseline through Week 16 | Median was calculated using Kaplan-Meier product limit method. 95% CI was calculated using the method of Brookmeyer and Crowley. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion were excluded. |
| Secondary | Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16 | Baseline through Week 16 | The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded. |
| Secondary | Percentage of Participants Who Achieved a Hematopoietic Response | Baseline through Week 16 | Hematopoietic response was defined as an increase in Hb of 1.5 g/dL from baseline or attaining a Hb of 11 g/dL. The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded. |
| Secondary | Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From Baseline Through Week 16 | Baseline through Week 16 | The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded. |
| Secondary | Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16 | Week 5 to Week 16 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion | Baseline, up to Week 16 | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. | g/dL | MEAN |
| SECONDARY | Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion) | Baseline, Week 16 | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. | g/dL | MEAN |
| SECONDARY | Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion) | Baseline, Weeks 9, 13, and 16 | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | g/dL | MEAN |
| SECONDARY | Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16 | Baseline through Week 16 | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. | percentage of participants | NUMBER |
| SECONDARY | Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16 | Baseline through Week 16 | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. | days | MEDIAN |
| SECONDARY | Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16 | Baseline through Week 16 | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a Hematopoietic Response | Baseline through Week 16 | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From Baseline Through Week 16 | Baseline through Week 16 | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16 | Week 5 to Week 16 | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion | Roxadustat | 2.47 | Standard Deviation 1.510 | g/dL | |
| Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion) | Roxadustat | 1.20 | Standard Deviation 1.012 | g/dL | |
| Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion) | Roxadustat | Change at Week 9 | 1.43 | Standard Deviation 1.421 | g/dL |
| Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion) | Roxadustat | Change at Week 13 | 2.15 | Standard Deviation 1.921 | g/dL |
| Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion) | Roxadustat | Change at Week 16 | 2.52 | Standard Deviation 1.700 | g/dL |
| Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16 | Roxadustat | 82.0 | 95% Confidence Interval 72.5 to 89.4 | percentage of participants | |
| Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16 | Roxadustat | 41.0 | 95% Confidence Interval 29.0 to 46.0 | days | |
| Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16 | Roxadustat | 73.0 | 95% Confidence Interval 62.6 to 81.9 | percentage of participants | |
| Percentage of Participants Who Achieved a Hematopoietic Response | Roxadustat | 75.3 | 95% Confidence Interval 65.0 to 83.8 | percentage of participants | |
| Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From Baseline Through Week 16 | Roxadustat | 60.7 | 95% Confidence Interval 49.7 to 70.9 | percentage of participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Roxadustat | 92 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Roxadustat | 92 | |
| Overall Study | COMPLETED | Roxadustat | 58 | |
| Overall Study | NOT COMPLETED | Roxadustat | 34 |
Source ClinicalTrials.gov
Adverse events76
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 | Neutropenia | Blood and lymphatic system disorders | Roxadustat | 10 | 92 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Roxadustat | 10 | 92 | |
| other | Abdominal pain | Gastrointestinal disorders | Roxadustat | 6 | 92 | |
| other | Constipation | Gastrointestinal disorders | Roxadustat | 10 | 92 | |
| other | Diarrhoea | Gastrointestinal disorders | Roxadustat | 14 | 92 | |
| other | Nausea | Gastrointestinal disorders | Roxadustat | 18 | 92 | |
| other | Vomiting | Gastrointestinal disorders | Roxadustat | 12 | 92 | |
| other | Fatigue | General disorders | Roxadustat | 23 | 92 | |
| other | Oedema peripheral | General disorders | Roxadustat | 9 | 92 | |
| other | Pyrexia | General disorders | Roxadustat | 6 | 92 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roxadustat | 17 | 92 |
| Total, other adverse events | Roxadustat | 71 | 92 |
| Total, serious adverse events | Roxadustat | 40 | 92 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04076943
GET https://conductscience.org/api/trials/v1/NCT04076943/events?page=2