Trial · NCT04410198
Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants
NCT04410198, Phase 3, Completed, Kyntra Bio; results first posted 2022-09-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants. Trials, record NCT04410198. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04410198
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants
- NCT number
- NCT04410198
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 203 participants, actual
- Lead sponsor
- Kyntra Bio
- Conditions
- Anemia Associated With End Stage Renal Disease (ESRD)
- Interventions
- Roxadustat
- First posted
- 2020-06-01
- Last updated
- 2022-09-13
- Results first posted
- 2022-09-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Mean Hb Value ≥10 g/dL | Week 16 through Week 24 | Percentage of participants with mean Hb value ≥10 g/dL, averaged from Week 16 through Week 24 has been reported. 95% confidence interval (CI) was calculated based on the normal approximation to the binomial distribution. |
| Primary | Mean Hb Change From Baseline to Average Hb From Weeks 16-24 | Baseline, Weeks 16-24 | Baseline Hb was defined as the mean of available central laboratory Hb values prior to first dose of study medication including the predose Hb value collected on Day 1. Missing data was imputed using Monte Carlo Markov Chain (MCMC) imputation model. |
Source ClinicalTrials.gov
Outcomes2
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 Mean Hb Value ≥10 g/dL | Week 16 through Week 24 | The full analysis set included all enrolled participants who provided baseline Hb data and data for at least 1 postbaseline Hb time point. | percentage of participants | NUMBER |
| PRIMARY | Mean Hb Change From Baseline to Average Hb From Weeks 16-24 | Baseline, Weeks 16-24 | The full analysis set included all enrolled participants who provided baseline Hb data and data for at least 1 postbaseline Hb time point. | g/dL | MEAN |
Source ClinicalTrials.gov
Results by group2
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 Mean Hb Value ≥10 g/dL | Roxadustat | 84.7 | 95% Confidence Interval 79.1 to 90.2 | percentage of participants | |
| Mean Hb Change From Baseline to Average Hb From Weeks 16-24 | Roxadustat | 0.46 | Standard Deviation 1.007 | g/dL |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Roxadustat | 203 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Roxadustat | 203 | |
| Overall Study | Full Analysis Set | Roxadustat | 201 | |
| Overall Study | COMPLETED | Roxadustat | 166 | |
| Overall Study | NOT COMPLETED | Roxadustat | 37 |
Source ClinicalTrials.gov
Adverse events91
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 | 15 | 203 | |
| other | COVID-19 | Infections and infestations | Roxadustat | 11 | 203 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Roxadustat | 12 | 203 | |
| serious | Blood loss anaemia | Blood and lymphatic system disorders | Roxadustat | 1 | 203 | |
| serious | Leukocytosis | Blood and lymphatic system disorders | Roxadustat | 1 | 203 | |
| serious | Acute myocardial infarction | Cardiac disorders | Roxadustat | 4 | 203 | |
| serious | Cardiac arrest | Cardiac disorders | Roxadustat | 3 | 203 | |
| serious | Angina pectoris | Cardiac disorders | Roxadustat | 1 | 203 | |
| serious | Angina unstable | Cardiac disorders | Roxadustat | 1 | 203 | |
| serious | Atrial fibrillation | Cardiac disorders | Roxadustat | 1 | 203 |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roxadustat | 10 | 203 |
| Total, other adverse events | Roxadustat | 34 | 203 |
| Total, serious adverse events | Roxadustat | 52 | 203 |
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/NCT04410198
GET https://conductscience.org/api/trials/v1/NCT04410198/events?page=2