Trial · NCT05970172
A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
NCT05970172, Phase 3, Active not recruiting, Astellas Pharma Global Development, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease. Trials, record NCT05970172. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05970172
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
- NCT number
- NCT05970172
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 98 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Chronic Kidney Disease, Renal Anemia
- Interventions
- Roxadustat
- First posted
- 2023-08-01
- Last updated
- 2026-10-13
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in Hb level to the average Hb level over treatment weeks 20 to 24 | Baseline and weeks 20 to 24 | Mean change in Hb level between baseline and average Hb level over treatment weeks 20 to 24. |
| Secondary | Pharmacokinetics (PK) of roxadustat in plasma: Maximum concentration (Cmax) | Up to week 8 | Cmax will be recorded from the PK plasma samples collected. |
| Secondary | PK of roxadustat in plasma: Area under the plasma-concentration time curve (AUC) | Up to week 8 | AUC will be recorded from the PK plasma samples collected. |
| Secondary | PK of roxadustat in plasma: Apparent total clearance (CL/F) | Up to week 8 | CL/F will be recorded from the PK plasma samples collected. |
| Secondary | PK of roxadustat in plasma: Time of the maximum concentration (Tmax) | Up to week 8 | Tmax will be recorded from the PK plasma samples collected. |
| Secondary | Hb levels at all timepoints | Up to week 56 | Hb levels at all timepoints will be recorded. |
| Secondary | Dose titration history at all timepoints | Up to week 52 | Dose titration history at all timepoints will be recorded. |
| Secondary | Number of participants with treatment-emergent adverse events (TEAEs) | From first dose of study drug and up to week 56 | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of roxadustat, whether or not considered related to roxadustat. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of roxadustat. This includes events related to the comparator and events related to the (study) procedures. A TEAE is defined as an AE observed after starting administration of roxadustat through 28 days after the last dose of roxadustat. |
| Secondary | Number of participants with treatment-emergent cardiovascular AEs | From first dose of study drug and up to week 56 | Treatment-emergent cardiovascular AEs will be recorded. |
| Secondary | Number of participants with treatment-emergent thrombotic AEs | From first dose of study drug and up to week 56 | Treatment-emergent thrombotic AEs will be recorded. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT05970172
GET https://conductscience.org/api/trials/v1/NCT05970172/registered?page=2