Trial · NCT05082584
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents
NCT05082584, Phase 3, Withdrawn, Akebia Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents. Trials, record NCT05082584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05082584
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents
- NCT number
- NCT05082584
- Status
- Withdrawn
- Phases
- Phase 3
- Enrollment
- 0 participants, actual
- Lead sponsor
- Akebia Therapeutics
- Conditions
- Anemia of Chronic Kidney Disease
- Interventions
- Vadadustat
- First posted
- 2021-10-19
- Last updated
- 2025-10-01
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Hemoglobin (Hb) Values Between Baseline and the Primary Evaluation Period (Average Hb From Weeks 21 to 28) | Baseline; Weeks 21 to 28 | |
| Secondary | Time to Achieve First Hb Levels ≥10.0 grams/deciliters (g/dL) | Up to Week 52 | |
| Secondary | Number of Participants With Mean Hb Values Within the Target Range During the Primary Evaluation Period | From Week 21 to Week 28 | |
| Secondary | Number of Participants With Mean Hb Values Within the Target Range During the Extension Period | From Week 29 to Week 52 | |
| Secondary | Number of Participants With Treatment-emergent Adverse Events and who Discontinued From the Study due to Adverse Events | Up to Week 56 | |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Vadadustat and its Metabolites | Pre-dose and post-dose at intermediate time points up to 28 weeks | |
| Secondary | Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC 0-t) of Vadadustat and its Metabolites | Pre-dose and post-dose at intermediate time points up to 28 weeks | |
| Secondary | Time to Reach Cmax (Tmax) of Vadadustat and its Metabolites | Pre-dose and post-dose at intermediate time points up to 28 weeks | |
| Secondary | Terminal Elimination Half-Life (t1/2) of Vadadustat and its Metabolites | Pre-dose and post-dose at intermediate time points up to 28 weeks | |
| Secondary | Change From Baseline in Serum Erythropoietin (EPO) | Pre-dose and post-dose at intermediate time points up to 28 weeks |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT05082584
GET https://conductscience.org/api/trials/v1/NCT05082584/registered