Trial · NCT03054337
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 26 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Number of the Participants With the Indicated Number of Dose Adjustments From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline to Week 16 | Increases in dose were not allowed during the 6-week Primary Efficacy Period. |
| Secondary | Number of Participants Who Maintained Iron Sufficiency From Baseline to Week 6 | Baseline to Week 6 | Iron sufficiency was defined as ferritin ≥50 ng/mL and TSAT ≥20%. |
| Secondary | Number of Participants Who Maintained Iron Sufficiency From Baseline to Week 16 | Baseline to Week 16 | Iron sufficiency was defined as ferritin ≥50 ng/mL and TSAT ≥20%. |
| Secondary | Plasma Concentration Profile of Vadadustat and Its Metabolites Using a Pre-dose Sample From Week 4 | Week 4, pre-dose | Blood samples were collected for analysis. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) in the Primary Efficacy Period | up to Week 6 | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. An AE that met one or more of the following criteria or outcomes was classified as serious: death; life-threatening; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/ incapacity; congenital anomaly/birth defect; was considered a medically important event not meeting the above criteria, but which could jeopardize a participant, or could require medical or surgical intervention to prevent one of the criteria listed in this definition. |
| Secondary | Number of Participants With TEAEs and Treatment-emergent SAEs in the Dose Adjustment and Maintenance Period | up to Week 16 | An AE was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. An AE that met one or more of the following criteria or outcomes was classified as serious: death; life-threatening; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; was considered a medically important event not meeting the above criteria, but which could jeopardize a participant, or could require medical or surgical intervention to prevent one of the criteria listed in this definition. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03054337/registered?page=2