Trial · NCT05970172
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| 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. |
| Secondary | Number of participants with laboratory value abnormalities and/or AEs | Up to week 52 | Number of participants with potentially clinically significant laboratory values. |
| Secondary | Number of participants with vital sign abnormalities and/or AEs | Up to week 52 | Number of participants with potentially clinically significant vital sign values. |
| Secondary | Change from baseline in growth parameter value: Height | Baseline and up to week 52 | Height will be recorded at all timepoints. |
| Secondary | Change from baseline in growth parameter value: Weight | Baseline and up to week 52 | Weight will be recorded at all timepoints. |
| Secondary | Number of participants with physical examinations abnormalities and/or AEs | Up to week 52 | Number of participants with potentially clinically significant physical examination abnormalities. |
| Secondary | Percentage of participants with Hb response | Up to Week 24 | Response is defined as a participant achieving 2 consecutive Hb values within 1 g/dL of baseline (ESA-treated participants only) or achieving the target range of 10.0 to 12.0 g/dL at the end of the 24-week treatment evaluation period (i.e., weeks 20 to 24) without having received rescue therapy within 6 weeks prior to or during this 4-week evaluation period. |
| Secondary | Mean monthly intravenous (IV) iron use | Up to week 52 | Summaries of monthly IV iron usage (number of administrations) will be recorded. |
| Secondary | Mean Monthly total IV iron dosage | Up to week 52 | Summaries of monthly IV iron usage (total dosage) will be recorded. |
| Secondary | Percentage of participants using IV iron | Up to week 52 | Percentage of participants using IV iron by study period will be recorded. |
| Secondary | Percentage of participants using oral iron | Up to week 52 | Percentage of participants using oral iron by study period will be recorded. |
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/NCT05970172/registered