Trial · NCT07119372
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of subjects (%) with the target hemoglobin level (100-120 g/L inclusive) | During the assessment period at Weeks 28-32 | |
| Secondary | Proportion of subjects (%) with the target hemoglobin level (100-120 g/L inclusive) | Weeks 48-52 | |
| Secondary | Proportion of subjects (%) with a mean hemoglobin level at the time of assessment within the range of ±10 g/L from baseline | Weeks 28-32 | |
| Secondary | Proportion of subjects (%) who required dose adjustment of the test drug/reference drug during the maintenance therapy stage of the main study period | Weeks 12-32 | In the main study period, a dose adjustment is expected during the first 12 weeks of therapy (titration phase), and a maintenance therapy stage is expected during the subsequent weeks of the main study period. |
| Secondary | Proportion of subjects (%) who required dose adjustment of the test drug/reference drug during the extension study period | Weeks 33-52 | |
| Secondary | Proportion of subjects (%) who required blood transfusion during the main study period | Weeks 0-32 | |
| Secondary | Proportion of subjects (%) who required blood transfusion during the entire study | Weeks 0-52 | |
| Secondary | The mean hemoglobin level during the main study period | Weeks 0-32 | |
| Secondary | The mean hemoglobin level during the entire study | Weeks 0-52 | |
| Secondary | Proportion of subjects (%) with hemoglobin values greater than 130 g/L and with values greater than 140 g/L during the main study period | Weeks 0-32 | |
| Secondary | Proportion of subjects (%) with hemoglobin values greater than 130 g/L and with values greater than 140 g/L during the entire study | Weeks 0-52 | |
| Secondary | Proportion of subjects with reported AEs/SAEs, which, according to the investigator, are related to the study drugs | Weeks 0-32, Weeks 32-52, Weeks 52-88 | |
| Secondary | Proportion of subjects in each group who developed CTCAE v. 5.0 grade 3-4 AEs, which, in the investigator's opinion, are related to the use of the study drugs | Weeks 0-32, Weeks 32-52, Weeks 52-88 | |
| Secondary | Proportion of subjects in each group who prematurely withdrew due to AEs/SAEs | Weeks 0-32, Weeks 32-52, Weeks 52-88 | |
| Secondary | Frequency of arterial and venous thrombotic complications (cerebrovascular accident, vascular access thrombosis, etc.) | Weeks 0-32, Weeks 32-52, Weeks 52-88 | |
| Secondary | Frequency of non-fatal myocardial infarction, death from cardiovascular diseases, death from any cause | Weeks 0-32, Weeks 32-52, Weeks 52-88 | |
| Secondary | The Proportion of BAb- and NAb-positive Patients | Weeks 0, 12, 24, 36, 52, 64, 76 | Blood sampling for immunogenicity assessment (binding antibodies \[BAbs\] or neutralizing antibodies \[NAbs\]) will be performed before the first injection (Week 0) and then at Weeks 12, 24, 36, and 52 |
| Secondary | Proportion of subjects (%) with a mean hemoglobin level at the time of assessment within the range of ±10 g/L from baseline | Weeks 48-52 | |
| Other | Proportion of subjects (%) with the target hemoglobin level (100-120 g/L inclusive) | Weeks 80-84 | |
| Other | Proportion of subjects (%) who required dose adjustment of the investigational product after switching from Mircera to BCD-131 | Weeks 64-84 | The switch from Mircera to BCD-131 occurs at Week 52, followed by a 12-week titration period during which dose adjustments are expected. This titration period is excluded from the assessment of this outcome measure. |
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/NCT07119372/registered