Trial · NCT07119372
Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
NCT07119372, Phase 3, Active not recruiting, Biocad
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis. Trials, record NCT07119372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07119372
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
- NCT number
- NCT07119372
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 228 participants, estimated
- Lead sponsor
- Biocad
- Conditions
- Anemia, Chronic Kidney Disease, Chronic Kidney Disease Patients on Hemodialysis, Chronic Kidney Disease 5D
- Interventions
- BCD-131 (pegdarbepoetin beta), Mircera (methoxypolyethylene glycol-epoetin beta)
- First posted
- 2025-08-13
- Last updated
- 2026-09-01
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 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/NCT07119372
GET https://conductscience.org/api/trials/v1/NCT07119372/registered?page=2