Trial · NCT05585645
A Study to Compare Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis (CKD)
NCT05585645, Phase 3, Completed, Nanogen Pharmaceutical Biotechnology Joint Stock Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Compare Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis (CKD). Trials, record NCT05585645. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05585645
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis (CKD)
- NCT number
- NCT05585645
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 214 participants, actual
- Lead sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock Company
- Conditions
- Anemia, Chronic Kidney Disease Requiring Chronic Dialysis
- Interventions
- Stimus (NNG-DEPO)
- First posted
- 2022-10-19
- Last updated
- 2026-08-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The mean change Hemoglobin level from baseline to Week 24 | Week 0 (Assessed predose)- Week 24 | |
| Secondary | Proportion of patients achieving 1 g/dL rise in Hb from baseline during 24 weeks after treatment | Week 0 (Assessed predose)- Week 24 | |
| Secondary | Proportion of patients achieving Hb within the target range (10 - 12 g/dL) at week 24. | Week 24 | |
| Secondary | Proportion of patients need for blood transfusion during 24 weeks after treatment. | Week 0 (Assessed predose)- Week 24 | |
| Secondary | 4. The mean dose of NNG-DEPO/Aranesp administered for achievement of Hb in the target Hb levels (10 - 12 g/dL) during 24 weeks. | Week 0 (Assessed predose)- Week 24 | |
| Secondary | Time to initial achievement of Hb ≥ 11 g/dL. | Week 0 (Assessed predose)- Week 24 | |
| Secondary | Proportion of the adverse events (AE) including physical examinations, vital signs, and clinical laboratory investigations. | Week 0 (Assessed predose)- Week 24 | |
| Secondary | Proportion of patients positive with anti-Darbepoetin alfa antibody after treatment. | Week 0 (Assessed predose)- Week 24 |
Source ClinicalTrials.gov
Outcomes0
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/NCT05585645
GET https://conductscience.org/api/trials/v1/NCT05585645/registered