Trial · NCT04155125
A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient
NCT04155125, Phase 3, Completed, PT Kalbe Genexine Biologics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient. Trials, record NCT04155125. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04155125
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient
- NCT number
- NCT04155125
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 391 participants, actual
- Lead sponsor
- PT Kalbe Genexine Biologics
- Conditions
- Anaemia Associated With Chronic Kidney Disease
- Interventions
- efepoetin alfa, Mircera
- First posted
- 2019-11-07
- Last updated
- 2023-12-22
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the efficacy of efepoetin alfa in the treatment of anaemia associated with CKD as measured by haemoglobin (Hb) response rate at the end of correction treatment evaluation period | Measurement from the date of Randomization till the End of the Corrective Treatment period, assessed up to 20 weeks. | Measurement is done by an increase in Hb more than or equal to 1 g/dL compared with baseline and a Hb concentration within range of 10 - 12 g/dL inclusive without transfusion during evaluation period |
| Secondary | Characterise safety and tolerability of subcutaneous efepoetin alfa is being measured by based on the frequency of adverse events and on the number of out of range laboratory values. | Measurement from the time the subject provides informed consent through and including 28 calendar days after the last study drug administration. | Safety endpoints parameters including Serious Adverse Events (SAE) specified below 1. Composite outcome of cardiovascular death or a nonfatal myocardial infarction or stroke 2. All-cause mortality 3. Cardiovascular mortality 4. Acute myocardial infarction 5. Heart failure 6. Acute kidney injury defined according to Acute Kidney Injury Network (AKIN) criteria 7. Abnormal clinical laboratory tests (haematology, biochemistry including serum ferritin and TSAT) 8. Anti-efepoetin alfa or anti-Mircera antibody titres 9. Clinically meaningful abnormal findings of vital signs 10. Development of clinically meaningful electrocardiogram abnormalities 11. Hospitalisations (excluding those for logistic reasons) It is a composite outcome. Any abnormal test findings during the study will be helpful in reviewing the outcome. |
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/NCT04155125
GET https://conductscience.org/api/trials/v1/NCT04155125/registered