Trial · NCT04036253

Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease

NCT04036253, Phase 3, Completed, Bio Sidus SA; results first posted 2025-03-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease. Trials, record NCT04036253. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04036253

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease
NCT number: NCT04036253
Status: Completed
Phases: Phase 3
Enrollment: 43 participants, actual
Lead sponsor: Bio Sidus SA
Conditions: Anemia of Chronic Kidney Disease
Interventions: Erythropoietin alfa
First posted: 2019-07-29
Last updated: 2025-03-20
Results first posted: 2025-03-20

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Efficacy Evaluation Through Change in Hemoglobin Levels	12 weeks of treatment	Evaluate the efficacy of treatment with erythropoietin alfa through the measured changes in levels of hemoglobin from baseline value to the mean value of the 8 to 12 weeks of treatment, comparing patients treated with HEMAX® PFS versus EPREX/ ERYPO®.
Primary	Adverse Events and Adverse Reactions (Safety and Tolerability) at Weeks 12 and 24.	24 weeks of treatment	Evaluate the safety through the incidence of adverse events and adverse reactions asessed after 12 and 24 weeks of treatment (week 24 reported which includes those evaluated at week 12), comparing patients treated with HEMAX® PFS versus those treated with EPREX/ ERYPO®.
Secondary	Percentage of Responder Patients	12 weeks of treatment	Evaluate the efficacy of treatment with erythropoietin alfa through the percentage of responder patients (increase of Hb ≥ 1g/ dl) after 12 weeks of treatment, comparing patients treated with HEMAX® PFS versus those treated with EPREX/ ERYPO®.
Secondary	Percentage of Patients That Required Any Transfusion	12 weeks of treatment	Evaluate the percentage of transfusional requirements after 12 weeks of treatment, comparing patients treated with HEMAX PFS versus those treated with EPREX/ ERYPO®.
Secondary	Change of Hemoglobin Level at Week 12 of Treatment	Intragroup efficacy until week 12	Evaluate the efficacy between arms (HEMAX® PFS and EPREX/ ERYPO®) of treatment with erythropoietin alfa through the change in the level of hemoglobin from baseline in every visit until the week 12 visit.
Secondary	Evaluate the Efficacy Between Arms 24 Weeks: Week Doses in the Titration	Intragroup efficacy until week 24	Evaluate the efficacy between arms (HEMAX® PFS and EPREX/ ERYPO®) of the change from the twice - a - week doses in the titration phase to a weekly dose in the maintenance phase through the changes in the hemoglobin levels from week 12 to weeks 16, 20 and 24 of treatment
Secondary	Incidence of Anti-drug Antibodies (Immunogenicity)	12 and 24 weeks of treatment	An anti-erythropoietin alfa antibody determination will be performed to evaluate treatment immunogenicity at week 12 and 24 visit
Secondary	Concentration of Hepcidin	24 weeks of treatment	Hepcidin will be analyzed by ELISA at baseline, week 12 and 24 in order to evaluate the treatment response.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Efficacy Evaluation Through Change in Hemoglobin Levels	12 weeks of treatment	Per protocol analysis	Hemoglobin levels (g/dL)	MEAN
PRIMARY	Adverse Events and Adverse Reactions (Safety and Tolerability) at Weeks 12 and 24.	24 weeks of treatment		Adverse Events	NUMBER
SECONDARY	Percentage of Responder Patients	12 weeks of treatment	Patients were classified as non-responders when hemoglobin did not increase at least 1 g/dL regarding baseline during any of the first 12 weeks of treatment	percentage of participants	NUMBER
SECONDARY	Percentage of Patients That Required Any Transfusion	12 weeks of treatment		Percentage of patients	NUMBER
SECONDARY	Change of Hemoglobin Level at Week 12 of Treatment	Intragroup efficacy until week 12		Hemoglobin levels (g/dL)	MEAN
SECONDARY	Evaluate the Efficacy Between Arms 24 Weeks: Week Doses in the Titration	Intragroup efficacy until week 24		Hemoglobin levels (g/dL)	MEAN
SECONDARY	Incidence of Anti-drug Antibodies (Immunogenicity)	12 and 24 weeks of treatment		Participants with positive result	NUMBER
SECONDARY	Concentration of Hepcidin	24 weeks of treatment	The analysis was restricted to patients with available hepcidin samples at baseline, 12 weeks, and 24 weeks due to an unanticipated loss of samples.	ng hepcidin/ml	MEAN

Source ClinicalTrials.gov

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Efficacy Evaluation Through Change in Hemoglobin Levels	Eprex/Erypo	Baseline hemoglobin levels	9.56	Standard Deviation 0.60	Hemoglobin levels (g/dL)
Efficacy Evaluation Through Change in Hemoglobin Levels	Hemax PFS	Baseline hemoglobin levels	9.44	Standard Deviation 0.81	Hemoglobin levels (g/dL)
Efficacy Evaluation Through Change in Hemoglobin Levels	Eprex/Erypo	Average hemoglobin levels between visits 8 and 12	11.05	Standard Deviation 0.74	Hemoglobin levels (g/dL)
Efficacy Evaluation Through Change in Hemoglobin Levels	Hemax PFS	Average hemoglobin levels between visits 8 and 12	11.11	Standard Deviation 1.11	Hemoglobin levels (g/dL)
Efficacy Evaluation Through Change in Hemoglobin Levels	Eprex/Erypo	Hemoglobin levels change between both times	1.49	Standard Deviation 0.99	Hemoglobin levels (g/dL)
Efficacy Evaluation Through Change in Hemoglobin Levels	Hemax PFS	Hemoglobin levels change between both times	1.66	Standard Deviation 1.05	Hemoglobin levels (g/dL)
Adverse Events and Adverse Reactions (Safety and Tolerability) at Weeks 12 and 24.	Eprex/Erypo	Overall Adverse Events	23		Adverse Events
Adverse Events and Adverse Reactions (Safety and Tolerability) at Weeks 12 and 24.	Hemax PFS	Overall Adverse Events	30		Adverse Events
Adverse Events and Adverse Reactions (Safety and Tolerability) at Weeks 12 and 24.	Eprex/Erypo	Serious Events	4		Adverse Events
Adverse Events and Adverse Reactions (Safety and Tolerability) at Weeks 12 and 24.	Hemax PFS	Serious Events	4		Adverse Events

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Eprex/Erypo	20
Overall Study	STARTED	Hemax PFS	23
Overall Study	COMPLETED	Eprex/Erypo	16
Overall Study	COMPLETED	Hemax PFS	20
Overall Study	NOT COMPLETED	Eprex/Erypo	4
Overall Study	NOT COMPLETED	Hemax PFS	3

Source ClinicalTrials.gov

Adverse events76

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Increased blood pressure	Cardiac disorders	Eprex/Erypo	3	20	3
other	Increased blood pressure	Cardiac disorders	Hemax PFS	3	23	3
other	Lower limb edema	Cardiac disorders	Eprex/Erypo	0	20	0
other	Lower limb edema	Cardiac disorders	Hemax PFS	2	23	2
other	Hypervolemia	Cardiac disorders	Eprex/Erypo	1	20	1
other	Hypervolemia	Cardiac disorders	Hemax PFS	0	23	0
other	Hypotension	Cardiac disorders	Eprex/Erypo	1	20	1
other	Hypotension	Cardiac disorders	Hemax PFS	0	23	0
other	Acute diarrhea	Gastrointestinal disorders	Eprex/Erypo	1	20	1
other	Acute diarrhea	Gastrointestinal disorders	Hemax PFS	0	23	0

1 to 10 of 76Source ClinicalTrials.gov

See all 76 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Eprex/Erypo	1	20
Total, all-cause mortality	Hemax PFS	0	23
Total, other adverse events	Eprex/Erypo	8	20
Total, other adverse events	Hemax PFS	5	23
Total, serious adverse events	Eprex/Erypo	4	20
Total, serious adverse events	Hemax PFS	3	23

Source ClinicalTrials.gov

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Eprex/Erypo vs Hemax PFS: deaths from any cause	Trial comparisons
Eprex/Erypo vs Hemax PFS: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04036253

GET https://conductscience.org/api/trials/v1/NCT04036253/results?page=2

API reference For AI assistants