A Phase 3 interventional study of Erythropoietin alfa in Anemia of Chronic Kidney Disease, sponsored by Bio Sidus SA. Completed at 11 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Bio Sidus SA · Phase 3, Interventional, and Treatment
Phase III, multicenter, randomized, open, controlled clinical trial. A study designed as phase III, in 120 patients with chronic renal failure in the pre-dialysis stage, evaluate efficacy and safety of Hemax PFS® (PFS: prefilled syringes) vs the innovator erythropoietin alfa product (Eprex®).
This was a Phase IIIB, multicenter, randomized, open-label study to compare two products with epoetin alfa (HEMAX® PFS versus EPREX/ERYPO®).
This trial was open-label for both the patient and the investigator, but blinded in the performance of laboratory analyses.
The overall objective of the study was to evaluate the efficacy and the safety of HEMAX® PFS compared to EPREX/ERYPO®, following a dose-titration and maintenance scheme similar to the one used in the regular clinical practice.
All patients received HEMAX® PFS or EPREX/ERYPO® twice a week subcutaneously during 12 weeks of titration, switching then to an equivalent weekly dose during 12 additional maintenance weeks. During the dosing scheme switch from twice a week to once weekly, each patient continued receiving the treatment assigned at randomization.
The study conclude with n=43 patients.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's enrollment of 43 is below the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →Bio Sidus SA is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receive EPREX/ ERYPO® subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below. There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Biological: Erythropoietin alfa
receive HEMAX® PFS subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below. There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.
Biological: Erythropoietin alfa
Prefilled syringes of erythropoietin
Efficacy Evaluation Through Change in Hemoglobin Levels
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®.
Time frame: 12 weeks of treatment
Adverse Events and Adverse Reactions (Safety and Tolerability) at Weeks 12 and 24.
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®.
Time frame: 24 weeks of treatment
Percentage of Responder Patients
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®.
Time frame: 12 weeks of treatment
Percentage of Patients That Required Any Transfusion
Evaluate the percentage of transfusional requirements after 12 weeks of treatment, comparing patients treated with HEMAX PFS versus those treated with EPREX/ ERYPO®.
Time frame: 12 weeks of treatment
Change of Hemoglobin Level at Week 12 of Treatment
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.
Time frame: Intragroup efficacy until week 12
Evaluate the Efficacy Between Arms 24 Weeks: Week Doses in the Titration
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
Time frame: Intragroup efficacy until week 24
Incidence of Anti-drug Antibodies (Immunogenicity)
An anti-erythropoietin alfa antibody determination will be performed to evaluate treatment immunogenicity at week 12 and 24 visit
Time frame: 12 and 24 weeks of treatment
Concentration of Hepcidin
Hepcidin will be analyzed by ELISA at baseline, week 12 and 24 in order to evaluate the treatment response.
Time frame: 24 weeks of treatment
| Milestone | Eprex/Erypo | Hemax PFS |
|---|---|---|
| Started | 20 | 23 |
| Completed | 16 | 20 |
| Not completed | 4 | 3 |
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®.
| Hemoglobin levels (g/dL) | Eprex/Erypo | Hemax PFS |
|---|---|---|
| Baseline hemoglobin levels | 9.56 ± 0.60 | 9.44 ± 0.81 |
| Average hemoglobin levels between visits 8 and 12 | 11.05 ± 0.74 | 11.11 ± 1.11 |
| Hemoglobin levels change between both times | 1.49 ± 0.99 | 1.66 ± 1.05 |
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®.
| Adverse Events | Eprex/Erypo | Hemax PFS |
|---|---|---|
| Overall Adverse Events | 23 | 30 |
| Serious Events | 4 | 4 |
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®.
| percentage of participants | Eprex/Erypo | Hemax PFS |
|---|---|---|
| Non-Responders | 5.56 | 4.55 |
| Responders | 94.44 | 95.45 |
Evaluate the percentage of transfusional requirements after 12 weeks of treatment, comparing patients treated with HEMAX PFS versus those treated with EPREX/ ERYPO®.
| Percentage of patients | Eprex/Erypo | Hemax PFS |
|---|---|---|
| Percentage of Patients That Required Any Transfusion | 5 | 0 |
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.
| Hemoglobin levels (g/dL) | Eprex/Erypo | Hemax PFS |
|---|---|---|
| Baseline | 9.56 ± 0.60 | 9.44 ± 0.81 |
| Week 8 to 12 | 11.05 ± 0.74 | 11.11 ± 1.11 |
| Change | 1.49 ± 0.99 | 1.66 ± 1.05 |
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
| Hemoglobin levels (g/dL) | Eprex/Erypo | Hemax PFS |
|---|---|---|
| Week 12 | 11.08 ± 0.9 | 11.16 ± 0.8 |
| Week 16 | 10.9 ± 0.97 | 10.82 ± 1.12 |
| Week 20 | 10.51 ± 0.90 | 10.71 ± 1.09 |
| Week 24 | 10.97 ± 0.96 | 10.85 ± 1.44 |
An anti-erythropoietin alfa antibody determination will be performed to evaluate treatment immunogenicity at week 12 and 24 visit
| Participants with positive result | Eprex/Erypo | Hemax PFS |
|---|---|---|
| Week 12 | 0 | 0 |
| Week 24 | 0 | 1 |
Hepcidin will be analyzed by ELISA at baseline, week 12 and 24 in order to evaluate the treatment response.
| ng hepcidin/ml | Eprex/Erypo | Hemax PFS |
|---|---|---|
| Baseline | 84.80 ± 67.67 | 74.21 ± 64.26 |
| Week 12 | 107.80 ± 96.31 | 56.07 ± 55.62 |
| Week 24 | 83.60 ± 58.29 | 60.93 ± 44.16 |
Collected over After 12 and 24 weeks of treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Eprex/Erypo | 1/20 (5%) | 4/20 (20%) | 8/20 (40%) |
| Hemax PFS | 0/23 (0%) | 3/23 (13%) | 5/23 (21.7%) |
| Event | Eprex/Erypo | Hemax PFS |
|---|---|---|
| Urinary tract infectionRenal and urinary disorders | 0/20 | 2/23 |
| SepsisInfections and infestations | 1/20 | 0/23 |
| Gastrointestinal angiodysplasiaGastrointestinal disorders | 1/20 | 0/23 |
| Worsening of renal functionRenal and urinary disorders | 1/20 | 0/23 |
| Worsened conditionGeneral disorders | 1/20 | 0/23 |
| Foot ulcerVascular disorders | 0/20 | 1/23 |
| Event | Eprex/Erypo | Hemax PFS |
|---|---|---|
| Increased blood pressureCardiac disorders | 3/20 | 3/23 |
| Lower limb edemaCardiac disorders | 0/20 | 2/23 |
| Increased lipidsMetabolism and nutrition disorders | 0/20 | 2/23 |
| Acute bronchitisInfections and infestations | 0/20 | 2/23 |
| HypervolemiaCardiac disorders | 1/20 | 0/23 |
| HypotensionCardiac disorders | 1/20 | 0/23 |
| Acute diarrheaGastrointestinal disorders | 1/20 | 0/23 |
| DyspepsiaGastrointestinal disorders | 1/20 | 0/23 |
| SplenomegalyBlood and lymphatic system disorders | 1/20 | 0/23 |
| Increased creatinine levelsMetabolism and nutrition disorders | 1/20 | 0/23 |
| Age, Categorical(Participants) | Eprex/Erypo | Hemax PFS | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 23 | 43 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Eprex/Erypo | Hemax PFS | Total |
|---|---|---|---|
| Median | 60.5 (20 to 80) | 64 (18 to 83) | 61 (18 to 83) |
| Sex: Female, Male(Participants) | Eprex/Erypo | Hemax PFS | Total |
|---|---|---|---|
| Female | 15 | 17 | 32 |
| Male | 5 | 6 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Eprex/Erypo | Hemax PFS | Total |
|---|---|---|---|
| Hispanic or Latino | 20 | 23 | 43 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Eprex/Erypo | Hemax PFS | Total |
|---|---|---|---|
| Argentina | 17 | 22 | 39 |
| Paraguay | 3 | 1 | 4 |
| Hemoglobin blood level(g/dL) | Eprex/Erypo | Hemax PFS | Total |
|---|---|---|---|
| Mean | 9.56 ± 0.60 | 9.44 ± 0.81 | 9.50 ± 0.72 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Epoetin Alfa
Bio Sidus SA