Anemia of Chronic Kidney DiseasePhase 3ENCASENCT06352138
Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients
A Phase 3 study testing Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration. and Active comparator: European Union licenced epoetin alfa in people with Anemia of Chronic Kidney Disease, run by Megalabs at 1 site in Uruguay.
Trial summary
Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for intravenous use, compared to Epogen®, in the treatment of anaemia in participants with chronic renal disease, dependent on… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anemia of Chronic Kidney Disease
- What is being tested?
- Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration. and Active comparator: European Union licenced epoetin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUruguay
- Study dates
- Jul 2025to Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage V Chronic kidney disease undergoing hemodialysis
Who cannot join
- Lack of consent to participate in the trial, other severe chronic disease, history of pure red cell aplasia, existence of anti erythropoietin antibodies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uruguay1 site
Megalabs
Colonia Nicolich, Departamento de Canelones, 15000
Victoria Rodriguez, MD, 26836300 ext. 3110, vrodriguez@megalabs.global
About this study
Official title: Phase III, Multicentre, Double-blind, Randomised, Parallel, Equivalence Clinical Trial to Assess Efficacy, Safety of Megalabs® Recombinant i/v Human Erythropoietin Compared to Epogen® in Anaemia in Patients With Chronic Kidney Disease
Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for intravenous use, compared to Epogen®, in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis
Read the detailed description
Patients with chronic kidney disease undergoing hemodialysis will be administered human recombinant alfa epoetin to revert anemia. Hemoglobin, hematocrit and reticulocyte counts will be assessed. Immunogenicity will be evaluated through bi-weekly Anti Drug Antibody determination. Test drug and comparator drug will be compared to evaluate biosimilarity.
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration., Active comparator: European Union licenced epoetin alfa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration.Biological
Also called Epoetin alfa Megalabs®, Human recombinant epoetin alfa
comparison vs the reference product to demonstrate biological similarity
Active comparator: European Union licenced epoetin alfaBiological
Also called Epogen®, Human recombinant epoetin alfa
comparison vs. the test product to demonstrate biological similarity
| Study group | Role | What they receive |
|---|---|---|
| Epoetin alfa Megalabs® injectable in intravenous application. | Experimental | Epoetin alfa Megalabs, Human recombinant epoetin alfa Receives: Biological: Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration. |
| Epoetin alfa Epogen® injectable in intravenous application. | Active comparator | USA licenced Epoetin alfa, Epogen®, Human recombinant epoetin alfa Receives: Biological: Active comparator: European Union licenced epoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Absolute Change in Hemoglobin Levels
Response to epoetin alfa in patients with chronic kidney failure is an increase in hematocrit, hemoglobin and reduced transfusion requirements.
Hemoglobin is the primary endpoint of the study .
Measured: 18 months
Change in Mean Hb Level
Response to epoetin alfa in patients with chronic kidney failure is an increase in hematocrit, hemoglobin and reduced transfusion requirements.
Hemoglobin is the primary endpoint of the study.
Measured: 18 months
Secondary outcomes (1)
immunogenicity
Anti-drug antibodies will be assessed in both groups every two weeks.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study startJul 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicentre, double-blind, randomised, parallel, equivalence trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Megalabs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Satish Kumar, MD, Study director, Azidus Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352138
- Sponsor's protocol ID
- ENCASE
- Acronym
- ENCASE
- Status last verified
- Aug 2024
- First submitted
- 11 Mar 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Multicentre, Double-blind, Randomised, Parallel, Equivalence Clinical Trial to Assess Efficacy, Safety of Megalabs® Recombinant i/v Human Erythropoietin Compared to Epogen® in Anaemia in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06352138
- Acronym / sponsor ID
- ENCASE / ENCASE
- Conditions
- Anemia of Chronic Kidney Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- MegalabsIndustry (pharma, biotech, devices)
- Study start
- Jul 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for intravenous use, compared to Epogen®, in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis
Detailed description
Patients with chronic kidney disease undergoing hemodialysis will be administered human recombinant alfa epoetin to revert anemia. Hemoglobin, hematocrit and reticulocyte counts will be assessed. Immunogenicity will be evaluated through bi-weekly Anti Drug Antibody determination. Test drug and comparator drug will be compared to evaluate biosimilarity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- multicentre, double-blind, randomised, parallel, equivalence trial
| Arm | Type | Receives |
|---|---|---|
| Epoetin alfa Megalabs® injectable in intravenous application. | Experimental | Biological: Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration.Epoetin alfa Megalabs, Human recombinant epoetin alfa |
| Epoetin alfa Epogen® injectable in intravenous application. | Active comparator | Biological: Active comparator: European Union licenced epoetin alfaUSA licenced Epoetin alfa, Epogen®, Human recombinant epoetin alfa |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stage V Chronic kidney disease undergoing hemodialysis
Key exclusion criteria (1 listed)
- Lack of consent to participate in the trial, other severe chronic disease, history of pure red cell aplasia, existence of anti erythropoietin antibodies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration.Also: Epoetin alfa Megalabs®, Human recombinant epoetin alfacomparison vs the reference product to demonstrate biological similarity | Biological | Epoetin alfa Megalabs® injectable in intravenous application. |
| Active comparator: European Union licenced epoetin alfaAlso: Epogen®, Human recombinant epoetin alfacomparison vs. the test product to demonstrate biological similarity | Biological | Epoetin alfa Epogen® injectable in intravenous application. |
Primary outcome
Mean Absolute Change in Hemoglobin Levels
Time frame: 18 months
Response to epoetin alfa in patients with chronic kidney failure is an increase in hematocrit, hemoglobin and reduced transfusion requirements. Hemoglobin is the primary endpoint of the study .
Change in Mean Hb Level
Time frame: 18 months
Response to epoetin alfa in patients with chronic kidney failure is an increase in hematocrit, hemoglobin and reduced transfusion requirements. Hemoglobin is the primary endpoint of the study.
1 secondary outcome
immunogenicity
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- reference guidelineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Satish Kumar, MD study director
Azidus Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration. and Active comparator: European Union licenced epoetin alfa in people with Anemia of Chronic Kidney Disease, run by Megalabs at 1 site in Uruguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uruguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcos Giusti, MD (59826838000, mgiusti@megalabs.global), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Absolute Change in Hemoglobin Levels (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.