Chronic Kidney DiseasePhase 3NCT01695759

Clinical Efficacy of Two Erythropoietin Drug in Participants With Secondary Anemia to Chronic Kidney Disease.

A Phase 3 study testing Epoetin alpha and Eprex in people with Chronic Kidney Disease and Anemia, run by Azidus Brasil at 10 sites in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a prospective, randomized, multicenter, parallel, placebo-controlled, phase III study for evaluation of clinical efficacy and immunogenicity of drug Eritromax® - (rHuEPO Blau Farmacêutica S/A.) compared to Eprex® (Janssen-Cilag rHuEPO) for the treatment of patients with secondary anemia to chronic kidney… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Kidney Disease, Anemia
What is being tested?: Epoetin alpha and Eprex
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 10 sitesBrazil
Study dates: Dec 2013to Jan 2018
Phase: Phase 3
Are there results?: None posted in the registry

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntary participation and agree to all the purposes of the study by signing and dating ICF;
Male or female participantes, regardless of race or social class;
Participants aged ≥18 and ≤70 years;
Bearer dialysis-dependent CKD (hemodialysis and peritoneal dialysis *);
Clinical diagnosis of anemia, characterized as hemoglobin levels <10g/dL before the start of the study;
Adequate dialysis: Kt / V ≥ 1.2 for hemodialysis patients (based on the calculation of Daugirdas II) and ≥ 1.7 for patients on peritoneal dialysis;
Adequate iron stores (TSAT> 20% and serum ferritin> 100ng/ml) prior to initiation of treatment with erythropoietin.

Who cannot join

Participation in clinical trials in the 12 months preceding the survey;
Patients with uncontrolled hypertension, with mean above 180/100mmHg and whose requiring hospitalization in the last 6 months;
Presence of other causes of anemia than CKD, such as bleeding, hemolysis, pernicious anemia and hemoglobinopathies;
Patients who present changes or clinical abnormalities, qualified as interfering changes, such as severe hyperparathyroidism (iPTH> 1000 pg / mL), severe congestive heart failure (NYHA Class IV), acute myocardial infarction within the last 3 months, or active neoplasia in follow-up, severe liver disease, active infection (leukocyte changes), history of aluminum toxicity or scheduled surgery, pregnancy or lactation;
Patients who have a known hypersensitivity to any component of the formulation and to products derived from mammalian cells;
Prior therapies with erythropoietin for less than 3 months;
Realization transfusion for less than 3 months;
Any situation at the discretion of the Principal Investigator interfere with study data.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Brazil10 sites

Fundação Universitária de Caxias do Sul - Instituto de Pesquisa Clínica para Estudos Multicêntricos
Caxias do Sul, Rio Grande do Sul, 95070-561
Instituto Scribner de Ensino, Pesquisa, Ciência e Tecnologia
Curitiba, Paraná
Clínica Senhor do Bomfim Ltda
Feira de Santana, Estado de Bahia, 44001-584
Fundação Pró-Rim
Joinville, Santa Catarina
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul
União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul
Hospital de Ensino Padre Anchieta
São Bernardo do Campo, São Paulo
CMIN - Clínica De Medicina Interna E Nefrologia
São Paulo, 05001-000
Fundação Oswaldo Cruz (Hospital do Rim e Hipertensão)
São Paulo
Real e Benemérita Associação Portuguesa de Beneficência São Paulo (Hospital Beneficência Portuguesa)
São Paulo

Other trials in Brazil

About this study

Official title: Evaluation of Clinical Efficacy and Immunogenicity of Drug Eritromax® at Blau Farmacêutica S.A. Compared to Eprex®, Produced by Janssen-Cilag Laboratory in Participants With Secondary Anemia to Chronic Kidney Disease.

Read the detailed description

This is a phase III study, in which participants with secondary anemia to chronic kidney disease will receive two subcutaneous injection of 50 UI/Kg of the investigational product (Eritromax®) or Eprex® per week. After four weeks of treatment, the dose of drugs will be change by clinical judged throughout study according to laboratory results. The evidence of efficacy will be evaluated by hemoglobin levels alteration throughout the correction phase (first four weeks). Secondary efficacy and safety endpoints will be assessed by: maintenance of hemoglobin levels (baseline vs. end of treatment) over maintenance phase; dose of EPO required during correction and maintenance phase; Transfusion needs; report of adverse events (including type, frequency, intensity, serioussness, severity and relation to the investigation product) throughouht 12 months of follow-up. Additionally, the immunological response of products over study will be evaluated by quantification of anti-erythropoietin every six months.

Conditions: Chronic Kidney Disease, Anemia
Being tested: Epoetin alpha, Eprex
Keywords: Anemia Secondary, Chronic Kidney Disease
Medical subject headings: Renal Insufficiency, Chronic, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Epoetin alphaDrug
Participants assigned to this arm will receive two subcutaneous administrations per week of 50 UI/kg of Epoetin alpha (Eritromax), totaling 100 UI/kg/week. After the first four weeks of treatment, once a month throughout the study the medication dose can be adjusted by the study Investigator according to the laboratory results.
EprexDrug
Also called Epoetin alpha
Participants assigned to this arm will receive two subcutaneous administrations per week of 50 UI/kg of Epoetin alpha (Eprex), totaling 100 UI/kg/week. After the first four weeks of treatment, once a month throughout the study the medication dose can be adjusted by the study Investigator according to the laboratory results.

Study groups in NCT01695759
Study group	Role	What they receive
Epoetin alpha	Experimental	Participants assigned to this arm will receive two subcutaneous administrations per week of 50 UI/kg of Epoetin alpha (Eritromax), totaling 100 UI/kg/week. After the first four weeks of treatment, once a month throughout the study the medication dose can be adjusted by the study Investigator according to the laboratory results. Receives: Drug: Epoetin alpha
Eprex	Active comparator	Participants assigned to this arm will receive two subcutaneous administrations per week of 50 UI/kg of Epoetin alpha (Eprex), totaling 100 UI/kg/week. After the first four weeks of treatment, once a month throughout the study the medication dose can be adjusted by the study Investigator according to the laboratory results. Receives: Drug: Eprex

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of hemoglobin levels at correction phase (baseline vs end of treatment)
In the correction phase, change in serum Hb levels (baseline vs. end of initial treatment (EOIT) = levels of Hb presented before the V0 treatment compared to the Hb levels presented at the end of the correction phase) will be evaluated for a maximum period of 6 months after starting treatment. This one parameter will be demonstrated through: Percentage of participants achieving Hb levels within the target (≥ 10.5 to ≤ 12 g / dL).
Measured: until 6 months

Secondary outcomes (4)

Maintenance of hemoglobin levels
Will be evaluated by porcentage of participants whose Hb levels remained within the therapeutic range (≥10,5 a ≤ 12 g/dL).
Measured: until the end of 12 months
Adjustment of EPO dose required during correction and/or maintenance phase
Will be evaluated by mean dose of EPO used between groups and number of participants that needed of dose adjustment over correction and/or maintenance phase.
Measured: until the end of 12 months
Transfusion needs
Will be evaluated by porcentage of participants that needed of blood transfusion throughout the study.
Measured: until the end of 12 months
Report of Adverse Events
Will be evaluated by report of adverse events throughout the study. The Adverse events will be classified about the type, frequency, intensity, seriousness, severity and relation to the investigational product.
Measured: until the end of 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Jan 2018

First posted28 Sep 2012 (estimated)
Study startDec 2013
Primary completionDec 2014
Study completionJan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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
Masking: Single blind
Who is masked: Investigator
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01695759
Sponsor's protocol ID: EPOBLA1011
Other IDs: Emenda 04 - 11/May/2015
Status last verified: Aug 2018
First submitted: 26 Sep 2012
Last updated: 20 Aug 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Clinical Efficacy and Immunogenicity of Drug Eritromax® at Blau Farmacêutica S.A. Compared to Eprex®, Produced by Janssen-Cilag Laboratory in Participants With Secondary Anemia to Chronic Kidney Disease.
ClinicalTrials.gov ID: NCT01695759
Acronym / sponsor ID: EPOBLA1011
Conditions: Chronic Kidney Disease, Anemia
Keywords: Anemia Secondary, Chronic Kidney Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 92 participants (actual)
Lead sponsor: Azidus BrasilIndustry (pharma, biotech, devices)
Collaborators: Blau Farmaceutica S.A.
Study start: Dec 2013 (actual)
Primary completion: Dec 2014 (actual)
Study completion: Jan 2018 (actual)
First posted: 28 Sep 2012 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Epoetin alpha	Experimental	Drug: Epoetin alphaParticipants assigned to this arm will receive two subcutaneous administrations per week of 50 UI/kg of Epoetin alpha (Eritromax), totaling 100 UI/kg/week. After the first four weeks of treatment, once a month throughout the study the medication dose can be adjusted by the study Investigator according to the laboratory results.
Eprex	Active comparator	Drug: EprexParticipants assigned to this arm will receive two subcutaneous administrations per week of 50 UI/kg of Epoetin alpha (Eprex), totaling 100 UI/kg/week. After the first four weeks of treatment, once a month throughout the study the medication dose can be adjusted by the study Investigator according to the laboratory results.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Voluntary participation and agree to all the purposes of the study by signing and dating ICF;
Male or female participantes, regardless of race or social class;
Participants aged ≥18 and ≤70 years;
Bearer dialysis-dependent CKD (hemodialysis and peritoneal dialysis *);
Clinical diagnosis of anemia, characterized as hemoglobin levels <10g/dL before the start of the study;

Key exclusion criteria (8 listed)

Participation in clinical trials in the 12 months preceding the survey;
Patients with uncontrolled hypertension, with mean above 180/100mmHg and whose requiring hospitalization in the last 6 months;
Presence of other causes of anemia than CKD, such as bleeding, hemolysis, pernicious anemia and hemoglobinopathies;
Patients who present changes or clinical abnormalities, qualified as interfering changes, such as severe hyperparathyroidism (iPTH> 1000 pg / mL), severe congestive heart failure (NYHA Class IV), acute myocardial infarction within the last 3 months, or active neoplasia in follow-up, severe liver disease, active infection (leukocyte changes), history of aluminum toxicity or scheduled surgery, pregnancy or lactation;
Patients who have a known hypersensitivity to any component of the formulation and to products derived from mammalian cells;

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
Epoetin alphaParticipants assigned to this arm will receive two subcutaneous administrations per week of 50 UI/kg of Epoetin alpha (Eritromax), totaling 100 UI/kg/week. After the first four weeks of treatment, once a month throughout the study the medication dose can be adjusted by the study Investigator according to the laboratory results.	Drug	Epoetin alpha
EprexAlso: Epoetin alphaParticipants assigned to this arm will receive two subcutaneous administrations per week of 50 UI/kg of Epoetin alpha (Eprex), totaling 100 UI/kg/week. After the first four weeks of treatment, once a month throughout the study the medication dose can be adjusted by the study Investigator according to the laboratory results.	Drug	Eprex

Primary outcome

Change of hemoglobin levels at correction phase (baseline vs end of treatment)
Time frame: until 6 months
In the correction phase, change in serum Hb levels (baseline vs. end of initial treatment (EOIT) = levels of Hb presented before the V0 treatment compared to the Hb levels presented at the end of the correction phase) will be evaluated for a maximum period of 6 months after starting treatment. This one parameter will be demonstrated through: Percentage of participants achieving Hb levels within the target (≥ 10.5 to ≤ 12 g / dL).

4 secondary outcomes

Maintenance of hemoglobin levels
Time frame: until the end of 12 months
Adjustment of EPO dose required during correction and/or maintenance phase
Time frame: until the end of 12 months
Transfusion needs
Time frame: until the end of 12 months
Report of Adverse Events
Time frame: until the end of 12 months

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
Individual participant dataSharing planned: Undecided

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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. This study is not recruiting at the moment.

Regiane Braga, Analyst study chair

Blau Farmaceutica S.A.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epoetin alpha and Eprex in people with Chronic Kidney Disease and Anemia, run by Azidus Brasil at 10 sites in Brazil.

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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Brazil. 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?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of hemoglobin levels at correction phase (baseline vs end of treatment) (time frame: until 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01695759.

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 20 Aug 2018.