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

Study Overview
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Brief Summary
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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 disease (CKD), throughout the correction phase by assessing the change in hemoglobin levels.

Detailed Description
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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.

Official Title
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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.

Conditions
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Anemia, Chronic Kidney Disease

Intervention / Treatment
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* Drug: Epoetin alpha
* Drug: Eprex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epoetin alpha<br>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. | Drug: Epoetin alpha<br>* 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.<br>|
| Active Comparator: Eprex<br>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. | Drug: Eprex<br>* 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.<br>* Other names: Epoetin alpha;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | until 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | until the end of 12 months | 
| Transfusion needs | Will be evaluated by porcentage of participants that needed of blood transfusion throughout the study. | 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. | until the end of 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia Secondary, Chronic Kidney Disease