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

NCT ID: NCT01695759

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2018-01-31

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Epoetin alpha

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.

Group Type: EXPERIMENTAL

Epoetin alpha

Intervention Type: DRUG

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.

Eprex

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.

Group Type: ACTIVE_COMPARATOR

Eprex

Intervention Type: DRUG

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.

Interventions

Epoetin alpha

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.

Intervention Type: DRUG

Eprex

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.

Intervention Type: DRUG

Other Intervention Names

Epoetin alpha

Eligibility Criteria

Inclusion Criteria

1. Voluntary participation and agree to all the purposes of the study by signing and dating ICF;

2. Male or female participantes, regardless of race or social class;

3. Participants aged ≥18 and ≤70 years;

4. Bearer dialysis-dependent CKD (hemodialysis and peritoneal dialysis *);

5. Clinical diagnosis of anemia, characterized as hemoglobin levels <10g/dL before the start of the study;

6. Adequate dialysis: Kt / V ≥ 1.2 for hemodialysis patients (based on the calculation of Daugirdas II) and ≥ 1.7 for patients on peritoneal dialysis;

7. Adequate iron stores (TSAT> 20% and serum ferritin> 100ng/ml) prior to initiation of treatment with erythropoietin.

Exclusion Criteria

1. Participation in clinical trials in the 12 months preceding the survey;

2. Patients with uncontrolled hypertension, with mean above 180/100mmHg and whose requiring hospitalization in the last 6 months;

3. Presence of other causes of anemia than CKD, such as bleeding, hemolysis, pernicious anemia and hemoglobinopathies;

4. 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;

5. Patients who have a known hypersensitivity to any component of the formulation and to products derived from mammalian cells;

6. Prior therapies with erythropoietin for less than 3 months;

7. Realization transfusion for less than 3 months;

8. Any situation at the discretion of the Principal Investigator interfere with study data.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Blau Farmaceutica S.A.

INDUSTRY

Sponsor Role: collaborator

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Regiane Braga, Analyst

Role: STUDY_CHAIR

Blau Farmaceutica S.A.

Locations

Clínica Senhor do Bomfim Ltda

Feira de Santana, Estado de Bahia, Brazil

Instituto Scribner de Ensino, Pesquisa, Ciência e Tecnologia

Curitiba, Paraná, Brazil

Fundação Universitária de Caxias do Sul - Instituto de Pesquisa Clínica para Estudos Multicêntricos

Caxias do Sul, Rio Grande do Sul, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Pró-Rim

Joinville, Santa Catarina, Brazil

Hospital de Ensino Padre Anchieta

São Bernardo do Campo, São Paulo, Brazil

CMIN - Clínica De Medicina Interna E Nefrologia

São Paulo, , Brazil

Fundação Oswaldo Cruz (Hospital do Rim e Hipertensão)

São Paulo, , Brazil

Real e Benemérita Associação Portuguesa de Beneficência São Paulo (Hospital Beneficência Portuguesa)

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

Emenda 04 - 11/May/2015

Identifier Type: OTHER

Identifier Source: secondary_id

EPOBLA1011

Identifier Type: -

Identifier Source: org_study_id