Clinical trial NCT01695759: Clinical Efficacy of Two Erythropoietin Drug in Participants With Secondary Anemia to Chronic Kidney Disease.
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Anemia
Keywords: Anemia Secondary
Chronic Kidney Disease
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
Collaborators: name: Blau Farmaceutica S.A.
First posted: 2012-09-28
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of hemoglobin levels at correction phase (baseline vs end of treatment)
timeFrame: until 6 months
Secondary outcomes:
measure: Maintenance of hemoglobin levels
timeFrame: until the end of 12 months
measure: Adjustment of EPO dose required during correction and/or maintenance phase
timeFrame: until the end of 12 months
measure: Transfusion needs
timeFrame: until the end of 12 months
measure: Report of Adverse Events
timeFrame: until the end of 12 months
Other outcomes:
measure: Immunological Response
timeFrame: every six months
Locations:
city: Feira de Santana
country: Brazil
facility: Clínica Senhor do Bomfim Ltda
state: Bahia
city: Curitiba
country: Brazil
facility: Instituto Scribner de Ensino, Pesquisa, Ciência e Tecnologia
state: Parana
city: Caxias do Sul
country: Brazil
facility: Fundação Universitária de Caxias do Sul - Instituto de Pesquisa Clínica para Estudos Multicêntricos
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Fundação Pró-Rim
state: Santa Catarina
city: São Bernardo do Campo
country: Brazil
facility: Hospital de Ensino Padre Anchieta
state: São Paulo
city: São Paulo
country: Brazil
facility: CMIN - Clínica De Medicina Interna E Nefrologia
city: São Paulo
country: Brazil
facility: Fundação Oswaldo Cruz (Hospital do Rim e Hipertensão)
city: São Paulo
country: Brazil
facility: Real e Benemérita Associação Portuguesa de Beneficência São Paulo (Hospital Beneficência Portuguesa)
Study officials:
affiliation: Blau Farmaceutica S.A.
name: Regiane Braga, Analyst
role: STUDY_CHAIR
References: