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

• Status: Terminated
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azidus Brasil
• Collaborator: Blau Farmaceutica S.A.
• Treatments: Epoetin Alfa

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.