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

Last updated: August 17, 2018
Sponsor: Azidus Brasil
Overall Status: Terminated

Phase

3

Condition

Kidney Disease

Nephropathy

Kidney Failure

Treatment

N/A

Clinical Study ID

NCT01695759
EPOBLA1011
Emenda 04 - 11/May/2015
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Voluntary participation and agree to all the purposes of the study by signing anddating 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 thestart of the study;

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

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

Exclusion

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 whoserequiring hospitalization in the last 6 months;

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

  4. Patients who present changes or clinical abnormalities, qualified as interferingchanges, such as severe hyperparathyroidism (iPTH> 1000 pg / mL), severe congestiveheart failure (NYHA Class IV), acute myocardial infarction within the last 3 months,or active neoplasia in follow-up, severe liver disease, active infection (leukocytechanges), history of aluminum toxicity or scheduled surgery, pregnancy or lactation;

  5. Patients who have a known hypersensitivity to any component of the formulation and toproducts 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 studydata.

Study Design

Total Participants: 92
Study Start date:
December 01, 2013
Estimated Completion Date:
January 31, 2018

Study 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.

Connect with a study center

  • Clínica Senhor do Bomfim Ltda

    Feira de Santana, Bahia 44001-584
    Brazil

    Site Not Available

  • Instituto Scribner de Ensino, Pesquisa, Ciência e Tecnologia

    Curitiba, Parana
    Brazil

    Site Not Available

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

    Caxias do Sul, Rio Grande Do Sul 95070-561
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande Do Sul
    Brazil

    Site Not Available

  • União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande Do Sul
    Brazil

    Site Not Available

  • Fundação Pró-Rim

    Joinville, Santa Catarina
    Brazil

    Site Not Available

  • Hospital de Ensino Padre Anchieta

    São Bernardo do Campo, São Paulo
    Brazil

    Site Not Available

  • CMIN - Clínica De Medicina Interna E Nefrologia

    São Paulo, 05001-000
    Brazil

    Site Not Available

  • Fundação Oswaldo Cruz (Hospital do Rim e Hipertensão)

    São Paulo,
    Brazil

    Site Not Available

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

    São Paulo,
    Brazil

    Site Not Available

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