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

NCT01695759 | Terminated Phase 3 DMC

• 2 other identifiers: EPOBLA1011Emenda 04 - 11/May/2015
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 10

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.

Conditions

Chronic Kidney Disease; Anemia

Keywords

Anemia Secondary; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Maintenance of hemoglobin levels

  until the end of 12 months

• Adjustment of EPO dose required during correction and/or maintenance phase

  until the end of 12 months

• Transfusion needs

  until the end of 12 months

• Report of Adverse Events

  until the end of 12 months

Other Outcomes (1)

• Immunological Response

  every six months

Study Arms (2)

Epoetin alpha

EXPERIMENTAL

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

Eprex

ACTIVE COMPARATOR

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

Interventions

Epoetin alpha 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.

Epoetin alpha

Eprex 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.

Also known as: Epoetin alpha

Eprex

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azidus Brasil: lead
• Blau Farmaceutica S.A.: collaborator

Study Sites (10)

Clínica Senhor do Bomfim Ltda

Feira de Santana, Estado de Bahia, 44001-584, Brazil

Location

Instituto Scribner de Ensino, Pesquisa, Ciência e Tecnologia

Curitiba, Paraná, Brazil

Location

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

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

Location

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Location

Fundação Pró-Rim

Joinville, Santa Catarina, Brazil

Location

Hospital de Ensino Padre Anchieta

São Bernardo do Campo, São Paulo, Brazil

Location

CMIN - Clínica De Medicina Interna E Nefrologia

São Paulo, 05001-000, Brazil

Location

Fundação Oswaldo Cruz (Hospital do Rim e Hipertensão)

São Paulo, Brazil

Location

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

São Paulo, Brazil

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Regiane Braga, Analyst

  Blau Farmaceutica S.A.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: September 28, 2012
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

BR (10)