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

Sponsor

Azidus Brasil (Industry)

Overall Status

Terminated

CT.gov ID

NCT01695759

Collaborator

Blau Farmaceutica S.A. (Industry)

Enrollment

Locations

Arms

Actual Duration (Months)

9.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Anemia	Drug: Epoetin alpha Drug: Eprex	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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.	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. Other Names: Epoetin alpha

Arm

Intervention/Treatment

Experimental: 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.

Drug: Epoetin alpha

Active Comparator: 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.

Drug: Eprex

Other Names:

Epoetin alpha

Outcome Measures

Primary Outcome Measures

Change of hemoglobin levels at correction phase (baseline vs end of treatment) [until 6 months]
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).

Secondary Outcome Measures

Maintenance of hemoglobin levels [until the end of 12 months]
Will be evaluated by porcentage of participants whose Hb levels remained within the therapeutic range (≥10,5 a ≤ 12 g/dL).
Adjustment of EPO dose required during correction and/or maintenance phase [until the end of 12 months]
Will be evaluated by mean dose of EPO used between groups and number of participants that needed of dose adjustment over correction and/or maintenance phase.
Transfusion needs [until the end of 12 months]
Will be evaluated by porcentage of participants that needed of blood transfusion throughout the study.
Report of Adverse Events [until the end of 12 months]
Will be evaluated by report of adverse events throughout the study. The Adverse events will be classified about the type, frequency, intensity, seriousness, severity and relation to the investigational product.

Other Outcome Measures

Immunological Response [every six months]
The immunological response induced by epoetin alpha will be evaluated by quantification of anti-erithropoetin antibodies, every six months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clínica Senhor do Bomfim Ltda	Feira de Santana	Bahia	Brazil	44001-584
2	Instituto Scribner de Ensino, Pesquisa, Ciência e Tecnologia	Curitiba	Parana	Brazil
3	Fundação Universitária de Caxias do Sul - Instituto de Pesquisa Clínica para Estudos Multicêntricos	Caxias do Sul	Rio Grande Do Sul	Brazil	95070-561
4	Irmandade da Santa Casa de Misericórdia de Porto Alegre	Porto Alegre	Rio Grande Do Sul	Brazil
5	União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS	Porto Alegre	Rio Grande Do Sul	Brazil
6	Fundação Pró-Rim	Joinville	Santa Catarina	Brazil
7	Hospital de Ensino Padre Anchieta	São Bernardo do Campo	São Paulo	Brazil
8	CMIN - Clínica De Medicina Interna E Nefrologia	São Paulo		Brazil	05001-000
9	Fundação Oswaldo Cruz (Hospital do Rim e Hipertensão)	São Paulo		Brazil
10	Real e Benemérita Associação Portuguesa de Beneficência São Paulo (Hospital Beneficência Portuguesa)	São Paulo		Brazil