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

Anemia Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01695759
• Other study ID #: EPOBLA1011
• Secondary ID: Emenda 04 - 11/M
• Status: Terminated
• Phase: Phase 3
• Start date: December 2013
• Est. completion date: January 2018

Study information

• Verified date: August 2018
• Source: Azidus Brasil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 92
• Est. completion date: January 2018
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Fundação Universitária de Caxias do Sul - Instituto de Pesquisa Clínica para Estudos Multicêntricos	Caxias do Sul	Rio Grande Do Sul
Brazil	Instituto Scribner de Ensino, Pesquisa, Ciência e Tecnologia	Curitiba	Parana
Brazil	Clínica Senhor do Bomfim Ltda	Feira de Santana	Bahia
Brazil	Fundação Pró-Rim	Joinville	Santa Catarina
Brazil	Irmandade da Santa Casa de Misericórdia de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital de Ensino Padre Anchieta	São Bernardo do Campo	São Paulo
Brazil	CMIN - Clínica De Medicina Interna E Nefrologia	São Paulo
Brazil	Fundação Oswaldo Cruz (Hospital do Rim e Hipertensão)	São Paulo
Brazil	Real e Benemérita Associação Portuguesa de Beneficência São Paulo (Hospital Beneficência Portuguesa)	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Azidus Brasil	Blau Farmacêutica S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immunological Response	The immunological response induced by epoetin alpha will be evaluated by quantification of anti-erithropoetin antibodies, every six months.	every six months
Primary	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	Maintenance of hemoglobin levels	Will be evaluated by porcentage of participants whose Hb levels remained within the therapeutic range (=10,5 a = 12 g/dL).	until the end of 12 months
Secondary	Adjustment of EPO dose required during correction and/or maintenance phase	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.	until the end of 12 months
Secondary	Transfusion needs	Will be evaluated by porcentage of participants that needed of blood transfusion throughout the study.	until the end of 12 months
Secondary	Report of Adverse Events	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.	until the end of 12 months