Evaluation Of Clinical Efficacy And Immunogenicity Of Eritromax® Produced By Lab Blau Pharmaceutical S / A. Compared To The Product Eprex®, Produced By The Laboratory Janssen-Cilag, In Patients With Anemia Secondary To Chronic Kidney Disease

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Sponsor:
Information provided by (Responsible Party):
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01695759
First received: September 26, 2012
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

To evaluate the clinical efficacy and immunogenicity of the drug test Eritromax ® - (rHuEPO Blau) compared to drug Eprex ® (Janssen-Cilag rHuEPO) in the treatment of patients who have anemia secondary to chronic kidney disease (CKD), during the correction through assessing the change in hemoglobin levels.


Condition Intervention Phase
Chronic Kidney Disease
Anemia
Drug: Epoetin Alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Change of serum Hb (baseline vs end of treatment (EOIT) [ Time Frame: until 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maintenance of Hb levels [ Time Frame: until the end of 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 210
Study Start Date: March 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epoetin alfa
Epoetin alfa Test - Blau
Drug: Epoetin Alfa
The drug will be administered subcutaneously and the initial dose is 50 IU / kg. This dose will be administrated twice/week, totaling 100 U / kg / week.
Active Comparator: Eprex
Epoetin alfa Comparator - JANSSEN-CILAG
Drug: Epoetin Alfa
The drug will be administered subcutaneously and the initial dose is 50 IU / kg. This dose will be administrated twice/week, totaling 100 U / kg / week.

Detailed Description:

Data will be assessed secondary efficacy of the drug against the test drug comparison by evaluating:

  • Maintenance of hemoglobin levels (baseline vs. end of treatment) during maintenance phase;
  • Dose of EPO necessary during the repair and maintenance;
  • Need for transfusion;
  • Safety study drugs by type, frequency and intensity of adverse events during the 12 months of follow up.

objectives exploratory

  • evaluate the immunogenicity of drugs through the quantification of anti-erythropoietin every six months.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

a. Confirm voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways; b. Male or female, regardless of race or social class; c. Age between 18 and 60 years; d. Bearer dialysis-dependent CKD (hemodialysis and peritoneal dialysis *); and. Present clinical diagnosis of anemia, characterized in hemoglobin levels <10g/dL before the start of the study; f. Adequate dialysis: Kt / V ≥ 1.2 for hemodialysis patients and ≥ 1.8 for patients on peritoneal dialysis (based on the calculation of Daugirdas II); g. Display 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 above average 180/100mmHg and requiring hospitalization in the last 6 months;
  3. Presence of other causes of anemia than CRD, 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; and. Patients who have a known hypersensitivity to any component of the formulation and to products derived from mammalian cells;

f. Prior therapies with erythropoietin for less than 3 months; g. Realization transfusion for less than 3 months; h. Any situation at the discretion of the Principal Investigator interfere with study data.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695759

Contacts
Contact: Alexandre Frederico, physician (19) 38716399 alexandre@lalclinica.com.br

Locations
Brazil
Instituto Scribner de Ensino, Pesquisa, Ciência e Tecnologia Not yet recruiting
Curitiba, Parana, Brazil
Contact: Miguel Carlos Riella    (41) 3027-5442    mcriella@pro-renal.org.br   
Principal Investigator: Miguel Carlos Riella         
União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Domingos Otávio Lorenzoni D'Avila    (51) 3320-3479    pesquisanefropucrs@hotmail.com   
Principal Investigator: Domingos Otávio Lorenzoni D'Avila         
Irmandade da Santa Casa de Misericórdia de Porto Alegre Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: João Carlos Goldani    (51) 3214-8640    ronivantxsantacasa@yahoo.com.br   
Principal Investigator: João Carlos Goldani         
Hospital de Ensino Padre Anchieta Not yet recruiting
São Bernardo do Campo, São Paulo, Brazil
Contact: João Batista Douverny, physician    (11) 4930-4243    cemec.abc@terra.com.br   
Principal Investigator: João Batista Douverny         
Fundação Oswaldo Cruz (Hospital do Rim e Hipertensão) Not yet recruiting
São Paulo, Brazil
Contact: Maria Eugênia Canziani    (11) 5904-8499    dialisefor@uol.com.br   
Principal Investigator: Maria Eugênia Canziani         
Real e Benemérita Associação Portuguesa de Beneficência São Paulo (Hospital Beneficência Portuguesa) Not yet recruiting
São Paulo, Brazil
Contact: Irene de Lourdes Noronha    (11) 2359-2703    irenenor@usp.br   
Principal Investigator: Irene de Lourdes Noronha         
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier: NCT01695759     History of Changes
Other Study ID Numbers: EPOBLA1011, Emenda 01 13/08/2012
Study First Received: September 26, 2012
Last Updated: September 27, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Anemia Secondary
Chronic Kidney Disease

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014