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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Azidus Brasil
Sponsor:
Information provided by (Responsible Party):
Azidus Brasil
ClinicalTrials.gov Identifier:
NCT01695759
First received: September 26, 2012
Last updated: April 6, 2016
Last verified: April 2016
  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 alpha
Drug: Eprex
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
Official Title: Evaluation of Clinical Efficacy and Immunogenicity of Drug Eritromax® at Blau Farmacêutica S.A. Laboratory in Relation to Drug Eprex®, Produced by Janssen-Cilag Laboratory in Participants With Secondary Anemia to Chronic Kidney Disease.

Resource links provided by NLM:


Further study details as provided by Azidus Brasil:

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: December 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epoetin alpha
The Epoetin alpha Test will be administered subcutaneously and the initial dose of the same is 50 IU / kg. two weekly administrations will be held, totaling 100 U / kg / week. After the first 4 weeks of treatment, the dose of the drug may be modified by the Principal Investigator during the study, according to the results of laboratory tests.
Drug: Epoetin alpha
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
The Epoetin alphaComparator will be administered subcutaneously and the initial dose of the same is 50 IU / kg. two weekly administrations will be held, totaling 100 U / kg / week. After the first 4 weeks of treatment, the dose of the drug may be modified by the Principal Investigator during the study, according to the results of laboratory tests.
Drug: Eprex
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.
Other Name: Epoetin alpha

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   (Adult)
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 55(19) 38296160 ext 240 alexandre@lalclinica.com.br
Contact: Regiane Braga, research 55(11) 4615-9400 ext 9517 mguidoni@blau.com.br

Locations
Brazil
Clínica Senhor do Bomfim Ltda Recruiting
Feira de Santana, Bahia, Brazil, 44001-584
Contact: Edson Luiz Paschoalin, physician    55 (75) 3211-1919      
Principal Investigator: Edson Luiz Paschoalin, physician         
Instituto Scribner de Ensino, Pesquisa, Ciência e Tecnologia Recruiting
Curitiba, Parana, Brazil
Contact: Miguel Carlos Riella, physician    55(41)3027-5442    mcriella@pro-renal.org.br   
Principal Investigator: Miguel Carlos Riella, physician         
Fundação Universitária de Caxias do Sul - Instituto de Pesquisa Clínica para Estudos Multicêntricos Recruiting
Caxias do Sul, Rio Grande do Sul, Brazil, 95070-561
Contact: Marcelo Garrafiel Bombel, physician    55 (54) 32187200    mgbombel@hotmail.com   
Principal Investigator: Marcelo Garrafiel Bombel, physician         
União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Domingos Otávio Lorenzoni D'Avila, physician    (51) 3320-3479    pesquisanefropucrs@hotmail.com   
Principal Investigator: Domingos Otávio Lorenzoni D'Avila, physician         
Irmandade da Santa Casa de Misericórdia de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: João Carlos Goldani, physician    (51) 3214-8640    ronivantxsantacasa@yahoo.com.br   
Principal Investigator: João Carlos Goldani, physician         
Fundação Pró-Rim Recruiting
Joinville, Santa Catarina, Brazil
Contact: Luciane Mônica Deboni, physician    55(47) 3434-2090    imdeboni@terra.com.br   
Principal Investigator: Luciane Mônica Deboni, physician         
Hospital de Ensino Padre Anchieta Recruiting
São Bernardo do Campo, São Paulo, Brazil
Contact: João Batista Douverny, physician    55 (11) 4930-4243    cemec.abc@terra.com.br   
Principal Investigator: João Batista Douverny, physician         
Real e Benemérita Associação Portuguesa de Beneficência São Paulo (Hospital Beneficência Portuguesa) Recruiting
São Paulo, Brazil
Contact: Irene de Lourdes Noronha, physician    (11) 2359-2703    irenenor@usp.br   
Principal Investigator: Irene de Lourdes Noronha, physician         
CMIN - Clínica De Medicina Interna E Nefrologia Not yet recruiting
São Paulo, Brazil, 05001-000
Contact: Renato Watanabe, physician    55(11) 3865-2634      
Principal Investigator: Renato Watanabe, physician         
Fundação Oswaldo Cruz (Hospital do Rim e Hipertensão) Recruiting
São Paulo, Brazil
Contact: Maria Eugênia Canziani, physician    55(11)5904-8499    dialisefor@uol.com.br   
Principal Investigator: Maria Eugênia Canziani, physician         
Sponsors and Collaborators
Azidus Brasil
Investigators
Study Director: Márcia Guidoni, manager Blau Farmacêutica S.A.
  More Information

Responsible Party: Azidus Brasil
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: April 6, 2016
Health Authority: Brazil: National Health Surveillance Agency
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Azidus Brasil:
Anemia Secondary
Chronic Kidney Disease

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on July 25, 2016