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

Primary Purpose

Chronic Kidney Disease, Anemia

Status
Terminated
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Epoetin alpha
Eprex
Sponsored by
Azidus Brasil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Anemia Secondary, Chronic Kidney Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clínica Senhor do Bomfim Ltda
  • Instituto Scribner de Ensino, Pesquisa, Ciência e Tecnologia
  • Fundação Universitária de Caxias do Sul - Instituto de Pesquisa Clínica para Estudos Multicêntricos
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS
  • Fundação Pró-Rim
  • Hospital de Ensino Padre Anchieta
  • CMIN - Clínica De Medicina Interna E Nefrologia
  • Fundação Oswaldo Cruz (Hospital do Rim e Hipertensão)
  • Real e Benemérita Associação Portuguesa de Beneficência São Paulo (Hospital Beneficência Portuguesa)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Epoetin alpha

Eprex

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
Transfusion needs
Will be evaluated by porcentage of participants that needed of blood transfusion throughout the study.
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.

Full Information

First Posted
September 26, 2012
Last Updated
August 17, 2018
Sponsor
Azidus Brasil
Collaborators
Blau Farmaceutica S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01695759
Brief Title
Clinical Efficacy of Two Erythropoietin Drug in Participants With Secondary Anemia to Chronic Kidney Disease.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Study Start Date
December 2013 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azidus Brasil
Collaborators
Blau Farmaceutica S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Anemia
Keywords
Anemia Secondary, Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epoetin alpha
Arm Type
Experimental
Arm Description
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.
Arm Title
Eprex
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Epoetin alpha
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Eprex
Other Intervention Name(s)
Epoetin alpha
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of hemoglobin levels at correction phase (baseline vs end of treatment)
Description
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).
Time Frame
until 6 months
Secondary Outcome Measure Information:
Title
Maintenance of hemoglobin levels
Description
Will be evaluated by porcentage of participants whose Hb levels remained within the therapeutic range (≥10,5 a ≤ 12 g/dL).
Time Frame
until the end of 12 months
Title
Adjustment of EPO dose required during correction and/or maintenance phase
Description
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.
Time Frame
until the end of 12 months
Title
Transfusion needs
Description
Will be evaluated by porcentage of participants that needed of blood transfusion throughout the study.
Time Frame
until the end of 12 months
Title
Report of Adverse Events
Description
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.
Time Frame
until the end of 12 months
Other Pre-specified Outcome Measures:
Title
Immunological Response
Description
The immunological response induced by epoetin alpha will be evaluated by quantification of anti-erithropoetin antibodies, every six months.
Time Frame
every six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Regiane Braga, Analyst
Organizational Affiliation
Blau Farmaceutica S.A.
Official's Role
Study Chair
Facility Information:
Facility Name
Clínica Senhor do Bomfim Ltda
City
Feira de Santana
State/Province
Bahia
ZIP/Postal Code
44001-584
Country
Brazil
Facility Name
Instituto Scribner de Ensino, Pesquisa, Ciência e Tecnologia
City
Curitiba
State/Province
Parana
Country
Brazil
Facility Name
Fundação Universitária de Caxias do Sul - Instituto de Pesquisa Clínica para Estudos Multicêntricos
City
Caxias do Sul
State/Province
Rio Grande Do Sul
ZIP/Postal Code
95070-561
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Fundação Pró-Rim
City
Joinville
State/Province
Santa Catarina
Country
Brazil
Facility Name
Hospital de Ensino Padre Anchieta
City
São Bernardo do Campo
State/Province
São Paulo
Country
Brazil
Facility Name
CMIN - Clínica De Medicina Interna E Nefrologia
City
São Paulo
ZIP/Postal Code
05001-000
Country
Brazil
Facility Name
Fundação Oswaldo Cruz (Hospital do Rim e Hipertensão)
City
São Paulo
Country
Brazil
Facility Name
Real e Benemérita Associação Portuguesa de Beneficência São Paulo (Hospital Beneficência Portuguesa)
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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