Phase
Condition
Kidney Disease
Nephropathy
Kidney Failure
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntary participation and agree to all the purposes of the study by signing anddating 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 thestart of the study;
Adequate dialysis: Kt / V ≥ 1.2 for hemodialysis patients (based on the calculation ofDaugirdas II) and ≥ 1.7 for patients on peritoneal dialysis;
Adequate iron stores (TSAT> 20% and serum ferritin> 100ng/ml) prior to initiation oftreatment with erythropoietin.
Exclusion
Exclusion Criteria:
Participation in clinical trials in the 12 months preceding the survey;
Patients with uncontrolled hypertension, with mean above 180/100mmHg and whoserequiring hospitalization in the last 6 months;
Presence of other causes of anemia than CKD, such as bleeding, hemolysis, perniciousanemia and hemoglobinopathies;
Patients who present changes or clinical abnormalities, qualified as interferingchanges, such as severe hyperparathyroidism (iPTH> 1000 pg / mL), severe congestiveheart failure (NYHA Class IV), acute myocardial infarction within the last 3 months,or active neoplasia in follow-up, severe liver disease, active infection (leukocytechanges), history of aluminum toxicity or scheduled surgery, pregnancy or lactation;
Patients who have a known hypersensitivity to any component of the formulation and toproducts 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 studydata.
Study Design
Study Description
Connect with a study center
Clínica Senhor do Bomfim Ltda
Feira de Santana, Bahia 44001-584
BrazilSite Not Available
Instituto Scribner de Ensino, Pesquisa, Ciência e Tecnologia
Curitiba, Parana
BrazilSite Not Available
Fundação Universitária de Caxias do Sul - Instituto de Pesquisa Clínica para Estudos Multicêntricos
Caxias do Sul, Rio Grande Do Sul 95070-561
BrazilSite Not Available
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande Do Sul
BrazilSite Not Available
União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande Do Sul
BrazilSite Not Available
Fundação Pró-Rim
Joinville, Santa Catarina
BrazilSite Not Available
Hospital de Ensino Padre Anchieta
São Bernardo do Campo, São Paulo
BrazilSite Not Available
CMIN - Clínica De Medicina Interna E Nefrologia
São Paulo, 05001-000
BrazilSite Not Available
Fundação Oswaldo Cruz (Hospital do Rim e Hipertensão)
São Paulo,
BrazilSite Not Available
Real e Benemérita Associação Portuguesa de Beneficência São Paulo (Hospital Beneficência Portuguesa)
São Paulo,
BrazilSite Not Available
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