Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT01695759
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01695759
Study Brief:
Protocol Section:
NCT01695759