None listed
Conditions
Interventions
CERA Type of group
The initial subcutaneous dose of C.E.R.A. it should be based on the patients weight. The recommended dose is 1.2 pg / kg every 4 weeks, administered by injection. WAX. it will be administered every 4 weeks, that is, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, but not in weeks 48 and 52, after all the determinations have been made specific to the visit.
Sponsors
PRODUCTOS ROCHE Q.F.S.A.,
Eligibility
Age
18 Years to 95 Years
Inclusion criteria
Inclusion criteria: • Written informed consent • 18 years of age or older • Chronic renal anemia • Hemoglobin concentration> 8.5 g / dL and 100 ng / mL OR TSAT> 20% OR hypochromic red blood cells 20 ml / min
Exclusion criteria
Exclusion criteria: • Transfusion of red blood cells during the two months before enrollment • Rapid progression of CKD, that is, a reduction in eGFR of more than 10 mL within the last 3 months • Poorly controlled hypertension, that is, seated blood pressure exceeding 170/100, despite medication • Significant chronic or acute bleeding such as obvious gastrointestinal bleeding • Active malignant disease (except non-melanoma skin cancer) • Hemolysis: haptoglobin 105 fL. • Vitamin B12 deficiency, not corrected in the past 2 months judged by local laboratory values, for example, erythrocyte MOV> 105 fL. • Platelet count> 500 x 10 9 / L or 600 • Pregnancy or lactation period • Women with pregnancy potential without effective contraception • Participation in a clinical trial or receipt of a research or treatment compound during the previous 3 months • Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol, or any other constituent of the study medication. • Planned elective surgery (date) during the study period, except for: a Cataract surgery b Vascular access surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of Hb values during the study. Measure:Average change in Hb concentration from the beginning (week 0) and the EPS Timepoints:Key results will be determined in the first 8 weeks after the 24 weeks of the correction period | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation and measurement of Hb values during the study. Measure:Time for response achievement Timepoints:Key results will be determined in the first 8 weeks after the 24 weeks of the correction period ; Outcome name:Measurement of Hb values during the study. Measure:Percentage of patients whose Hb concentrations are within the range of 10.0-12.0 g / dL throughout the EAF. Timepoints:Key results will be determined in the first 8 weeks after the 24 weeks of the correction period ; Outcome name:Measurement of Hb values during the study. Measure:Percentage of patients whose average Hb concentration is within the range of 10.0-12.0 g / dL throughout the PED. Timepoints:Key results will be determined in the first 8 weeks after the 24 weeks of the correction period ; Outcome name:Measurement of Hb values during the study. Measure:Average time used for the Hb range of 10.0-12.0 g / dL during the EAF. Timepoints:Key results will be determined in the first 8 weeks after the 24 weeks of the correction period | — |
Countries
Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, Mexico, Panama, Peru, Uruguay, Venezuela
Contacts
Public ContactAracely Galvez Durand
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed