Chronic Kidney Disease -
Conditions
Interventions
Ior®EPOCIM group (Experimental): ior®EPOCIM (in bulbs 2000 UI, 4000 UI o 10 000 UI) in regular doses of 30 to 100 UI/kg/weekly, intravenously (IV) or subcutaneously (SC) for a year.
Erythropoietin
Injections, Subcutaneous
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Diagnosis of Chronic Kidney Disease in dialysis program (hemodialysis or peritoneal dialysis). 2. Adult patients (> 18 years). 3. Initiation of treatment with new production erythropoietin or change from another erythropoietin to this within the last 30 days. 4. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Cancer patients. 2. Patients with uncontrolled hypertension. 3. Patients with hypersensitivity to human albumin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious adverse reactions (Exposure dose and dose range, specifically for adverse events of interest, such as: severe hypertension, acute myocardial infarction, stroke, thromboembolism, and death). Measurement time: up to one year of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-Hemoglobin level at the time of severe RAM-Adverse drug reaction (Expressed in g/dl). Measurement time: at the time of the adverse drug reaction during the year of treatment. 2-Hematocrit level at the time of severe RAM (Expressed in %). Measurement time: at the time of the adverse drug reaction during the year of treatment. 3-Transfusions (number of transfusions received). Measurement time: Monthly, during the year of treatment. | — |
Countries
Cuba
Contacts
Public ContactGiselle Saurez Martinez
Center of Molecular Immunology (CIM)
Outcome results
None listed