Chronic Renal Insufficiency.
Conditions
Interventions
EPOCIM:25-200 IU/kg(subcutaneously)3 times per week for 12 months.
Sponsors
Center of Molecular Immunology(CIM)
No proceed.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients with inform consent signed. 2.Patients with stable dialysis treatment at least of 3 months prior. 3.Patients who are receiving ior EPOCIM for the treatment of anemia associated with CRF. 4.Age less than 18 years. 5.To be included in the study patients of both sexes.
Exclusion criteria
Exclusion criteria: 1.Patients with known hypersensitivity to products derived from cells above or hypersensitivity to human albumin. 2.Patients pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin(g/dl), Hematocrit(%), Assessment of response (Optimal, Good, Fair, Poor), Response Type (Maintain, Increase, Decrease). Measurement time: 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical parameters:The values recorded by the units set for each,measurement time:12 months. Occurrence of any adverse event in the subject:yes/no,measurement time:12 months. Duration of the adverse event:Dates of commencement and completion of the adverse event,measurement time:12 months. Intensity of adverse event:Slight,Moderate,Severe,Very severe,measurement time:12 months. Causal relationship:Very likely, likely, possible, remote,measurement time:12 months. Attitude to treatment:No change, modification of dosage, temporary interruption final,measurement time:12 months. Result of the treatment applied to counter adverse event:Recovered,Improved,sequelae persists,measurement time:12 months. Indicators of Quality of Life,will assess the improvement of the parameters of quality of life through Fact-An Inquiry,measurement time:12 months. | — |
Countries
Cuba
Contacts
Public ContactMD.Patricia Piedra
CIMAB S.A
Outcome results
None listed