Chronic Renal Failure.
Conditions
Interventions
One group will receive EPO W/A and the other will receive EPOCIM:(20-200UI/kg body weight),corresponding 1:1(iorEPOCIM:EPO W/A). Both products will be administered by the usual route(subcutaneous or i
Sponsors
Center of Molecular Inmunology(CIM)
No proceed
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients who have given their consent to participate in the study in writing. 2.Patients aged between 18 and 70 years. 3.Treatment with stable dialysis patients for a minimum period of 6 months. 4.Patients who have received ior EPOCIM for the treatment of anemia associated with CRF and maintain levels equal to or greater than 30% of hematocrit and hemoglobin equal to or greater than 10g/dL with a stable dose of EPOCIM for 3 months. 5.Includes patients of both sexes in the study.
Exclusion criteria
Exclusion criteria: 1.Pregnant patients,nursing or women of childbearing age who are not using contraception. 2.Patients with uncontrolled arterial hypertension. 3.Patients receiving treatment with immunosuppressive agents. 4.Patients with a history of epilepsy. 5.Patients with sepsis or active infection. 6.Patients with active acute or chronic inflammatory. 7.Patients who have been transfused in the month prior to the assessment for inclusion. 8.Patients with hematologic diseases. 9.Patients with Severe Hyperparathyroidism. 10.Patients with a diagnosis of malignancy or therapy Anticancer. 11.Renal transplant patients scheduled to coincide with period of study. 12.Patients with known hypersensitivity to products derived from mammalian cells. 13.Psychiatric patients with decompensated. 14.Patients with alcoholism or drug addiction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin/hematocrit (g/dl),measurement time 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood chemistry: creatinine, glucose, TGP, TGO, albumin, calcium, phosphate, ferritin, transferrin, serum iron, measurement time 12 weeks. Hematology: Counting of Reticulocytes, leukocytes, erythrocytes, measurement time 12 weeks. Safety assessment, number of transfusions, dose and frequency of administration of erythropoietin, Measuring time: 12 weeks. Occurrence of any adverse events (AE) in the subject, yes/no, Measuring time: 12 weeks. Duration of Adverse Event (AE), in minutes or days, measuring time: 12 weeks. Intensity of adverse events (AE),Slight, Moderate, Severe, Very severe, measuring time:12 weeks. Causal relationship, very likely, likely, possible, remote, Measuring time: 12 weeks. Attitude to treatment, no change, modification of dose, Interrupted temporary interruption ultimately, Measuring time: 12 weeks. Result of the treatment to counteract the adverse events (AE), recovered, improved, persisted, sequelae, measurement time: 12 weeks. Antibodies antiEPO, the values recorded according to the determinations made for each patient, measurement time :12 weeks. | — |
Countries
Cuba
Contacts
Public ContactMD.Patricia Piedra
CIMAB S.A
Outcome results
None listed