Therapeutic Equivalence between ior EPOCIM and EPO without albumin, for patients with Chronic Renal failure on Peritoneal dialysis methods.(Hemodialysis or peritoneal dialysis).
- Conditions
- Chronic Renal Failure.
- Registration Number
- RPCEC00000077
- Lead Sponsor
- Center of Molecular Inmunology(CIM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hemoglobin/hematocrit (g/dl),measurement time 12 weeks.
- Secondary Outcome Measures
Name Time Method