Effectiveness and safety of ior®EPOCIM in Chronic Kidney Disease patients in pre-dialysis.
Phase 4
Recruiting
- Conditions
- Anemia secondary to Chronic Kidney Disease
- Registration Number
- RPCEC00000123
- Lead Sponsor
- CIMAB-Center of Molecular Immunology (CIM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 425
Inclusion Criteria
1. Patients that fulfill the diagnostic criteria. 2. Patients that give a written consent 3. Patient with age over or equal to 18 years. 4. Patients of both sexes.
Exclusion Criteria
1. Patients with known hypersensitivity to products derived from superior cells or hypersensitivity to human albumin. 2. Pregnant or breastfeeding patients. 3. Patients with other non-renal anemia. 4. Patients with Class III-IV Heart Failure, according to the New York Heart Association Classification. 5. Patients with oncologic disease diagnose.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hematologic response (Values of Hemoglobin in g/l and Hematocrit in %). Measuring time: monthly until the end of the treatment (1 year).
- Secondary Outcome Measures
Name Time Method