Transfer factor in Chronic Kidney Disease

INTERVENTION: Transfer Factor Treatment group: 1 U of HEBERTRANS (Transfer Factor), subcutaneously, twice a week, in the first and last hemodialysis session of the week and always post‐hemodialysis, for 8 weeks. The treatment will be continued by administering 1U weekly subcutaneously post‐hemodialysis, for the next 8 weeks, until completing the treatment that will have a total of 16 weeks. Control group: you will receive the usual hemodialysis treatment. CONDITION: Kidney Failure, Chronic Stage 5 Chronic Kidney Disease under an iterated hemodialysis regimen PRIMARY OUTCOME: Cellular immune response: Concentration of leukocyte populations (lymphocyte subpopulations; T lymphocytes: CD3, CD4 (CD3 + / CD4 +), CD8 (CD3 + / CD8 +), CD4 / CD8 ratio; B lymphocytes: (CD19 +); NK / NKT cells: (CD3 ‐CD56 + / CD3 + CD56 +)). Measurement time: at baseline and, at weeks 9 and 17. INCLUSION CRITERIA: 1) Patients who meet the diagnostic criteria. 2) Patients of any sex, with an age greater than or equal to 18 years. 3) Stable patients, with more than 3 months and less than 3 years, on hemodialysis. 4) Patients who express their consent in writing, to participate in the study. SECONDARY OUTCOME: 1) Cellular immune response (Concentration of leukocyte populations (Monocyte / Granulocyte subpopulations [Proinflammatory markers], monocytes: (CD14 + / CD16‐), (CD14 + / CD16 +/‐), (CD16 + / CD16 +); granulocytes: (CD33 + / CD15 + / CD11b)). Measurement time: at baseline and, at weeks 9 and 17. 2) Functionality of the immune system (In leukocyte populations: Expression of leukocyte activation markers in monocytes and lymphocytes: (HLADR and CD38); Regulatory cell fraction analysis: (CD45 +, CD4 +, CD25 +, D127 low); Recent migrant cells of the Thymus: (CD45RA +, CD62L +, CD31 +); Circulating memory populations: (CD4 and CD8 +, CD28, CD57, D45RA, CR7 and CD62L)). Measurement time: at baseline and, at weeks 9 and 17. 3) Antigen‐specific delayed hypersensitivity response (Tuberculin antigen (PPD); Candidine; Tetanus toxoid). Measurement time: at baseline and, at weeks 9 and 17. 4) General immunological response (Hematological response (Lymphocytes, Monocytes, Granulocytes, Platelets; Neutrophil / lymphocyte ratio (NLR), Platelet / lymphocyte ratio, NLR / Platelet ratio). Measurement time: at baseline and, at weeks 9 and 17. 5) Immunological (Humoral immune response). Quantification of Immunoglobulins and Complement (Quantification of Immunoglobulins: IgA, IgM, IgG; Components of the complement system: C3 and C4). Measurement time: at baseline and, at weeks 9 and 17. 6) Soluble markers of the inflammatory response. Quantification of the soluble markers of the inflammatory response (Acute phase reactants: Serum ferritin, C Reactive Protein). Measurement time: at baseline and, at weeks 9 and 17. 7) Infections (Frequency of infectious events (Number of infectious events recorded); Severity of the infectious event (Use of antibiotic treatment and the management of the patient according to their clinical severity, it will be classified as: outpatient, open room hospitalization, ICU (intensive care unit) hospitalization, ICU hospitalization with septic shock); Location of the infectious event (It will be classified as: infection of the vascular access: AVF (internal arterio‐venous fistula), permanent catheter, transient catheter; infection in another specific organ (upper respiratory, lower respiratory (pneumonia, bronchopneumonia), genitourinary, digestive, CNS (central nervous system) or other; Systemic infection. If the result of the blood culture is positive and ICU admission occurs); Etiology of the infectious event (Type of causing germ: bacterial, viral, fungal, parasitic or other); Use of antibiotic treatment (Yes / No); Route of administration of the antibiotic to treat the infection (It will be classified as: systemic (oral, Intramuscular, subcutaneous, intravenous, other) or No (local)); Hospital admission time (Time between admission date and hospital discharge date)). Measurement time: Measurement time: at baseline and, at weeks 9 and 17. 8) Adverse clinical events‐AE (They will be measured as: ‐Occurrence of AE (Yes, No), ‐Description of the AE (name of the event), ‐Intensity of the AE (mild, moderate, severe), ‐Relation of causality (no related, doubtful, possible, probable, definitive) ‐Measures taken (None, Administration of some pharmacological therapy, Addition of a non‐pharmacological therapy, Exit of the study, Hospitalization / prolongation of hospitalization), ‐Result (Fully resolved, Solved with sequelae, Conditions in improvement, Present and unchanged condition, Worsening, Death caused by this event)). Measurement time: at baseline and, at weeks 9 and 17.