Stage 5 Chronic Kidney Disease under an iterated hemodialysis regimen
Conditions
Interventions
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
Renal Dialysis
Injections, Subcutaneous
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: 1) Patients who have received treatment with HEBERTRANS in the previous three months. 2) Patients with known hypersensitivity to any component of the formulation. 3) Patients with acute allergic states or history of severe allergic reactions. 4) Patients under immunosuppressive treatment at the time of the study. 5) Patients with hemoglobin less than or equal to 90 g / L. 6) Patients with uncontrolled intercurrent diseases, acute infections with concomitant febrile symptoms, symptomatic congestive heart failure, unstable angina pectoris, among others. 7) Patients in kidney transplant program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Cuba
Contacts
Public ContactIvis Mendoza Hernandez
National Coordinating Center for Clinical Trials (CENCEC).
Outcome results
None listed