Exploratory study of BMT EV to stimulate immune response in patients with CKD-5 on iterated hemodialysis
- Conditions
- Immune response in patients with CKD-5 on an iterated hemodialysis regimenCOVID-19SARS-CoV2Kidney Failure, ChronicRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesCoronavirus InfectionsCoronaviridae Infections
- Registration Number
- RPCEC00000316
- Lead Sponsor
- Centro Nacional de Biopreparados (BioCen)
- Brief Summary
Treatment with Biomodulina T® stimulates the immune response and decreases respiratory infections in older adults. Its effect and safety in patients with Chronic Kidney Disease is stage 5 in iterated hemodialysis regimen (CKD-5 in HdI) were unknown. The purpose of this study was to evaluate the effect and safety of Biomodulina T® for the stimulation of the immune response in patients with CKD-5 in LHD, from a preventive scenario against the viral disease COVID-19. An exploratory, multicenter, open, controlled, randomized clinical trial was conducted. The study was carried out in 20 patients attended in the outpatient hemodialysis service of the Hospital Hermanos Ameijeiras with a diagnosis of CKD-5 in LHD, over 18 years of age, who gave their written consent and met the selection criteria, who were randomized 1 :1 (Group 1 or study 10 patients and Group 2 or control 10 patients). Patients with acute allergic states or a history of severe allergic reactions, patients with primary or secondary glomerulopathies, patients with hemoglobin less than 99 g/L, and patients with uncontrolled intercurrent diseases such as: acute infections with concomitant febrile symptoms, heart failure were excluded. symptomatic congestive and unstable angina pectoris. The patients in the Study Group received Biomodulina T® in a scheme of 1bbo (3mg) IM twice a week for 6 weeks and those in the control group did not receive this treatment. To determine the behavior of cellular (lymphocyte subpopulations) and humoral (Immunoglobulins and Complement) immunological parameters, all study patients underwent blood draws for the initial evaluation (T0), and a second and final draw (T7). which corresponded to one week after finishing the treatment in the case of the patients in the study group. All patients were followed up for a period of 8 weeks, determining at this time: the changes in relation to infections with the 8 weeks prior to starting treatment, the incidence of COVID-19 and the safety of the product under investigation when identifying and classifying the adverse events that occurred in the patients, during the course of the study. In both groups, male sex and black skin color prevailed. Meanwhile, in the Study Group the mean age was 58.2 ± 7.4 years and in the Control Group 49.5 ± 14.5 years. Due to the characteristics described, the demographic variables are homogeneous and comparable. A total of 120 intravenous applications (360 mg) were administered, 100% of those planned. In patients with CKD-5 in LHD, according to cellular and humoral immunological parameters in both groups, inflammation predominates over immunosuppression. Treatment with Biomodulin T showed evidence of its influence in slowing down the decline in naïve T lymphocytes and the progression of inflammation in treated patients. A low incidence of infections was evidenced, but the short evaluation time before and after treatment prevents an adequate weighting in terms of infections in both study groups. During the study, none of the patients was diagnosed with COVID-19, neither those in the control group nor those in the treatment group, therefore this effect cannot be attributed solely to Biomodulina T. 5. The administration of intravenous Biomodulina T® was safe and well tolerated by patients, with very few related adverse events appearing, none of which caused treatment interruption. Treatment with Biomodulina T® had a lower therapeutic effect than expected, although it maintained a narrow safety profile, which is why it is suggested that other studies be carried out exploring other dose schedules, longer evaluation times and a larger sample of patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
1. Patients who meet the diagnostic criteria
2. Any gender and skin color and age over 18 years.
3. Patients who express their written consent, to participate in the study
1. Patients who have received treatment with BIOMODULINA T® 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 with primary or secondary glomerulopathies.
5. Patients with immunosuppressive treatment.
6. Patients with hemoglobin less than or equal to 99 g / L
7. Patients with uncontrolled breakthrough diseases including, but not limited to: acute infections with concomitant febrile illness, symptomatic congestive heart failure, unstable angina pectoris.
8. Patients with a previous diagnosis of COVID-19 infection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hemogram (Hemoglobin, Hematocrit, Leukogram with differential and Platelets). Measurement time: at baseline and, 8 weeks after randomization<br>Lymphocyte subpopulations (CD3+/CD4+, CD3+/CD8+, CD19+ and, CD3-/CD56 +). Measurement time: at baseline and, 8 weeks after randomization<br>Igs Quantification (IgA, IgM and, IgG). Measurement time: at baseline and, 8 weeks after randomization<br>Complement Quantification (C3 and C4). Measurement time: at baseline and, 8 weeks after randomization<br>
- Secondary Outcome Measures
Name Time Method