Exploratory study of BMT EV to stimulate immune response in patients with CKD-5 on iterated hemodialysis

Evaluation of the effect and safety of BIOMODULIN T® for the stimulation of the immune response in patients with Stage 5 Chronic Kidney Disease under an iterated hemodialysis regimen. Exploratory study. (COVID-19)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000316

Enrollment

Registered

2020-05-28

Start date

2020-07-02

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune response in patients with CKD-5 on an iterated hemodialysis regimen COVID-19 SARS-CoV2

Interventions

Group 1 Experimental: Biomodulin T, 1 bulb (3mg / 3mL), twice a week, intramuscularly (IM) for 6 weeks Group 2 Control: (Biomodulin T will not be administered)

Immunologic Factors

Injections Intramuscular

Biomodulin T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Hemogram (Hemoglobin, Hematocrit, Leukogram with differential and Platelets). Measurement time: at baseline and, 8 weeks after randomization Lymphocyte subpopulations (CD3+/CD4+, CD3+/CD8+, CD19+ and, CD3-/CD56 +). Measurement time: at baseline and, 8 weeks after randomization Igs Quantification (IgA, IgM and, IgG). Measurement time: at baseline and, 8 weeks after randomization Complement Quantification (C3 and C4). Measurement time: at baseline and, 8 weeks after randomization	—

Measure

Time frame

Hemogram (Hemoglobin, Hematocrit, Leukogram with differential and Platelets). Measurement time: at baseline and, 8 weeks after randomization Lymphocyte subpopulations (CD3+/CD4+, CD3+/CD8+, CD19+ and, CD3-/CD56 +). Measurement time: at baseline and, 8 weeks after randomization Igs Quantification (IgA, IgM and, IgG). Measurement time: at baseline and, 8 weeks after randomization Complement Quantification (C3 and C4). Measurement time: at baseline and, 8 weeks after randomization

—

Secondary

Measure	Time frame
Clinical response variables 1. COVID-19 infection (occurrence of complications and mortality). Measurement time: at baseline and, 8 weeks after randomization. 2. Infections (Number (0 to infinity), Type (depending on the organ or system affected), Need for antibiotic treatment (Yes or No), Etiology (Bacterial, Viral, Fungal or Parasitic), Route of administration of antibiotic treatment (Oral and / o Parenteral), Need for hospital admission (Yes or No), Mortality due to infection (Yes or No), Acute phase reactants (C-Reactive Protein and Ferritin)). Measurement time: at baseline and, 8 weeks after randomization. 3. Adverse Events-AE (AE will be classified according to Type (name of AE), Location (Local or Systemic), Time of appearance (immediate or late), Duration (Less than one day or Greater than one day), Previous knowledge (expected or unexpected), Intensity ( Mild, Moderate, or Severe), Consequence (Serious or Not Serious), Causation (Very Probable / Safe, Probable, Possible, Improbable, Unrelated, Not Evaluable / Not Classifiable), Outcome of Adverse Event (Recovered, Not Recovered, Recovered with sequelae, Death or Unknown) and attitude towards the study treatment (Continuation or definitive interruption). Measurement time: during all administrations of the product and, 8 weeks after randomization.	—

Measure

Time frame

Clinical response variables 1. COVID-19 infection (occurrence of complications and mortality). Measurement time: at baseline and, 8 weeks after randomization. 2. Infections (Number (0 to infinity), Type (depending on the organ or system affected), Need for antibiotic treatment (Yes or No), Etiology (Bacterial, Viral, Fungal or Parasitic), Route of administration of antibiotic treatment (Oral and / o Parenteral), Need for hospital admission (Yes or No), Mortality due to infection (Yes or No), Acute phase reactants (C-Reactive Protein and Ferritin)). Measurement time: at baseline and, 8 weeks after randomization. 3. Adverse Events-AE (AE will be classified according to Type (name of AE), Location (Local or Systemic), Time of appearance (immediate or late), Duration (Less than one day or Greater than one day), Previous knowledge (expected or unexpected), Intensity ( Mild, Moderate, or Severe), Consequence (Serious or Not Serious), Causation (Very Probable / Safe, Probable, Possible, Improbable, Unrelated, Not Evaluable / Not Classifiable), Outcome of Adverse Event (Recovered, Not Recovered, Recovered with sequelae, Death or Unknown) and attitude towards the study treatment (Continuation or definitive interruption). Measurement time: during all administrations of the product and, 8 weeks after randomization.

—

Countries

Cuba

Contacts

Public ContactJorge Perez- Oliva Díaz

National Institute of Nephrology “Dr. Abelardo Buch Lopez”

scnefro@infomed.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026