Transfer factor in Chronic Kidney Disease

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Evaluation of the effect and safety of HEBERTRANS on the immune response in patients with Stage 5 Chronic Kidney Disease under an iterated hemodialysis regimen, from a preventive scenario against infectious diseases.

Secondary indentifying numbers:

IG/FTI/ERC/2001

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana. Ministry of Public Health, Cuba.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Jorge

Midle name:

Francisco

Last name:

Perez- Oliva Diaz

Medical Specialty :

Doctor of Medical Sciences; 2nd degree specialist in Nephrology.

Affiliation:

National Institute of Nephrology “Dr. Abelardo Buch Lopez ".

Postal address:

Ave. 26 y Boyeros. Plaza de la Revolucion

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

+53-78812413

Email address:

scnefro@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

07/08/2020

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Stage 5 Chronic Kidney Disease under an iterated hemodialysis regimen

Health condition(s) code:

Kidney Failure, Chronic

Renal Insufficiency, Chronic

Renal Insufficiency

Kidney Diseases

Urologic Diseases

Intervention(s):

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.

Intervention code:

Transfer Factor

Renal Dialysis

Injections, Subcutaneous

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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.

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

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:

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

20

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Ivis

Last Name:

Mendoza Hernandez

Specialty:

Bachelor of Pharmaceutical Sciences; Master in Pharmacology and Clinical Trials.

Affiliation:

National Coordinating Center for Clinical Trials (CENCEC).

Postal Address:

Calle 5ta A e/ 60 y 62, Miramar, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72048739

Email :

ivis@cencec.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Jorge

Middle Name:

Francisco

Last Name:

Perez- Oliva Diaz

Specialty:

Doctor of Medical Sciences; 2nd degree specialist in Nephrology.

Affiliation:

Nephrology Institute "Dr. Abelardo Buch Lopez"

Postal Address:

Ave. 26 y Boyeros. Plaza de la Revolucion

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

+53-78812413

Email :

scnefro@infomed.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Nephrology Institute "Dr. Abelardo Buch Lopez"

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

21/07/2020

Postal address of Ethic Committee :

26 Avenue and Boyeros. Plaza de la Revolución, Havana, Cuba. PB. 10600

Telephone:

+53-78812413

Email:

-

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

0

Study completion date:

14/06/2021

Date of available results:

15/07/2021

Date of first publication:

15/12/2021

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000328

Date of Registration in Primary Registry:

06/08/2020

Record Verification Date:

2020/08/06

Next update date:

2021/08/06

Link to the spanish version:

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Transfer factor in Chronic Kidney Disease

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