Effect and safety of the use of Viusid® on the quality of life of patients with Chronic Kidney Disease on Hemodialysis.

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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:

Secondary indentifying numbers:

CAT-2022-4

Issuing authority of the secondary identifying numbers:

National coordinator center of clinical trial (CENCEC)

Source(s) of monetary or material support:

Catalysis Laboratories, SL.

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:

Institute of Nutrition and Hygiene of food(INHA)

Reference number:

In process

Principal investigator

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

First name:

Dagoberto

Last name:

Semanat Vaillant

Medical Specialty :

1st degree specialist in Nephrology

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal address:

San Lazaro 701 corner Belascoain, Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78765138

Email address:

dago.semanat@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:

Havana, Institute of Nephrology (INEF), PhD. Esther Ibars Bolaños, Specialist in 1st and 2nd degree of Nephrology, Assistant Professor

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

05/04/2023

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:

Chronic Kidney Disease

Health condition(s) code:

Renal Insufficiency, Chronic

Renal Insufficiency

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Intervention(s):

Experimental group: Viusid (1 vial, 30 mL), once a day, orally in single doses, for 6 months. The patients function as their own historical control.

Intervention code:

Dietary Supplements

Administration, Oral

Intervention keyword:

Viusid

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):

Quality of life (QOL Questionnaire (SF-36). Measurement time: at the beginning and at month 6.

Key secondary outcomes:

1-Presence and severity of symptoms and signs (palliative care symptom scale, POS-S Renal). Measurement time: at baseline and at month 6. 2-Nutritional status (hematological and biochemical parameters: a-hemoglobin, b-hematocrit, c-total leukocyte count, d-lymphocytes, e-prealbumin, f-albumin, g-total protein, h-cholesterol, i-creatinine, urea). Measurement time: at the beginning and at month 6. 3-Dynamic parameters (weight variation (pounds and/or kg) and BMI (kg/m2). Measurement time: at the beginning, month 3 and months 6. 4-Parameters of the inflammatory state (a-Hemogram indices (of 5 parts), b-Prealbumin, c-Albumin, d-C-reactive protein, e-Transferrin, f-Erythropoietin resistance index, g-Neutrophil/lymphocyte index, Platelet/lymphocyte index). Measurement time: beginning, month 3 and month 6. 5-Safety (AE of the study: intensity, severity, causality, attitude towards treatment and result. Questioning, physical examination and batch of the PI. Measurement time Month 3 and month 6.

Selection criterias

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

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

Inclusion criteria:

1-Patients who meet the diagnostic criteria. 2-Patients who give their consent 3-Patients 19 years or older 4-Patients with 3 months or more on hemodialysis.

Exclusion criteria:

1-Patients with active infection at the time of inclusion. 2-Pregnant or lactating patients. 3-Patients with a diagnosis of active immunological disease or mental disability. 4-Patients who are under treatment with chemotherapy or radiotherapy. 5-Patients with known hypersensitivity to products similar to Viusid® oral solution. 6-Patients who are receiving another investigational product.

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:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Historical

Study design:

Single group

Phase:

2

Target sample size:

60

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:

MSc in Clinical Trials

Affiliation:

National Coordinating Clinical Trials Center (CENCEC)

Postal Address:

5ta A e/ 60 y 62, Miramar

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72164227

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:

Esther

Last Name:

Ibars Bolaños

Specialty:

Specialist in 1st and 2nd degree of Nephrology. Assistant Professor

Affiliation:

Institute of Nephrology

Postal Address:

26th Avenue and Rancho Boyeros

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

+53-78811586

Email :

esthervictoria@infomed.sld.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Hermanos Ameijieras Clinical Surgery Hospital

Institute of Nephrology

Status of evaluation:

In evaluation

Approved

Status of evaluation date of Ethic Committee:

07/02/2023

20/02/2023

Postal address of Ethic Committee :

San Lazaro 701 esq. Belascoain, Centro Habana, Havana, Cuba, ZC 10400

Avenida 26 and Rancho Boyeros, Havana, Cuba, ZC 10600

Telephone:

+53-78761000

+53-78811586

Email:

hha@infomed.sld.cu

esthervictoria@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

21/11/2023

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:

RPCEC00000420

Date of Registration in Primary Registry:

27/03/2023

Record Verification Date:

2023/03/27

Next update date:

2024/03/27

Link to the spanish version:

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Registered Trials

Registration process

Effect and safety of the use of Viusid® on the quality of life of patients with Chronic Kidney Disease on Hemodialysis.

About the RPCEC

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