Post –authorizacion study on safety and effectiveness of ior®EPOCIM of 3000 UI y 5000 UI in patients with symptomatic anemia associated chronic kidney disease undergoing dialysis.

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:

ior®EPOCIM 3K/5K ERC /2024

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM)

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:

Only approved by Ethics Committees

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 :

Second degree specialist in nephrology

Affiliation:

Institute of Nephrology “Dr Abelardo Buch Lopez”

Postal address:

Avenida 26 y Rancho Boyeros, Municipio Plaza de la Revolucion

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-53888120

Email address:

perezolivajorge955@gmail.com [1]

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:

02/11/2026

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

Health condition keyword:

Intervention(s):

Ior®EPOCIM group (Experimental): ior®EPOCIM (in bulbs 3000 UI o 5000 UI) in regular doses of 30 to 100 UI/kg/weekly, intravenously (IV) or subcutaneously (SC) for a year.

Intervention code:

Erythropoietin

Injections, Intravenous

Injections, Subcutaneous

Intervention keyword:

ior® EPOCIM

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):

Security variables: 1. Exposure to ior®EPOCIM (average dose received in the study). Measurement time: monthly during the year of treatment. 2. Type of adverse event (AE). Determined by preferred terms and affected organ systems, by patient and number of AEs. Measurement time: monthly during the year of treatment. 3. AE intensity (expressed according to the adverse event intensity categories of the Cuban Pharmacovigilance System and WHO definitions). Measurement time: monthly during the year of treatment.

Key secondary outcomes:

1. Transfusion requirements (Numbers of the red blood cell transfusions received). Measurement time: monthly during the year of treatment. 2. Hemoglobin level (Value expressed in g/dL). Measurement time: monthly during the year of treatment. 3. Hematocrit level (Value expressed in %). Measurement time: monthly during the year of treatment.

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. Subjects diagnosed with CKD undergoing hemodialysis and meeting the criteria for recombinant human erythropoietin (rhEPO) use, whether currently under treatment (prevalent cases) or treatment-naïve (incident cases). 2. Adult patients (> 18 years) 3. Of either sex 4. Patients who provide written consent to participate in the study.

Exclusion criteria:

1. Cancer patients 2. Patients with uncontrolled hypertension 3. Patients with hypersensitivity to human albumin

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:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

100

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:

Giselle

Last Name:

Saurez Martínez

Specialty:

Specialist in Comprehensive General Medicine and Pharmacology

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 esq. 15. Atabey. Playa.

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+537-2717933 ext. 3653. mobile: +53-58179946

Email :

giselle@cim.sld.cu [2]

saurezgiselle@gmail.com [3]

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:

Second degree specialist in nephrology

Affiliation:

Institute of Nephrology “Dr Abelardo Buch Lopez”

Postal Address:

Avenida 26 y Rancho Boyeros, Municipio Plaza de la Revolucion

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-53888120

Email :

perezolivajorge955@gmail.com [1]

Research Ethics Committees

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

Name of Research Ethics Committees:

Institute of Nephrology “Dr Abelardo Buch Lopez”

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

10/04/2026

Postal address of Ethic Committee :

Avenida 26 y Rancho Boyeros, Municipio Plaza de la Revolución. CP:10600, La Habana, Cuba.

Telephone:

+53-52427217

Correo electrónico:

alvarezyanet@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

27/10/2028

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:

RPCEC00000487

Date of Registration in Primary Registry:

26/10/2026

Record Verification Date:

2026/10/26

Next update date:

2027/10/26

Link to the spanish version:

Click here [4]