Post–authorizacion study on safety in sentinel sites in adult patients with 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:

Post –authorizacion study on safety in sentinel sites in adult patients with chronic kidney disease undergoing dialysis.

Secondary indentifying numbers:

ior®EPOCIM (new production) 2K-4K-ERC/2025

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

Country:

Cuba

Zip Code:

10600

Telephone:

+53-53888120

Email address:

perezolivajorge955@gmail.com

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, Hermanos Ameijeiras Clinical-Surgical Hospital, Dagoberto Semanat Vaillant, MD., First degree specialist in nephrology

Havana, Dr. Salvador Allende Clinical-Surgical Teaching Hospital, Amarilis Platero Diaz, MD.,First degree specialist in nephrology

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

19/10/2026

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 2000 UI, 4000 UI o 10 000 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):

Serious adverse reactions (Exposure dose and dose range, specifically for adverse events of interest, such as: severe hypertension, acute myocardial infarction, stroke, thromboembolism, and death). Measurement time: up to one year of treatment.

Key secondary outcomes:

1-Hemoglobin level at the time of severe RAM-Adverse drug reaction (Expressed in g/dl). Measurement time: at the time of the adverse drug reaction during the year of treatment. 2-Hematocrit level at the time of severe RAM (Expressed in %). Measurement time: at the time of the adverse drug reaction during the year of treatment. 3-Transfusions (number of transfusions received). 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.Diagnosis of Chronic Kidney Disease in dialysis program (hemodialysis or peritoneal dialysis). 2. Adult patients (> 18 years). 3. Initiation of treatment with new production erythropoietin or change from another erythropoietin to this within the last 30 days. 4. Signed informed consent.

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:

NA

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 Martinez

Specialty:

Specialist in Comprehensive General Medicine and Pharmacology

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle216 esq. 15. Atabey. Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72717933 ext. 3653. mobile: +53-58179946

Email :

giselle@cim.sld.cu

saurezgiselle@gmail.com

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

Country:

Cuba

Zip Code:

10600

Telephone:

+53-53888120

Email :

perezolivajorge955@gmail.com

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”

Hermanos Ameijeiras Clinical-Surgical Hospital

Dr. Salvador Allende Clinical-Surgical Teaching Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

11/02/2026

01/09/2026

13/05/2026

Postal address of Ethic Committee :

Avenida 26 y Rancho Boyeros, Municipio Plaza de la Revolucion. ZC: 10600, Havana, Cuba.

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

Calle Calzada del cerro #1551 esq. Domínguez, Cerro. ZC: 12000, Havana, Cuba.

Telephone:

+53-52427217

+53-53834650

+53-53256989

Email:

alvarezyanet@infomed.sld.cu

bertglezm@infomed.sld.cu

raisa.baguer@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:

RPCEC00000486

Date of Registration in Primary Registry:

08/10/2026

Record Verification Date:

2026/10/08

Next update date:

2027/10/08

Link to the spanish version:

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Post–authorizacion study on safety in sentinel sites in adult patients with chronic kidney disease undergoing dialysis

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