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 and effectiveness of ior®EPOCIM of 3000 UI y 5000 UI in patients with symptomatic anemia associated chronic kidney disease undergoing dialysis.
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.
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
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:
Recruitment status Section to complete information about the recruitment status and the date of first enrolment subject
Date of first enrollment:
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:
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
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.
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
Study design Section to complete information about the characteristics of the study design.
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
Specialty:
Specialist in Comprehensive General Medicine and Pharmacology
Affiliation:
Center of Molecular Immunology (CIM)
Postal Address:
Calle 216 esq. 15. Atabey. Playa.
Telephone:
+537-2717933 ext. 3653. mobile: +53-58179946
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.
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
Data Sharing Section to complete the data related to the data sharing plan.
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 date of Ethic Committee:
Postal address of Ethic Committee :
Avenida 26 y Rancho Boyeros, Municipio Plaza de la Revolución. CP:10600, La Habana, Cuba.
Correo electrónico:
alvarezyanet@infomed.sld.cu
About study completion Section to complete the data related to the study completion.
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).
Date of Registration in Primary Registry:
Record Verification Date:
Link to the spanish version:
Versión para impresión