Effectiveness and safety of ior®EPOCIM in Chronic Kidney Disease patients in pre-dialysis.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000123

Enrollment

425

Registered

2011-11-11

Start date

2011-05-19

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia secondary to Chronic Kidney Disease

Interventions

EPOCIM (EPO): 30 U/Kg subcutaneous route during the first 8 weeks, 1-3 times a week according to the investigator criteria. If no response after 8 weeks is obtained, a 25% gradual increase of dose is

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients that fulfill the diagnostic criteria. 2. Patients that give a written consent 3. Patient with age over or equal to 18 years. 4. Patients of both sexes.

Exclusion criteria

Exclusion criteria: 1. Patients with known hypersensitivity to products derived from superior cells or hypersensitivity to human albumin. 2. Pregnant or breastfeeding patients. 3. Patients with other non-renal anemia. 4. Patients with Class III-IV Heart Failure, according to the New York Heart Association Classification. 5. Patients with oncologic disease diagnose.

Design outcomes

Primary

Measure	Time frame
Hematologic response (Values of Hemoglobin in g/l and Hematocrit in %). Measuring time: monthly until the end of the treatment (1 year).	—

Secondary

Measure	Time frame
Time for correction of anemia. Measuring time: monthly until the end of the treatment (1 year). Transfusion requirements (Yes/No). Measuring time: monthly until the end of the treatment (1 year). Total of transfusion (Number of the transfusions). Measuring time: monthly until the end of the treatment (1 year). Progression of kidney damage (creatinine values and glomerular filtration theory). Measuring time: monthly until the end of the treatment (1 year). Left ventricular function (Mass of left ventricular, Mass index, Diameter of the wall of the left ventricular posterior, LV ejection fraction, stroke volume and diastolic volume). Measuring time: at the end of the treatment (1 year). Quality of life (SF-36 questionnaire). Measuring time: at the end of the treatment (1 year) Adverse events (AE). Measuring time: monthly until the end of the treatment (1 year) -Description of AE. Name of the event -Duration of AE. (Difference between the beginning date and the finish date of the event) -Treatment applied (Treatment applied) -Intensity of AE (Slight, Moderate, Severe) -Severity of AE (Severe/Serious, Not severe/Not serious) -Relationship causality (Definitive, Very likely, Probable, Possible, Not related, Unknown) -Attitude to study treatment (Unchanged, Dose modification,Temporary discontinuation of study treatment, Permanent discontinuation of study treatment) -Outcome of AE (Recovered, Improved, Persist, Sequelae, Death) Laboratory (hematologic [total leukocyte, platelet count, reticulocyte count, serum iron] and biochemistry [Uric acid, urea, glucose, albumin, TGP, TGO). Measuring time: monthly until the end of the treatment (1 year).	—

Measure

Time frame

Time for correction of anemia. Measuring time: monthly until the end of the treatment (1 year). Transfusion requirements (Yes/No). Measuring time: monthly until the end of the treatment (1 year). Total of transfusion (Number of the transfusions). Measuring time: monthly until the end of the treatment (1 year). Progression of kidney damage (creatinine values and glomerular filtration theory). Measuring time: monthly until the end of the treatment (1 year). Left ventricular function (Mass of left ventricular, Mass index, Diameter of the wall of the left ventricular posterior, LV ejection fraction, stroke volume and diastolic volume). Measuring time: at the end of the treatment (1 year). Quality of life (SF-36 questionnaire). Measuring time: at the end of the treatment (1 year) Adverse events (AE). Measuring time: monthly until the end of the treatment (1 year) -Description of AE. Name of the event -Duration of AE. (Difference between the beginning date and the finish date of the event) -Treatment applied (Treatment applied) -Intensity of AE (Slight, Moderate, Severe) -Severity of AE (Severe/Serious, Not severe/Not serious) -Relationship causality (Definitive, Very likely, Probable, Possible, Not related, Unknown) -Attitude to study treatment (Unchanged, Dose modification,Temporary discontinuation of study treatment, Permanent discontinuation of study treatment) -Outcome of AE (Recovered, Improved, Persist, Sequelae, Death) Laboratory (hematologic [total leukocyte, platelet count, reticulocyte count, serum iron] and biochemistry [Uric acid, urea, glucose, albumin, TGP, TGO). Measuring time: monthly until the end of the treatment (1 year).

—

Countries

Cuba

Contacts

Public ContactPatricia Piedra

CIMAB S.A

patrip@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026