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

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000123
• Date of registration: 11/11/2011
• Primary sponsor: CIMAB-Center of Molecular Immunology (CIM)
• Public title: Effectiveness and safety of ior®EPOCIM in Chronic Kidney Disease patients in pre-dialysis.
• Scientific title: Effectiveness and safety of ior®EPOCIM in Chronic Kidney Disease patients in pre-dialysis.
• Date of first enrolment: 19/05/2011
• Target sample size: 425
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000123-En
• Study type: Interventional
• Study design: Randomization: Nonrandomized Trial Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Patricia Piedra
• Affiliation: CIMAB S.A

• Name: Patricia Piedra
• Affiliation: CIMAB S.A.

Key inclusion & exclusion 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: 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.

Age minimum: 18 years
Age maximum: No limit
Gender: Both

Health Condition(s) or Problem(s) studied

Anemia secondary to Chronic Kidney Disease

Intervention(s)

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 recommended. This procedure can be repeated every 4 weeks to a maximum of 150 U/kg/doses, generally in three doses. The treatment will be for a year.

Primary Outcome(s)

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

Secondary Outcome(s)

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).

Secondary ID(s)

IIC RD-EC1112

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable