Effectiveness and Safety of ior EPOCIM in patients with Chronic Renal Failure on dialysis methods.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000082
• Date of registration: 10/07/2009
• Primary sponsor: Center of Molecular Immunology(CIM)
• Public title: Effectiveness and Safety of ior EPOCIM in patients with Chronic Renal Failure on dialysis methods.
• Scientific title: Effectiveness and Safety of ior EPOCIM in patients with Chronic Renal Failure on dialysis methods (hemodialysis or peritoneal dialysis).
• Date of first enrolment: 01/03/2007
• Target sample size: 621
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000082-En
• Study type: Interventional
• Study design: Randomization: Nonrandomized Trial Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria: 1.Patients with inform consent signed. 2.Patients with stable dialysis treatment at least of 3 months prior. 3.Patients who are receiving ior EPOCIM for the treatment of anemia associated with CRF. 4.Age less than 18 years. 5.To be included in the study patients of both sexes.
Exclusion criteria: 1.Patients with known hypersensitivity to products derived from cells above or hypersensitivity to human albumin. 2.Patients pregnant or breastfeeding.

Age minimum: 18 years
Age maximum: none
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Renal Insufficiency.

Intervention(s)

EPOCIM:25-200 IU/kg(subcutaneously)3 times per week for 12 months.

Primary Outcome(s)

Hemoglobin(g/dl), Hematocrit(%), Assessment of response (Optimal, Good, Fair, Poor), Response Type (Maintain, Increase, Decrease). Measurement time: 12 months.

Secondary Outcome(s)

Biochemical parameters:The values recorded by the units set for each,measurement time:12 months. Occurrence of any adverse event in the subject:yes/no,measurement time:12 months. Duration of the adverse event:Dates of commencement and completion of the adverse event,measurement time:12 months. Intensity of adverse event:Slight,Moderate,Severe,Very severe,measurement time:12 months. Causal relationship:Very likely, likely, possible, remote,measurement time:12 months. Attitude to treatment:No change, modification of dosage, temporary interruption final,measurement time:12 months. Result of the treatment applied to counter adverse event:Recovered,Improved,sequelae persists,measurement time:12 months. Indicators of Quality of Life,will assess the improvement of the parameters of quality of life through Fact-An Inquiry,measurement time:12 months.

Secondary ID(s)

IIC RD-091

Source(s) of Monetary Support

Goverment found

Secondary Sponsor(s)

No proceed.