Therapeutic Equivalence between ior EPOCIM and EPO without albumin, for patients with Chronic Renal failure on Peritoneal dialysis methods.(Hemodialysis or peritoneal dialysis).

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000077
• Date of registration: 03/07/2009
• Primary sponsor: Center of Molecular Inmunology(CIM)
• Public title: Therapeutic Equivalence between ior EPOCIM and EPO without albumin, for patients with Chronic Renal failure on Peritoneal dialysis methods.(Hemodialysis or peritoneal dialysis).
• Scientific title: Therapeutic Equivalence between ior EPOCIM and EPO without albumin, for patients with Chronic Renal failure on Peritoneal dialysis methods.(Hemodialysis or peritoneal dialysis).
• Date of first enrolment: 01/10/2004
• Target sample size: 60
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000077-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Active Assignment: Parallel 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 who have given their consent to participate in the study in writing. 2.Patients aged between 18 and 70 years. 3.Treatment with stable dialysis patients for a minimum period of 6 months. 4.Patients who have received ior EPOCIM for the treatment of anemia associated with CRF and maintain levels equal to or greater than 30% of hematocrit and hemoglobin equal to or greater than 10g/dL with a stable dose of EPOCIM for 3 months. 5.Includes patients of both sexes in the study.
Exclusion criteria: 1.Pregnant patients,nursing or women of childbearing age who are not using contraception. 2.Patients with uncontrolled arterial hypertension. 3.Patients receiving treatment with immunosuppressive agents. 4.Patients with a history of epilepsy. 5.Patients with sepsis or active infection. 6.Patients with active acute or chronic inflammatory. 7.Patients who have been transfused in the month prior to the assessment for inclusion. 8.Patients with hematologic diseases. 9.Patients with Severe Hyperparathyroidism. 10.Patients with a diagnosis of malignancy or therapy Anticancer. 11.Renal transplant patients scheduled to coincide with period of study. 12.Patients with known hypersensitivity to products derived from mammalian cells. 13.Psychiatric patients with decompensated. 14.Patients with alcoholism or drug addiction.

Age minimum: 18 years
Age maximum: 70 years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Renal Failure.

Intervention(s)

One group will receive EPO W/A and the other will receive EPOCIM:(20-200UI/kg body weight),corresponding 1:1(iorEPOCIM:EPO W/A). Both products will be administered by the usual route(subcutaneous or intravenous). Both groups received treatment for a period of 12 weeks,with a frequency of 3 times weekly after each dialysis session.

Primary Outcome(s)

Hemoglobin/hematocrit (g/dl),measurement time 12 weeks.

Secondary Outcome(s)

Blood chemistry: creatinine, glucose, TGP, TGO, albumin, calcium, phosphate, ferritin, transferrin, serum iron, measurement time 12 weeks. Hematology: Counting of Reticulocytes, leukocytes, erythrocytes, measurement time 12 weeks. Safety assessment, number of transfusions, dose and frequency of administration of erythropoietin, Measuring time: 12 weeks. Occurrence of any adverse events (AE) in the subject, yes/no, Measuring time: 12 weeks. Duration of Adverse Event (AE), in minutes or days, measuring time: 12 weeks. Intensity of adverse events (AE),Slight, Moderate, Severe, Very severe, measuring time:12 weeks. Causal relationship, very likely, likely, possible, remote, Measuring time: 12 weeks. Attitude to treatment, no change, modification of dose, Interrupted temporary interruption ultimately, Measuring time: 12 weeks. Result of the treatment to counteract the adverse events (AE), recovered, improved, persisted, sequelae, measurement time: 12 weeks. Antibodies antiEPO, the values recorded according to the determinations made for each patient, measurement time :12 weeks.

Secondary ID(s)

IIC RD-EC068

Source(s) of Monetary Support

Goverment found

Secondary Sponsor(s)

No proceed