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

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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:

Secondary indentifying numbers:

IIC RD-EC068

Issuing authority of the secondary identifying numbers:

Center of Molecular Inmunology(CIM)

Source(s) of monetary or material support:

Goverment found

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:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

14/07/2004

Reference number:

1371/05.012.04B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

MD.Jorge F.Perez-Oliva Diaz.Second degree Nephrology.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

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:

Cuba

Clinical sites:

No proceed

Research ethics committees:

Havana City,National Institute of Nephrology,March 25,2004.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

01/10/2004

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:

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.

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):

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

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

70 years

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

3

Target sample size:

60

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

First Name:

MD.Patricia

Last Name:

Piedra

Affiliation:

CIMAB S.A

Postal Address:

206 No.1926 e/19 and 21 Atabey,Playa

City:

Havana City

País:

Cuba Cuba

Zip Code:

11600

Telephone:

537-271-5057 Ext.111

Email :

patrip@cim.sld.cu

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.

First Name:

MD.Patricia

Last Name:

Piedra

Affiliation:

CIMAB S.A

Postal Address:

2O6 No.1926 e/ 19 and 21 Atabey,Playa

City:

Havana City

País:

Cuba

Zip Code:

11600

Telephone:

537-271-5057 Ext.111

Email :

patrip@cim.sld.cu

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).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000077

Date of Registration in Primary Registry:

2009-07-03

Record Verification Date:

2009-07-23 20:00

Link to the spanish version:

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Proceso de Registro

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

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