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

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:

Effectiveness and Safety of ior EPOCIM in patients with Chronic Renal Failure on dialysis methods (hemodialysis or peritoneal dialysis).

Secondary indentifying numbers:

IIC RD-091

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology(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 :

03/08/2007

Reference number:

24-076-07-B

Principal investigator

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

First name:

MD.Jorge F.Pérez-Oliva Díaz.Second degree specialist in 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:

Havana City,Hermanos Ameijeiras Hospital,MD.Amaury Lorenzo Clemente.Second degree specialist in Nephrology. Havana City,Miguel Enríquez Hospital,MD.Randolfo Torres Martínez.First degree specialist in Nephrology. Pinar Del Rio,Abel Santamaría Hospital,MD.Félix Eduardo Lugo López.First degree specialist in Nephrology. Villa Clara,Arnaldo Milián Hospital,MD.Eduviel Ramos Cárdenas.First degree specialist in Nephrology.

Research ethics committees:

Havana City,Hermanos Armeijeiras Hospital,December 20,2006. Havana City,National Institute of Nephrology,December 21,2006. Habana City,Miguel Enrique Hospital,January 19,2007. Pinar del Rio,Abel Santamaria Hospital,March 15,2007. Villa Clara,Arnaldo Milian Hospital,Febrary 12,2007.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

01/03/2007

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 Insufficiency.

Intervention(s):

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

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

Key secondary outcomes:

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.

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:

none

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.

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:

Non-randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

4

Target sample size:

621

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

Zip Code:

11600

Telephone:

(537)271-50-57 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:

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

City:

Havana City

País:

Cuba

Zip Code:

11600

Telephone:

(537)271-50-57 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:

RPCEC00000082

Date of Registration in Primary Registry:

2009-07-10

Record Verification Date:

2009-07-06 20:00

Link to the spanish version:

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Ensayos Registrados

Proceso de Registro

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

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