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

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-EC1112

Issuing authority of the secondary identifying numbers:

CIMAB-Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Government funds

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 :

20/12/2010

Reference number:

24-183-10-B

Principal investigator

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

First name:

Jorge F. Pérez Oliva-Díaz, MD. 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 [1]

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, Hermanos Ameijeiras Clinical Surgical Hospital. Guillermo Guerra Bustillo, MD. First degree specialist in Nephrology. Havana, Miguel Enriquez Hospital. Victor Remon Blanco, MD. First degree specialist in Nephrology. Havana, Carlos J. Finlay Hospital. Mireya Martinez Felipe, MD. First degree specialist in Nephrology. Havana, CIMEQ Hospital. Julio Valdivia Arencibia, MD. Second degree specialist in Nephrology. Pinar del Rio, Abel Santamaria Hospital. Felix Eduardo Lugo Lopez, MD. First degree specialist in Nephrology. Villa Clara, Arnaldo Milian Hospital. Jorge Lopez Romero, MD. Second degree specialist in Nephrology. Matanzas, Faustino Perez Hospital. Vivian Ruano Quintero, MD. First degree specialist in Nephrology. Sancti Spiritus, Camilo Cienfuegos Hospital. Remberto Cruz Perez, MD. First degree specialist in Nephrology. Granma, Celia Sanchez Manduley Hospital. Emilio Rodriguez Lopez, MD. First degree specialist in Nephrology.

Research ethics committees:

National Institute of Nephrology “Abelardo Bush López”, August 17, 2010 Hermanos Ameijeiras Clinical Surgical Hospital, September 6 , 2010 Miguel Enríquez Hospital, July 23, 2010 Carlos J. Finlay Hospital. June 24, 2010 CIMEQ Hospital Abel Santamaría Hospital, April 20, 2010 Arnaldo Milián Hospital, May 17, 2010 Faustino Pérez Hospital, Camilo Cienfuegos Hospital, September 29, 2010 Celia Sanchez Manduley Hospital, July 6, 2010

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

19/05/2011

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:

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.

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):

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

Key secondary outcomes:

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).

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:

No limit

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.

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:

Target sample size:

425

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:

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 [2]

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:

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 [2]

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:

RPCEC00000123

Date of Registration in Primary Registry:

2011-11-11

Record Verification Date:

2011-10-17 20:00

Link to the spanish version:

Click here [3]