EPANEM-III

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:

Anemia treatment with Recombinant Human Erythropoietin in patients with Chronic Kidney Disease, pre-dialysis phase.

Secondary indentifying numbers:

IG/EPI/CP/0405

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Ministry of Public Health, CUBA

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:

Only approved by Ethics Committees

Principal investigator

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

First name:

Jorge

Midle name:

Last name:

Perez-Oliva Diaz

Medical Specialty :

Specialist 2nd. Nephrology Degree

Affiliation:

National Institute of Nephrology “Abelardo Buch Lopez”

Postal address:

Avenida 26 y Rancho Boyeros

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-78812413

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:

Cienfuegos, “Gustavo Aldereguia Lima” University Hospital, Dra. Martha Casanova Gonzalez; Specialist 2nd. Nephrology Degree

Pinar del Rio, San Cristobal, ''Comandante Pinares'' Hospital, Dr. Orosman Cuesta Panaco; First Degree Specialist in Nephrology

Research ethics committees:

National Institute of Nephrology (INEF), november 4, 2005.

“Gustavo Aldereguia Lima” University Hospital, november 15, 2005.

Comandante Pinares Hospital, september 4, 2006.

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

19/05/2006

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:

Non-terminal Chronic Kidney Disease, stage III.

Health condition(s) code:

Anemia

Renal Insufficiency, Chronic

Hematologic Diseases

Renal Insufficiency

Kidney Diseases

Urologic Diseases

Intervention(s):

Patients will be administered (Heberitro) recombinant EPO, dose: 30 UI/Kg of body weight, subcutaneously, three times a week, deltoid region, for one year treatment. If necessary, the dose will be maintained, increased or reduced every 4 weeks by 25% compared to previous dose to stabilization, depending on hemoglobin and/or hematocrit values.

Intervention code:

Epoetina alfa

Injections, Subcutaneous

Intervention keyword:

Recombinant Human Erythropoietin

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):

Hematocrit, measuring time: 1 year.

Key secondary outcomes:

Hemoglobin, measuring time: 1 year. Number of transfusions, measuring time: 1 year. Serum iron, measuring time: 1 year. Echocardiogram, measuring time: 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:

None

Inclusion criteria:

Glomerular Filtering Index (GFI): 59-30mL/min. Anemia under the following criteria: moderate anemia occurs with hemoglobin (Hb) concentration = 10.5 and 11.5 g/dL, and hematocrit (Ht) % = 30 and 33, in women and men, respectively. Patient’s consent in writing. Patients over 18 years of age.

Exclusion criteria:

Previous treatment on recombinant human erythropoietin. Patients on ERC under dialysis. Pregnancy, puerperium or breastfeeding. Septic syndrome. Iron deficiency (serum iron lower than 60 mcg/dL). Active oncological disease or patients on chemotherapy. Patients on hormonal preparations (except thyroid hormone, contraceptives, and insulin). Liver condition caused by TGP and TGO values doubling normal values. Uncontrolled high blood pressure (diastolic pressure equal to or higher than 90 and/or systolic pressure equal to or higher than 150 mmHg). Severe psychiatric disorder, mental retardation or any other condition preventing the patient from giving his/her consent. Folic acid or vitamin B12 deficiency (suspicious megaloblastic anemia by hematic biometry). Thrombocytosis (equal to or higher than 600,000/mm3). Active bleeding at any level. Aplastic anemia. Autoimmune disease. Hemoglobinopathies and membranopathies. Active collagen disease.

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:

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:

Idrian

Last Name:

Garcia Garcia

Specialty:

Degree in Pharmacy

Affiliation:

Clinical Trials Division, Center for Biological Research

Postal Address:

134 street, between 23 and 25 street. Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)- 2087379

Email :

idrian.garcia@cigb.edu.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:

Idrian

Last Name:

Garcia Garcia

Specialty:

Degree in Pharmacy

Affiliation:

Clinical Trials Division, Center for Biological Research

Postal Address:

134 street, between 23 and 25 street. Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)- 2087379

Email :

idrian.garcia@cigb.edu.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:

RPCEC00000041

Date of Registration in Primary Registry:

2010-12-20

Record Verification Date:

2008-02-12 19:00

Link to the spanish version:

Click here [3]