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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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RPCEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RPCEC00000041 |
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Date of registration:
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20/12/2010 |
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Primary sponsor: |
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Public title:
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EPANEM-III
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Scientific title:
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Anemia treatment with Recombinant Human Erythropoietin in patients with Chronic Kidney Disease, pre-dialysis phase. |
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Date of first enrolment:
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19/05/2006 |
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Target sample size:
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20 |
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Recruitment status: |
Pending |
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URL:
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http://registroclinico.sld.cu/trials/RPCEC00000041-En |
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Study type:
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Interventional |
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Study design:
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Randomization: Nonrandomized Trial Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment
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Countries of recruitment
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Cuba
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Contacts
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Name:
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Idrian
Garcia Garcia |
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Address:
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134 street, between 23 and 25 street. Cubanacan, Playa
6162
Havana city
Cuba |
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Telephone:
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(53-7)- 2087379 |
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Email:
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idrian.garcia@cigb.edu.cu |
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Affiliation:
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Clinical Trials Division, Center for Biological Research |
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Name:
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Idrian
Garcia Garcia |
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Address:
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134 street, between 23 and 25 street. Cubanacan, Playa
6162
Havana City
Cuba |
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Telephone:
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(53-7)- 2087379 |
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Email:
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idrian.garcia@cigb.edu.cu |
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Affiliation:
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Clinical Trials Division, Center for Biological Research |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 years
Age maximum:
None
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-terminal Chronic Kidney Disease, stage III.
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Intervention(s)
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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.
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Primary Outcome(s)
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Hematocrit, measuring time: 1 year.
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Secondary Outcome(s)
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Hemoglobin, measuring time: 1 year. Number of transfusions, measuring time: 1 year. Serum iron, measuring time: 1 year. Echocardiogram, measuring time: 1 year.
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Secondary ID(s)
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IG/EPI/CP/0405
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Source(s) of Monetary Support
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Ministry of Public Health, CUBA
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