EPANEM-III

Phase 4

• Conditions: on-terminal Chronic Kidney Disease, stage III.; Anemia; Renal Insufficiency, Chronic; Hematologic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases

• Registration Number: RPCEC00000041
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified