EPANEM-III

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000041

Enrollment

Registered

2010-12-20

Start date

2006-05-19

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-terminal Chronic Kidney Disease, stage III.

Interventions

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 mai

Epoetina alfa

Injections, Subcutaneous

Recombinant Human Erythropoietin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Hematocrit, measuring time: 1 year.	—

Secondary

Measure	Time frame
Hemoglobin, measuring time: 1 year. Number of transfusions, measuring time: 1 year. Serum iron, measuring time: 1 year. Echocardiogram, measuring time: 1 year.	—

Countries

Cuba

Contacts

Public ContactIdrian Garcia Garcia

Clinical Trials Division, Center for Biological Research

idrian.garcia@cigb.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026