FGF23 and Cardiovascular Damage in Anemia With an Without Chronic Kidney Disease.

Launched by MAIMÓNIDES BIOMEDICAL RESEARCH INSTITUTE OF CÓRDOBA · Apr 27, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating how a substance called Fibroblast Growth Factor 23 (FGF23) relates to heart health in people with anemia, especially those with chronic kidney disease (CKD). Anemia can happen when the body does not have enough iron, which is common in CKD. The study aims to understand how higher levels of FGF23 might affect the heart and to explore different treatments for anemia, including various forms of intravenous (I.V.) iron. Researchers will look at blood samples and conduct experiments to see how these treatments impact FGF23 levels and heart health.

To participate in this trial, individuals should be between the ages of 65 and 74 and have low hemoglobin levels (less than 11 g/dl) and low iron storage (serum ferritin less than 100 ng/ml or low transferrin saturation). However, certain conditions, like recent major bleeding, active infections, or specific chronic diseases, may exclude someone from joining. Participants will undergo various tests, and their health will be monitored throughout the study to help researchers learn more about the connection between anemia, FGF23, and heart health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Hemoglobin \< 11g/dl
• • Serum ferritin \< 100 ng/ml or transferrin saturation index \< 20%
• Exclusion Criteria:
• • Weight \< 50 Kg or BMI \< 17
• • Acute bleeding \> 500 ml, within 72 hours before study inclusion
• • Proliferative hematologic disease. Hemochromatosis
• • Active infections within 30 days before study inclusion
• • Systemic inflammatory illness
• • Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis B virus (HBV) infection
• • Iron active treatment
• • Blood transfusion in the last 90 days before inclusion.
• • Cardiovascular hospitalization 30 days before study inclusion
• • Anticoagulant treatment with coumarins
• • Chronic liver disease
• • Immunosuppressive therapy
• • Erythropoiesis stimulating agents treatment, radiotherapy or chemiotherapy within 30 days before inclusion
• • Scheduled major surgery during study period
• • Pregnancy or lactation
• • Drugs addiction
• • Participation in others clinical trials.