Investigating the link between FGF23 and cardiovascular damage in anemia and chronic kidney disease.
The Role of FGF23 on the Induction of Cardiovascular Damage in Anemia With an Without Chronic Kidney Disease
Maimónides Biomedical Research Institute of Córdoba · NCT05356325
This study is trying to see if high levels of a protein called FGF23 are linked to heart problems in people with anemia, whether or not they also have chronic kidney disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 401 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Maimónides Biomedical Research Institute of Córdoba (other) |
| Locations | 1 site (Córdoba) |
| Trial ID | NCT05356325 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the cardiovascular alterations associated with increased levels of fibroblast growth factor 23 (FGF23) in patients with anemia, both with and without chronic kidney disease (CKD). It will analyze serum samples from patients to determine the relationship between iron metabolism parameters, FGF23 levels, and markers of cardiovascular damage. The study will include individuals aged 18 and older with specific hemoglobin and serum ferritin levels, while excluding those with certain medical conditions or recent treatments that could affect the results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with anemia due to iron deficiency, either with normal renal function or stages 3 and 4 of CKD.
Not a fit: Patients with active malignancies, severe proteinuria, or those receiving certain treatments like anticoagulants or erythropoiesis-stimulating agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of cardiovascular risks in patients with anemia and CKD.
How similar studies have performed: While the relationship between FGF23 and cardiovascular risk is being explored, this specific approach in the context of anemia and CKD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Córdoba
- Hospital Universitario Reina Sofia — Córdoba, Spain (RECRUITING)
Study contacts
- Principal investigator: Juan Muñoz Castañeda, MD — Maimónides Biomedical Research Institute of Córdoba
- Study coordinator: Casimiro Valle Domínguez, MD
- Email: casimiro.valle.sspa@juntadeandalucia.es
- Phone: 34 957010000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibroblast Growth Factor 23, Anemia, CKD, FGF23, anemia, iron deficiency, cardiovascular risk, miRNAS