Hospital Clinico Universidad de Chile
Santiago, Chile
NCT Number: NCT03803514
Objective: To evaluate the effects of recombinant Erythropoietin (rEPO) in plasma levels of Fibroblast Growth Factor 23 (FGF23) in End-Stage Renal Disease (ESRD) patients in hemodialysis.
Method: Prospective cohort of ESRD patients in HD, where patients with or without rEPO therapy were compared. Measurements of plasma FGF23 were performed at baseline and during the complete study. Demographic, clinical and laboratory data will be obtained.
Follow-up period: 12 weeks.
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Notify Me18 year and older
All sexes
Observational
Santiago, Chile
Experimental data has shown that recombinant erythropoietin (rEPO) increases plasma levels of Fibroblast Growth Factor 23 (FGF23) in murines, both health and with acute or chronic renal disease. Also, observational studies indicate an association between EPO and FGF23 levels in patients. Until now, it has not been demonstrated whether the use of rEPO does increase plasma FGF23 in End-Stage Renal Disease (ESRD) patients in hemodialysis (a population with a high use of this therapy for the management of chronic anemia).
Our objective was to evaluate whether the administration of rEPO increases plasma FGF23 levels in ESRD patients in hemodialysis.
We performed a prospective cohort with ESRD patients without rEPO therapy. We performed 2 groups: patients with requirements of rEPO therapy due to anemia (Hb < 10 g/dL) and patients without rEPO therapy (Hb > 10 g/dL).
We measured plasma FGF23 (intact and C-terminal) at baseline and during 12 weeks.
Demographic, clinical and laboratory data was obtained. Patients treated with rEPO received beta-epoetin (Recormon, Roche), according to current recommendations.
Patients were follow-up during 3 months to evaluate the effects of rEPO. Our primary outcome was changes in plasma intact FGF23 at 12 weeks, between both groups.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Beta-epoetin (Recormon, Roche). Dosage was performed according to current recommendations.
Other names: rEPO
Time frame: 12 weeks
Measurements of plasma intact FGF23 levels
Time frame: 12 weeks
Measurements of plasma C-terminal FGF23 levels
Time frame: 12 weeks
Measurements of hematocrit and hemoglobin in blood samples
Time frame: 12 weeks
Measurements of parathormone levels in blood samples
University of Chile
Other
Effect of Recombinant Erythropoietin in Plasma Levels of FGF23 in End-Stage Renal Disease Patients
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