Anemia Clinical Trial
Official title:
Effect of Recombinant Erythropoietin in Plasma Levels of FGF23 in End-Stage Renal Disease Patients
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.
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.
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