NCT03803514

Effect of rEPO in FGF23 in ESRD Patients

Effect of Recombinant Erythropoietin in Plasma Levels of FGF23 in End-Stage Renal Disease Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: University of Chile · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anemia
• Chronic Kidney Diseases

Interventions

Type	Name	Description
DRUG	Recombinant EPO	Beta-epoetin (Recormon, Roche). Dosage was performed according to current recommendations.

Timeline

• Start date: 2017-08-15
• Primary completion: 2019-03-31
• Completion: 2019-10-20
• First posted: 2019-01-14
• Last updated: 2020-05-27

Locations

1 site across 1 country: Chile