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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03803514
Enrollment
60
Registered
2019-01-14
Start date
2017-08-15
Completion date
2019-10-20
Last updated
2020-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Chronic Kidney Diseases

Brief 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.

Interventions

DRUGRecombinant EPO

Beta-epoetin (Recormon, Roche). Dosage was performed according to current recommendations.

Sponsors

University of Chile
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* End-Stage Renal Disease * Requirements of Hemodialysis * At least 6 months since initiation of hemodialysis

Exclusion criteria

* Pregnancy * Treatment with rhEPO or analogs during the previous 6 months or earlier

Design outcomes

Primary

MeasureTime frameDescription
Changes in plasma intact FGF23 levels12 weeksMeasurements of plasma intact FGF23 levels

Secondary

MeasureTime frameDescription
Changes in plasma C-terminal FGF23 levels12 weeksMeasurements of plasma C-terminal FGF23 levels
Changes in hematocrit and hemoglobin12 weeksMeasurements of hematocrit and hemoglobin in blood samples
Changes in parathormone levels12 weeksMeasurements of parathormone levels in blood samples

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026