Clinical trial NCT03803514: Effect of rEPO in FGF23 in ESRD Patients
Official title: Effect of Recombinant Erythropoietin in Plasma Levels of FGF23 in End-Stage Renal Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Chronic Kidney Diseases
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pacients in chronic hemodialysis, will be measured with FGF23 levels

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in plasma intact FGF23 levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in plasma C-terminal FGF23 levels
timeFrame: 12 weeks
measure: Changes in hematocrit and hemoglobin
timeFrame: 12 weeks
measure: Changes in parathormone levels
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Chile
Study officials:
affiliation: University of Chile
name: Luis Michea, MD PhD
role: STUDY_CHAIR
References: