Effect of rEPO in FGF23 in ESRD Patients

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Anemia
• Intervention / Treatment: Drug: Recombinant EPO

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Hospital Clinico Universidad de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pacients in chronic hemodialysis, will be measured with FGF23 levels

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treated group (rEPO); Patients with ESRD in HD, and medical indication of recombinant EPO for management of anemia (Hb < 10 g/dL). Ambulatory hemodialysis 3 times per week. Recombinant beta-epoetin (Recormon) will be used, according to current recommendations. Clinical and laboratory data will be obtained before and during the study. The primary outcome (changes of plasma intact FGF23) will be measured during the follow-up, up to 12 weeks.	Drug: Recombinant EPO; Beta-epoetin (Recormon, Roche). Dosage was performed according to current recommendations.; Other Names: rEPO
Control group; Patients with ESRD and HD, without medical indication of recombinant EPO (Hb > 10 g/dL). Ambulatory hemodialysis 3 times per week. Follow-up for 3 months, similar than rEPO group. Clinical and laboratory data will be obtained before and during the study, similar periods than rEPO group. The primary outcome (changes of plasma FGF23) will be measured every 2 week during the evaluation period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in plasma intact FGF23 levels	Measurements of plasma intact FGF23 levels	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in plasma C-terminal FGF23 levels	Measurements of plasma C-terminal FGF23 levels	12 weeks
Changes in hematocrit and hemoglobin	Measurements of hematocrit and hemoglobin in blood samples	12 weeks
Changes in parathormone levels	Measurements of parathormone levels in blood samples	12 weeks

Collaborators and Investigators

• Sponsor: University of Chile
• Investigators: Study Chair: Luis Michea, MD PhD, University of Chile

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2017
• Primary Completion (ACTUAL): March 31, 2019
• Study Completion (ACTUAL): October 20, 2019

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (ACTUAL): January 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 25, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: ID-11102-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No