Effect of rEPO in FGF23 in ESRD Patients

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03803514
• Other study ID #: ID-11102-23
• Status: Completed
• Start date: August 15, 2017
• Est. completion date: October 20, 2019

Study information

• Verified date: May 2020
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 20, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Recombinant EPO
Beta-epoetin (Recormon, Roche). Dosage was performed according to current recommendations.

Locations

Country	Name	City	State
Chile	Hospital Clinico Universidad de Chile	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in plasma intact FGF23 levels	Measurements of plasma intact FGF23 levels	12 weeks
Secondary	Changes in plasma C-terminal FGF23 levels	Measurements of plasma C-terminal FGF23 levels	12 weeks
Secondary	Changes in hematocrit and hemoglobin	Measurements of hematocrit and hemoglobin in blood samples	12 weeks
Secondary	Changes in parathormone levels	Measurements of parathormone levels in blood samples	12 weeks