Effect of rEPO in FGF23 in ESRD Patients

NCT ID: NCT03803514

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-15
• Study Completion Date: 2019-10-20

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.

Conditions

Anemia; Chronic Kidney Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Recombinant EPO

Intervention Type: DRUG

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

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.

No interventions assigned to this group

Interventions

Recombinant EPO

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

Intervention Type: DRUG

Other Intervention Names

rEPO

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Luis Toro

Co-researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luis Michea, MD PhD

Role: STUDY_CHAIR

University of Chile

Locations

Hospital Clinico Universidad de Chile

Santiago, , Chile

Countries

Chile

Other Identifiers

ID-11102-23

Identifier Type: -

Identifier Source: org_study_id