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Completed

NCT Number: NCT03803514

Effect of rEPO in FGF23 in ESRD 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recombinant EPO

Drug

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

Other names: rEPO

Primary outcomes

  1. Changes in plasma intact FGF23 levels

    Time frame: 12 weeks

    Measurements of plasma intact FGF23 levels

Secondary outcomes

  1. Changes in plasma C-terminal FGF23 levels

    Time frame: 12 weeks

    Measurements of plasma C-terminal FGF23 levels

  2. Changes in hematocrit and hemoglobin

    Time frame: 12 weeks

    Measurements of hematocrit and hemoglobin in blood samples

  3. Changes in parathormone levels

    Time frame: 12 weeks

    Measurements of parathormone levels in blood samples

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 14, 2019
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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