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Effect of rEPO in FGF23 in ESRD Patients

Sponsor
University of Chile (Other)
Overall Status
Completed
CT.gov ID
NCT03803514
Collaborator
(none)
60
Enrollment
1
Location
26.2
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of Recombinant Erythropoietin in Plasma Levels of FGF23 in End-Stage Renal Disease Patients
Actual Study Start Date :
Aug 15, 2017
Actual Primary Completion Date :
Mar 31, 2019
Actual Study Completion Date :
Oct 20, 2019

Arms and Interventions

Arm 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.

    Outcome Measures

    Primary Outcome Measures

    1. Changes in plasma intact FGF23 levels [12 weeks]

      Measurements of plasma intact FGF23 levels

    Secondary Outcome Measures

    1. Changes in plasma C-terminal FGF23 levels [12 weeks]

      Measurements of plasma C-terminal FGF23 levels

    2. Changes in hematocrit and hemoglobin [12 weeks]

      Measurements of hematocrit and hemoglobin in blood samples

    3. Changes in parathormone levels [12 weeks]

      Measurements of parathormone levels in blood samples

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Clinico Universidad de Chile Santiago Chile

    Sponsors and Collaborators

    • University of Chile

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Luis Toro, Co-researcher, University of Chile
    ClinicalTrials.gov Identifier:
    NCT03803514
    Other Study ID Numbers:
    • ID-11102-23
    First Posted:
    Jan 14, 2019
    Last Update Posted:
    May 27, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic

    Study Results

    No Results Posted as of May 27, 2020