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Effect of rEPO in FGF23 in ESRD Patients

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ClinicalTrials.gov Identifier: NCT03803514
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Luis Toro, University of Chile

Tracking Information
First Submitted Date January 10, 2019
First Posted Date January 14, 2019
Last Update Posted Date May 27, 2020
Actual Study Start Date August 15, 2017
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 25, 2020)
Changes in plasma intact FGF23 levels [ Time Frame: 12 weeks ]
Measurements of plasma intact FGF23 levels
Original Primary Outcome Measures
 (submitted: January 10, 2019)
Changes in plasma FGF23 levels [ Time Frame: Every 2 weeks, for 3 months ]
Measurements of plasma intact and C-terminal FGF23 levels
Change History
Current Secondary Outcome Measures
 (submitted: May 25, 2020)
  • Changes in plasma C-terminal FGF23 levels [ Time Frame: 12 weeks ]
    Measurements of plasma C-terminal FGF23 levels
  • Changes in hematocrit and hemoglobin [ Time Frame: 12 weeks ]
    Measurements of hematocrit and hemoglobin in blood samples
  • Changes in parathormone levels [ Time Frame: 12 weeks ]
    Measurements of parathormone levels in blood samples
Original Secondary Outcome Measures
 (submitted: January 10, 2019)
  • Changes in hematocrit and hemoglobin [ Time Frame: Every 2 weeks, for 3 months ]
    Measurements of hematocrit and hemoglobin in blood samples
  • Changes in parathormone levels [ Time Frame: Every 4 weeks, for 3 months ]
    Measurements of parathormone levels in blood samples
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of rEPO in FGF23 in ESRD Patients
Official Title Effect of Recombinant Erythropoietin in Plasma Levels of FGF23 in End-Stage Renal Disease Patients
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma samples
Sampling Method Non-Probability Sample
Study Population Pacients in chronic hemodialysis, will be measured with FGF23 levels
Condition
  • Anemia
  • Chronic Kidney Diseases
Intervention Drug: Recombinant EPO
Beta-epoetin (Recormon, Roche). Dosage was performed according to current recommendations.
Other Name: rEPO
Study Groups/Cohorts
  • 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.

    Intervention: Drug: Recombinant EPO
  • 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.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 25, 2020)
60
Original Estimated Enrollment
 (submitted: January 10, 2019)
40
Actual Study Completion Date October 20, 2019
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Chile
Removed Location Countries  
 
Administrative Information
NCT Number NCT03803514
Other Study ID Numbers ID-11102-23
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Luis Toro, University of Chile
Study Sponsor University of Chile
Collaborators Not Provided
Investigators
Study Chair: Luis Michea, MD PhD University of Chile
PRS Account University of Chile
Verification Date May 2020