Effect of rEPO in FGF23 in ESRD Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anemia, Chronic Kidney Diseases

Intervention / Treatment
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* Drug: Recombinant EPO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated group (rEPO)<br>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<br>* Beta-epoetin (Recormon, Roche). Dosage was performed according to current recommendations.<br>* Other names: rEPO;|
| Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasma intact FGF23 levels | Measurements of plasma intact FGF23 levels | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasma C-terminal FGF23 levels | Measurements of plasma C-terminal FGF23 levels | 12 weeks | 
| Changes in hematocrit and hemoglobin | Measurements of hematocrit and hemoglobin in blood samples | 12 weeks | 
| Changes in parathormone levels | Measurements of parathormone levels in blood samples | 12 weeks |