Effect of rEPO in FGF23 in ESRD Patients
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| ClinicalTrials.gov Identifier: NCT03803514 |
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Recruitment Status :
Completed
First Posted : January 14, 2019
Last Update Posted : May 27, 2020
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Anemia Chronic Kidney Diseases | Drug: Recombinant EPO |
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 |
| 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 : | August 15, 2017 |
| Actual Primary Completion Date : | March 31, 2019 |
| Actual Study Completion Date : | October 20, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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 Name: rEPO |
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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. |
- Changes in plasma intact FGF23 levels [ Time Frame: 12 weeks ]Measurements of plasma intact FGF23 levels
- 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
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803514
| Chile | |
| Hospital Clinico Universidad de Chile | |
| Santiago, Chile | |
| Study Chair: | Luis Michea, MD PhD | University of Chile |
| Responsible Party: | Luis Toro, Co-researcher, University of Chile |
| ClinicalTrials.gov Identifier: | NCT03803514 |
| Other Study ID Numbers: |
ID-11102-23 |
| First Posted: | January 14, 2019 Key Record Dates |
| Last Update Posted: | May 27, 2020 |
| Last Verified: | May 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases |
Renal Insufficiency Epoetin Alfa Hematinics |