Anemia Clinical Trial
Official title:
Effect of Recombinant Erythropoietin in Plasma Levels of FGF23 in End-Stage Renal Disease Patients
Verified date | May 2020 |
Source | University of Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 20, 2019 |
Est. primary completion date | March 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Chile | Hospital Clinico Universidad de Chile | Santiago |
Lead Sponsor | Collaborator |
---|---|
University of Chile |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in plasma intact FGF23 levels | Measurements of plasma intact FGF23 levels | 12 weeks | |
Secondary | Changes in plasma C-terminal FGF23 levels | Measurements of plasma C-terminal FGF23 levels | 12 weeks | |
Secondary | Changes in hematocrit and hemoglobin | Measurements of hematocrit and hemoglobin in blood samples | 12 weeks | |
Secondary | Changes in parathormone levels | Measurements of parathormone levels in blood samples | 12 weeks |
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