Effect of Recombinant Erythropoietin in Plasma Levels of FGF23 in End-Stage Renal Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in plasma intact FGF23 levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End-Stage Renal Disease
- •Requirements of Hemodialysis
- •At least 6 months since initiation of hemodialysis
排除标准
- •Pregnancy
- •Treatment with rhEPO or analogs during the previous 6 months or earlier
研究组 & 干预措施
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.
干预措施: Recombinant EPO (Drug)
结局指标
主要结局
Changes in plasma intact FGF23 levels
时间窗: 12 weeks
Measurements of plasma intact FGF23 levels
次要结局
- Changes in plasma C-terminal FGF23 levels(12 weeks)
- Changes in hematocrit and hemoglobin(12 weeks)
- Changes in parathormone levels(12 weeks)
研究者
Luis Toro
Co-researcher
University of Chile