Determination of FDF-23 Levels in Non-suppressible PTH Secretion and the Influence of Inflammation on Fetuin A Levels During Hemodialysis Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- change in serum fibroblast growth factor-23 (FGF-23)
研究概览
简要总结
The purpose of this study is to determine how levels of this newly-discovered hormone, called FGF-23, changes in the blood in response to a high calcium dialysis bath during a hemodialysis (HD) treatment, and how this relates to changes in the calcium and PTH levels. We are also studying the effects of dialysis and inflammation on the levels of Fetuin A.
We intend to prospectively study a cohort of end stage renal disease (ESRD) patients on hemodialysis in order to determine whether FDF-23 levels independently affect non-suppressible PTH levels. The relationship between Fetuin A and inflammatory markers will also be determined. By dialyzing patients on 3.5 mEq/L calcium dialysate bath, we seek any relationship between ionized calcium, FGF-23 and PTH.
详细描述
The goal of this study is to ascertain whether there is a regulatory relationship between the novel phosphorus-regulating polypeptide fibroblast growth factor-23 (FGF-23), ionized calcium (iCa), and parathyroid hormone (PTH) levels. In addition, we will determine if there is an inverse relationship between Fetuin A levels and inflammatory markers, interleukin 6 (IL-6) and C-reactive protein (CRP), during a hemodialysis treatment.
All patients participating in this study will be off Zemplar and/or Sensipar for a washout period of approximately 4 weeks as these medications will interfere with the study. Patients will go through one designated research hemodialysis time for a blood draw. Blood draws will be taken during 4 separate intervals at 0, 45, 90 and 150 minutes. At each interval, 4 tubes of blood will be drawn.
There are no further required blood draws once each designated research HD session has been completed. At the conclusion of the designated research HD session, vitamin D analogue (Zemplar®) and/or Cinacalcet (Sensipar®) will be restarted, and the dose will be adjusted to reflect the subject's recent biochemical markers (Ca, Phos, and iPTH).
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
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
- •18 years or older
- •Chronic Hemodialysis for more than 3 months
- •iPTH levels ≥ 300 pg/ml in the absence of therapy: Cinacalcet (Sensipar ®) and/or 1,25 Vitamin analogues (Zemplar®)
- •Corrected Ca ≥ 8.4 mg/dl at time of enrollment
- •Ability to stay at least 3 hours during hemodialysis treatment
排除标准
- •Pediatric Patients (age ≤ 18 years)
- •Those unable to give informed consent
- •Dialysis treatment for less than 3 months, or pre-emptive kidney transplantation
- •Inability to stay more than 3 hours during a single hemodialysis treatment period
结局指标
主要结局
change in serum fibroblast growth factor-23 (FGF-23)
时间窗: 0, 45, 90, and 150 minutes
次要结局
未报告次要终点
研究者
James B. Wetmore, MD
Associate Professor
University of Kansas Medical Center