The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of End Stage Renal Disease Patients With Hyperkalemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Adverse Events of Participants Taking Patiromer in Lowering Serum Potassium Levels in End Stage Renal Disease (ESRD) Patients With Hyperkalemia Measured by Gastrointestinal Symptom Rating Scale (GSRS)
研究概览
简要总结
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia (potassium greater than 5 milliequivalents per liter) is a non-randomized, crossover study. This is an open-label, pilot clinical trial with 3 sequential phases of (a) 2 weeks of no intervention, (b) 12 weeks of Patiromer treatment, and (c) 6 weeks of no intervention. Treatment with Patiromer will be initiated at a dose of 8.4 grams, once daily and observed for a week, then uptitrated to 16.8 grams once daily. Eligible study subjects will collect stool samples and provide blood and urine samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects on stable hemodialysis for more than 90 days.
- •Age 18-85 years.
- •Persistent hyperkalemia, defined as elevated serum potassium > 5.0 mEq/L in more than 2 occasions during the previous 3 months.
排除标准
- •Use of pre- or probiotics during the past 2 months
- •Use of antibiotics within the past 2 months, if the patient received a single course of antibiotic.
- •Presence of chronic wound infection and osteomyelitis
- •Inflammatory bowel disease, chronic diarrhea, current C. difficile infection
- •Liver cirrhosis or chronic active hepatitis
- •Treatment with immunosuppressive medications in the past 6 months or more than a week of treatment with prednisone > 10 mg in the last 3 months
- •Anticipated kidney transplant within 9 months
- •Expected survival < 9 months
- •Pregnancy, anticipated pregnancy, or breastfeeding
- •Incarceration
- •Participation in another intervention study
- •severe anemia defined as hemoglobin < 8.0 g/dl any time during the last 2 months
研究组 & 干预措施
Patiromer
This arm is a 2 week observation period before the start of the Patiromer treatment phase, followed by a 12 week treatment phase, and 6 week no treatment observation phase.
Pre-Treatment (Wk 1-2): Observational period. Baseline sample collection of blood and stool. No medication.
Treatment (Wk 3-14): Participants will take 8.4 grams of Patiromer once daily for one week, during which serum potassium and gastrointestinal symptoms will be evaluated. If tolerated and in the absence of hypokalemia, the dose will be up-titrated to 16.8 grams once daily for the remaining 11 weeks. Blood and stool will be collected.
Post-Treatment (Wk 15-20): Observational period. No medication. Blood and stool will be collected.
干预措施: Patiromer (Drug)
结局指标
主要结局
Adverse Events of Participants Taking Patiromer in Lowering Serum Potassium Levels in End Stage Renal Disease (ESRD) Patients With Hyperkalemia Measured by Gastrointestinal Symptom Rating Scale (GSRS)
时间窗: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
The Gastrointestinal Symptom Rating Scale was used to measures any potential side effects due to study medication. Survey was administered at Wk 1, Wk 8, Wk 14, and Wk 20. For symptoms (abdomen pain - diarrhea) a score of 0 indicates "no discomfort", 1 = "mild discomfort", 2=moderate, 3=severe; higher score means a worse outcome For stool form, 1=Well formed, 2=Semi formed, 3= Loose, 4= Liquid;higher score means a worse outcome For number of stools per day, 1= \<1, 2=1 or 2, 3=3 or 4, 4=5 or 6,5= 7 or more; higher score means a worse outcome
Serum Potassium Level Through 12 Weeks of Treatment
时间窗: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Blood was collected during Pre-Treatment week 2, Treatment Week 14, and Post-Treatment week 20
Changes in Blood Chemistry During the Study
时间窗: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Stool Electrolytes During the Study Phases
时间窗: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
次要结局
- Changes in Gut Microbiome of Hyperkalemic ESRD Patients Treated With Patiromer.(Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-treatment))
- Changes in Plasma Metabolites Using p-Cresol of Hyperkalemic ESRD Patients Treated With Patiromer(Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment))
研究者
Dominic Raj
Director of the Division of Renal Disease and Hypertension, Professor of Medicine
George Washington University