Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients Treated With Hemodialysis (PEARL-HD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Total Number of Episodes of Serum Potassium ≥ 5.5 mEq/L
研究概览
简要总结
The purpose of this study is to determine whether once-daily dosing of patiromer will reduce the frequency of hyperkalemic episodes in ESRD (end stage renal disease) study participants who receive conventional hemodialysis (HD). The study objective is to determine if patiromer administered orally once a day with breakfast or lunch will reduce episodes of hyperkalemia in ESRD study participants who receive thrice-weekly HD.
详细描述
This is a prospective, randomized, open-label trial. Eligible ESRD patients who are on thrice weekly HD schedule will be screened from retrospective review of clinical and laboratory parameters from our clinical practice group. A total of 40 study participants (randomized 1:1 study drug: usual care) will be enrolled. Duration of study medication exposure will be 4 weeks. The total duration of study, from enrollment until the end of the washout period will be 7 weeks.
This is a proof of concept study, to determine whether administration of patiromer has the potential to change the risk category for ESRD patients who are on conventional HD schedules. In addition, the study will develop and pilot study procedures that could be implemented in a large-scale clinical trial. By nature of the limited size of the study, the power of the trial will be limited. Reducing serum potassium with the use of low dialysate potassium is actually associated with an increased risk of sudden cardiac death. Furthermore, HD patients already carry a high pill burden, and it is unclear if prescription of an additional oral medication will reduce the frequency of episodic hyperkalemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study is open-label and therefore the subjects, coordinators and investigators are not blinded to the intervention. Titration of the patiromer will require viewing of the serum potassium values. During the data analysis, however, personnel involved will remain blinded.
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
- •Males and Females, age at least 18 years
- •ESRD treated with thrice-weekly HD for ≥ 6 months.
- •At least two measured pre-dialysis serum [K] ≥ 5.5 mEq/L or one [K] ≥ 6.0 mEq/L noted over the past three months
- •Current use of dialysate with potassium concentration ≤ 2 mEq/L
- •Typical consumption of at least two meals per day
- •Have received customary dietary instruction over prior month
- •Considered by the treating physician(s) to be in otherwise stable clinical condition.
- •If patient is of childbearing potential, he/she will be willing to avoid pregnancy during the study using an acceptable birth control method.
排除标准
- •Not considered by the treating physician(s) to be adherent with recommended dialysis schedule and prescribed medications
- •Life expectancy < 3 months
- •Dialysis-dependent for less than 6 months
- •Non-elective hospitalization in prior 3 months
- •Currently prescription of oral potassium supplements
- •In the prior 3 months, therapy with oral potassium-lowering medication
- •Underlying severe gastrointestinal disorders, including history of ischemic bowel.
- •Corrected serum calcium concentration > 10.5 mg/dL in prior three months
- •Anticipated kidney transplant within the next 3 months
- •Prisoners or others who are involuntarily incarcerated or detained
- •Pregnant, breastfeeding, or considering pregnancy.
- •Participation in a clinical trial of an experimental treatment within the past 30 days
研究组 & 干预措施
Patiromer Oral Powder Product
Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K < 4.0 mEq/L, and patiromer will be discontinued if K < 3.5 mEq/L.
干预措施: Patiromer Oral Powder Product (Drug)
结局指标
主要结局
Total Number of Episodes of Serum Potassium ≥ 5.5 mEq/L
时间窗: Week 4
To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis.
次要结局
- Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline(Baseline)
- Number of Episodes of Serum Potassium ≥ 5.5 mEq/L Per Participant(4 weeks)
- Median Daily Dose of Patiromer That Was Given in Treatment Arm(Week 3)
- Number of Additional Hemodialysis Treatments Due to Hyperkalemia(4 weeks)
- Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Week 4(Week 4)
- Number of Participants Who Completed All Study Visits(4 weeks)
- Number of Participants With More Than 1000 Premature Ventricular Contractions (PVCs) in 24 Hours(4 weeks)
- Change in Serum Albumin Concentration(4 weeks)
- Change in Parathyroid Hormone (PTH) Concentration(4 weeks)
- Change in Serum Potassium Concentration Two Weeks After Study Drug is Discontinued(6 weeks)
- Change in Serum Phosphorus Concentration Two Weeks After Study Drug Has Been Discontinued(6 weeks)