A Randomized Pilot Study of Hemodialysis Initiation Comparing Twice-Weekly Hemodialysis Plus Dialysis-Sparing Therapy Versus Thrice-Weekly Hemodialysis (The TWOPLUS-HD Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Patients' Adherence to Study Protocol
研究概览
简要总结
The optimal frequency of hemodialysis treatments in patients with incident end-stage kidney disease in not known. This pilot trial will randomize patients with incident end-stage kidney disease due to chronic kidney disease progression to two different regimens of hemodialysis: i) twice-weekly hemodialysis for six weeks with adjuvant pharmacologic medications followed by thrice-weekly hemodialysis, or ii) thrice-weekly hemodialysis. The study will test feasibility of stepwise hemodialysis, and the effects of the two regimens of hemodialysis on residual kidney function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Incident ESKD from CKD progression (including a failing renal transplant)
- •Are deemed to require dialysis initiation by the treating nephrologist
- •Have elected HD for renal replacement therapy (RRT)
排除标准
- •Have urine output <500ml per day
- •Have ESKD as a result of severe acute kidney injury (AKI) (stage 3 AKI defined by Acute Kidney Injury Network [AKIN]) criteria)
- •Abrupt decline in kidney function preceding HD therapy initiation (i.e., if eGFR was ≥30 mL/min/1.73 m2 3 months prior to the initiation of dialysis therapy)
- •Are scheduled to undergo transplantation from a live donor within the next 6 months
- •Have an active diagnosis of hepatorenal syndrome
- •Have a significant malignancy that is likely to impact survival
- •Have a medical condition that would jeopardize the safety of the subject.
研究组 & 干预措施
Hemodialysis and Pharmacologic Therapy
Hemodialysis regimen at the initiation of dialysis treatment: Twice-weekly hemodialysis plus adjunctive pharmacologic therapy (loop diuretic, potassium-binding agent, and sodium bicarbonate) for six consecutive weeks, continued by thrice-weekly hemodialysis (intervention group)
干预措施: Hemodialysis (Other)
Hemodialysis and Pharmacologic Therapy
Hemodialysis regimen at the initiation of dialysis treatment: Twice-weekly hemodialysis plus adjunctive pharmacologic therapy (loop diuretic, potassium-binding agent, and sodium bicarbonate) for six consecutive weeks, continued by thrice-weekly hemodialysis (intervention group)
干预措施: Patiromer Oral Product (Drug)
Conventional Hemodialysis Regimen
Hemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis
干预措施: Hemodialysis (Other)
结局指标
主要结局
Patients' Adherence to Study Protocol
时间窗: 6 months, 12 months, 24 months
≥95% of participants randomized in the intervention group will adhere to the HD regimen. All participants who completed 6 and 12 months of follow-up completed interdialytic timed urine collections - Patient adherence to the study protocol was assessed by the number of participants randomized to each intervention who adhered to the study protocol and at 6 months and at 12 months
次要结局
- 24-hour Urine Volume(Baseline, 6 Weeks, 12 Weeks, 24 Weeks)
- Change in Residual Kidney Function - Urea Clearance(Baseline, 6 Weeks, 12 Weeks, 24 Weeks)
- Change in Residual Kidney Function - Creatinine Clearance(Baseline, 6 Weeks, 12 Weeks, 24 Weeks)