A Pilot Trial of Twice-weekly Versus Thrice-weekly Hemodialysis in Patients With Incident End-stage Kidney Disease

Phase 3

Completed

• Conditions: End Stage Renal Failure on Dialysis
• Interventions: Other: Hemodialysis; Drug: Patiromer Oral Product

• Registration Number: NCT03740048
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-09
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-14
• Study Start: 2019-06-19
• Primary Completion: 2021-11-04
• Study Completion: 2021-11-04
• Status Verified: 2022-04
• Results First Submitted: 2023-04-04
• Results First Submitted QC: 2023-06-01
• Results First Posted: 2023-06-05
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• 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)

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemodialysis and Pharmacologic Therapy	Patiromer Oral Product	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)
Conventional Hemodialysis Regimen	Hemodialysis	Hemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis
Hemodialysis and Pharmacologic Therapy	Hemodialysis	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)

Primary Outcome Measures

Name	Time	Method
Patients' Adherence to Study Protocol	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

Secondary Outcome Measures

Name	Time	Method
24-hour Urine Volume	Baseline, 6 Weeks, 12 Weeks, 24 Weeks	Residual renal clearance was calculated based on 24-hour urine collection performed at baseline at enrollment; and interdialytic urine collection performed at baseline, 6 Weeks, 12 Weeks and 24 Weeks
Change in Residual Kidney Function - Urea Clearance	Baseline, 6 Weeks, 12 Weeks, 24 Weeks	Residual renal clearance was calculated based on 24-hour urine collection performed at baseline at enrollment; and interdialytic urine collection performed during weeks 6, 12, and 24.
Change in Residual Kidney Function - Creatinine Clearance	Baseline, 6 Weeks, 12 Weeks, 24 Weeks	Residual renal clearance was calculated based on 24-hour urine collection performed at baseline at enrollment; and interdialytic urine collection performed during weeks 6, 12, and 24.

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States