Clinical trial NCT03740048: A Pilot Trial of Twice-weekly Versus Thrice-weekly Hemodialysis in Patients With Incident End-stage Kidney Disease
Official title: A Randomized Pilot Study of Hemodialysis Initiation Comparing Twice-Weekly Hemodialysis Plus Dialysis-Sparing Therapy Versus Thrice-Weekly Hemodialysis (The TWOPLUS-HD Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: End Stage Renal Failure on Dialysis
Keywords: Hemodialysis
Kidney Disease
Kidney Function
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

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.

Primary outcomes:
measure: Patients' Adherence to Study Protocol
timeFrame: 6 months, 12 months, 24 months
Secondary outcomes:
measure: 24-hour Urine Volume
timeFrame: Baseline, 6 Weeks, 12 Weeks, 24 Weeks
measure: Change in Residual Kidney Function - Urea Clearance
timeFrame: Baseline, 6 Weeks, 12 Weeks, 24 Weeks
measure: Change in Residual Kidney Function - Creatinine Clearance
timeFrame: Baseline, 6 Weeks, 12 Weeks, 24 Weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mariana Murea, MD
role: PRINCIPAL_INVESTIGATOR
References:
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