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



Status:Not yet recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:11/16/2018
Start Date:April 2019
End Date:June 2021
Contact:Carrie Smith
Email:suscmit@wakehealth.edu
Phone:3367137531

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A Randomized Pilot Study of Hemodialysis Initiation Comparing Twice-Weekly Hemodialysis Plus Dialysis-Sparing Therapy Versus Thrice-Weekly Hemodialysis (The TWOPLUS-HD Trial)

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.


Inclusion Criteria:

- Age ≥18 years

- Have incremental CKD (including a failing renal transplant) to ESKD

- Are deemed to require dialysis initiation by the treating nephrologist

- Have elected HD for renal replacement therapy (RRT)

- Have eGFR ≥6.0ml/min/1.73m2 by four-variable Modification of Diet in Renal Disease
(MDRD) equation

- Can have HD initiated on a non-urgent basis

Exclusion Criteria:

- Age <18 years

- Have eGFR <6.0 ml/min/1.73m2 at the time of dialysis initiation, as reported in
electronic medical records, based on Modification of Diet in Renal Disease (MDRD)
equation

- Have anuria

- 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)

- Require urgent initiation of HD (within 24 hours of assessment)

- Were previously on other types of RRT

- 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.
We found this trial at
1
site
Winston-Salem, North Carolina 27157
Phone: 336-713-7531
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from
Winston-Salem, NC
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