A Pilot Trial of Twice-weekly Versus Thrice-weekly Hemodialysis in Patients With Incident End-stage Kidney Disease
Status: | Not yet recruiting |
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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 |
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.
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.
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