Phase 3
Completed N=48
A Pilot Trial of Twice-weekly Versus Thrice-weekly Hemodialysis in Patients With Incident End-stage Kidney Disease
End Stage Renal Failure on Dialysis
Source: ClinicalTrials.gov NCT03740048 ↗
Enrolled (actual)
48
Serious AEs
52.3%
Results posted
Jun 2023
Primary outcomePrimary: Patients' Adherence to Study Protocol — 22; 24; 19; 19 Participants
◆ Published Evidence
Established
41citations · ~10 / year
Twice-Weekly Hemodialysis With Adjuvant Pharmacotherapy and Transition to Thrice-Weekly Hemodialysis: A Pilot Study.
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.
Linked Publications (4)
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Twice-Weekly Hemodialysis With Adjuvant Pharmacotherapy and Transition to Thrice-Weekly Hemodialysis: A Pilot Study.
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Precision medicine approach to dialysis including incremental and decremental dialysis regimens.
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Renal replacement treatment initiation with twice-weekly versus thrice-weekly haemodialysis in patients with incident dialysis-dependent kidney disease: rationale and design of the TWOPLUS pilot clinical trial.
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Patient-reported outcomes in a pilot clinical trial of twice-weekly hemodialysis start with adjuvant pharmacotherapy and transition to thrice-weekly hemodialysis vs conventional hemodialysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients' Adherence to Study Protocol |
22; 24; 19; 19; 10; 10 | — |
| SECONDARY 24-hour Urine Volume |
914; 1424; 504; 553; 479; 484 | — |
| SECONDARY Change in Residual Kidney Function - Urea Clearance |
3.3; 4.1; 2.3; 2.3; 2.1; 2.0 | — |
| SECONDARY Change in Residual Kidney Function - Creatinine Clearance |
8.4; 10.8; 5.5; 6.8; 5.3; 5.8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03740048) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.