Trials / Completed
CompletedNCT03740048
A Pilot Trial of Twice-weekly Versus Thrice-weekly Hemodialysis in Patients With Incident End-stage Kidney Disease
A Randomized Pilot Study of Hemodialysis Initiation Comparing Twice-Weekly Hemodialysis Plus Dialysis-Sparing Therapy Versus Thrice-Weekly Hemodialysis (The TWOPLUS-HD Trial)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Hemodialysis | Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms. |
| DRUG | Patiromer Oral Product | Participants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer. |
Timeline
- Start date
- 2019-06-19
- Primary completion
- 2021-11-04
- Completion
- 2021-11-04
- First posted
- 2018-11-14
- Last updated
- 2023-06-09
- Results posted
- 2023-06-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03740048. Inclusion in this directory is not an endorsement.