Ultrafiltration for Kidney Failure

(DRIVE-UF Trial)

LR
EA
Overseen ByErnest Ayers, MSPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Washington
Must be taking: Anti-hypertensives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Most patients who receive hemodialysis treatments have excess fluid in their body that has slowly built up over the course of kidney disease. This extra fluid is the main cause of high blood pressure in dialysis and leads to stress on the heart and lungs.that causes debilitating symptoms and frequent hospitalizations.

This trial will test whether a focused program of 4 or 8 weeks of extra ultrafiltration treatments can remove most of this extra fluid. We believe that getting rid of large amounts of extra fluid will result in sustained improvements in blood pressure and symptoms. Ultrafiltration is a gentler type of dialysis that removes fluid but does not clean the blood.

Who Is on the Research Team?

BK

Bryan Kestenbaum, MD, MS

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for people with kidney failure who are on hemodialysis and have problems with extra fluid in their body, such as swelling or high blood pressure. Participants should be able to safely undergo additional fluid removal sessions.

Inclusion Criteria

I have high blood pressure before dialysis, possibly due to extra fluid in my body.
I have symptoms of fluid buildup and a KM-KCCQ score below 75.
I have been getting in-center hemodialysis three times a week for at least four weeks.

Exclusion Criteria

I am currently on or planning to start intensive hemodialysis (4+ times per week).
I have not had a major heart or bleeding event in the last 90 days.
I am currently receiving chemotherapy or radiation for cancer.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a four-week or eight-week ultrafiltration strategy, or continue regular hemodialysis treatments

4-8 weeks
2 extra visits per week for ultrafiltration

Follow-up

Participants are monitored for changes in blood pressure and symptoms of congestion

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ultrafiltration

Trial Overview

The study tests whether doing extra ultrafiltration treatments over 4 or 8 weeks can remove more excess fluid than usual care, aiming to improve blood pressure and reduce symptoms related to too much fluid.

How Is the Trial Designed?

3

Treatment groups

Active Control

Group I: Ultrafiltration sessions for 4 weeksActive Control1 Intervention
Group II: Ultrafiltration sessions for 8 weeksActive Control1 Intervention
Group III: Control arm, no ultrafiltration sessionsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+