Dry Weight Reduction Intervention Via Extra Ultrafiltration

NCT07637110 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY00025083R01DK141693
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fluid Accumulation; End Stage Renal Disease (ESRD); Blood Pressure Management

Keywords

ESRD; Volume overload; Fluid accumulation; End stage renal disease; Congestion; Chronic dialysis; Blood Pressure (High); Blood pressure management

Outcome Measures

Primary Outcomes (2)

• 24-hour continuous ambulatory blood pressure

  Blood pressure measured continously for a 24-hour period by wearing a blood pressure cuff on the upper arm.

  Measurement performed at baseline compared to measurement performed at 24 weeks.

• Symptoms of congestion.

  Change in sypmtoms of congestion caused by fluid overload which we will access by using the Kidney-modified Kansas City Cardiomyopathy Questionnaire.

  Questionnaire taken at Baseline compared the the questionnaire taken at 24 weeks.

Study Arms (3)

Ultrafiltration sessions for 4 weeks

ACTIVE COMPARATOR

Two ultrafiltration sessions per week plus pharmacist guided tapering of blood pressure medications in addition to the regular thrice weekly hemodialysis treatments.

Procedure: Ultrafiltration

Ultrafiltration sessions for 8 weeks

ACTIVE COMPARATOR

Two ultrafiltration sessions per week plus pharmacist guided tapering of blood pressure medications in addition to the regular thrice weekly hemodialysis treatments.

Procedure: Ultrafiltration

Control arm, no ultrafiltration sessions

NO INTERVENTION

Participant receives only their regularly scheduled thrice weekly hemodialysis treatments.

Interventions

Ultrafiltration PROCEDURE

Ultrafiltration for 4 or 8 weeks compared to no ultrafiltration.

Ultrafiltration sessions for 4 weeks; Ultrafiltration sessions for 8 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving thrice weekly in-center hemodialysis treatments for end stage kidney disease for at least four weeks and clinical suspicion of volume excess based on either:
• Persistent hypertension defined by three consecutive pre-dialysis systolic blood pressures ≥140 mmHg or three consecutive pre-dialysis systolic blood pressures 130-140 mmHg plus use of at least two anti-hypertensive medications that can be tapered.
• Symptoms of congestion defined by a 12-item Kidney Modified Kansas City Cardiomyopathy Questionnaire (KM-KCCQ) score \<75.

You may not qualify if:

• Age \<18 years
• Receiving hemodialysis treatments for acute kidney injury
• Receiving hemodialysis treatments for less than four weeks
• Planned switch to peritoneal or home dialysis within next three months
• Current or planned incremental hemodialysis (less than 3 treatments per week)
• Current or planned intensive hemodialysis (four or more treatments per week)
• Scheduled kidney transplantation
• Major cardiovascular or bleeding event within previous 90 days
• Receiving chemotherapy or radiation treatment for cancer
• History of cirrhosis with ascites
• Inability to complete 24-hour ambulatory blood pressure measurement
• Wheelchair dependance or other inability to complete six-minute walk test
• Pre-dialysis systolic blood pressure \<100 mmHg
• Scheduled use of midodrine with hemodialysis treatments
• History of non-adherence with dialysis treatments

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Northwest Kidney Centers

Seattle, Washington, 98112, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Edema; Hypertension

Interventions

Ultrafiltration

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Extracorporeal Circulation; Surgical Procedures, Operative; Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Physical Phenomena; Chemical Phenomena

Study Officials

• Bryan Kestenbaum, MD, MS

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luisa Rios-Avila

CONTACT

206-258-9325; lrios1@uw.edu

Ernest Ayers, MSPH

CONTACT

206-685-1423; ayerse@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medicine - Nephrology

Model Details: This is a randomized trial to test the effects of two concentrated ultrafiltration strategies in patients receiving maintenance hemodialysis treatments. We will determine the impact of the ultrafiltration strategies on blood pressure, congestion symptoms, and other key metrics of efficacy and safety

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: We will share the study protocol, informed consent form, and statistical analysis plan at the beginning of the study and indefinitely. We will share the analytic code when it becomes available.

Locations

US (1)