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Incremental Hemodialysis Frequency for Kidney Failure

N/A
Recruiting
Led By Mariana Murea, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Has received ≤18 sessions of intermittent HD (i.e., on HD for ≤6 weeks) at the time patient is approached for potential study participation
Must not have
Unable or unwilling to follow the study protocol for any reason
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 2
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two types of dialysis treatments to find which works best for people with new kidney failure and some remaining kidney function.

Who is the study for?
Adults over 18 with new-onset kidney dysfunction requiring dialysis can join this trial. They should have started or be starting in-center hemodialysis soon, and not been on it for more than 6 weeks. Participants need some remaining kidney function and urine output. Those with certain blood chemistry imbalances, high fluid removal needs, a short life expectancy, or pregnancy are excluded.
What is being tested?
The TwoPlus Trial is comparing two schedules of hemodialysis for people with kidney failure: one group will receive treatments twice a week while the other will have them three times a week. The goal is to see which frequency is better when patients still have some kidney function left.
What are the potential side effects?
Hemodialysis side effects may include low blood pressure, muscle cramps, itching, sleep problems, anemia (low red blood cell count), bone diseases due to mineral imbalance and access site complications among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have had 18 or fewer dialysis sessions over 6 weeks or less.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to follow or unwilling to commit to the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and year 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Clinical events of safety
Secondary study objectives
Caregiver burden Zarit Caregiver Burden Scores Health-related quality of life Health-related quality of life and residual kidney function
Change in kidney creatinine clearance (mL/min/1.73 m2)
Change in kidney urea clearance (mL/min/1.73 m2)
+8 more
Other study objectives
Characterize implementation processes using mixed methods - Adoption
Characterize implementation processes using mixed methods - External factors that mediate implementation
Characterize implementation processes using mixed methods - Fidelity, to assess adherence to serial timed urine collection and HD treatment schedule
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Clinically-matched Incremental Hemodialysis ( CMIHD)Experimental Treatment1 Intervention
Randomized group to have hemodialysis prescription tailored based on residual kidney function and clinical manifestations starting at twice weekly.
Group II: Conventional Hemodialysis (CHD)Active Control1 Intervention
Randomized group to conventional three times a week hemodialysis.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,394 Previous Clinical Trials
2,459,686 Total Patients Enrolled
2 Trials studying Kidney Failure
5,030 Patients Enrolled for Kidney Failure
Patient-Centered Outcomes Research InstituteOTHER
574 Previous Clinical Trials
27,078,609 Total Patients Enrolled
Mariana Murea, MDPrincipal InvestigatorWake Forest Health Sciences
4 Previous Clinical Trials
198 Total Patients Enrolled

Media Library

Conventional Hemodialysis (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05828823 — N/A
Kidney Failure Research Study Groups: Conventional Hemodialysis (CHD), Clinically-matched Incremental Hemodialysis ( CMIHD)
Kidney Failure Clinical Trial 2023: Conventional Hemodialysis Highlights & Side Effects. Trial Name: NCT05828823 — N/A
Conventional Hemodialysis (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05828823 — N/A
~233 spots leftby Sep 2027
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