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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 2

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 2

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Clinical events of safety

Secondary outcome measures

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 outcome measures

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

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,243 Previous Clinical Trials

1,004,376 Total Patients Enrolled

2 Trials studying Kidney Failure

5,030 Patients Enrolled for Kidney Failure

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,997,108 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research centers are currently conducting this experiment?

"The trial is being conducted at a multitude of locations, including Harbor University of California Los Angeles in Torrance, Indiana University (IU) in Indianapolis and Johns Hopkins University School of Medicine (JHUSM) located in Baltimore. An additional nine sites are participating as well."

Answered by AI

Are there any opportunities for individuals to become participants in this experiment?

"According to clinicaltrials.gov, this particular medical trial is not in the process of recruiting patients at present. It was initially posted on September 1st 2023 and last updated April 25th 2023. Though it's not actively seeking participants, there are an abundance of other trials that currently require volunteers; 625 precisely."

Answered by AI