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Hemodialysis for Kidney Disease (TWOPLUS-HD Trial)

Phase 3

Waitlist Available

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months, 12 months, 24 months

Awards & highlights

TWOPLUS-HD Trial Summary

This trial will test the feasibility of different regimens of hemodialysis, and the effects of those regimens on residual kidney function.

Eligible Conditions

End Stage Kidney Disease on Dialysis

TWOPLUS-HD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months, 12 months, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months, 12 months, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 12 months, 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Patients' Adherence to Study Protocol

Secondary outcome measures

24-hour Urine Volume

Change in Residual Kidney Function - Creatinine Clearance

Change in Residual Kidney Function - Urea Clearance

Other outcome measures

Long-term change in residual kidney function

Survival

Side effects data

From 2021 Phase 3 trial • 51 Patients • NCT03740048

41%

hospitalization

Hospitalization

100%

80%

60%

40%

20%

Study treatment Arm

Conventional Hemodialysis Regimen

Hemodialysis and Pharmacologic Therapy

TWOPLUS-HD Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Hemodialysis and Pharmacologic TherapyExperimental Treatment2 Interventions

Hemodialysis regimen at the initiation of dialysis treatment: Twice-weekly hemodialysis plus adjunctive pharmacologic therapy (loop diuretic, potassium-binding agent, and sodium bicarbonate) for six consecutive weeks, continued by thrice-weekly hemodialysis (intervention group)

Group II: Conventional Hemodialysis RegimenActive Control1 Intervention

Hemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Patiromer Oral Product

2019

Completed Phase 4

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,241 Previous Clinical Trials

1,004,186 Total Patients Enrolled

Mariana Murea, MDPrincipal InvestigatorWake Forest University Health Sciences

4 Previous Clinical Trials

497 Total Patients Enrolled

Frequently Asked Questions

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

Are we currently enrolling participants for this drug trial?

"This trial, which was originally posted on June 19th 2019 and last updated on June 22nd 2022, is actively searching for candidates."

Answered by AI

What are the guidelines for this clinical trial's success?

"The aim of this experiment, which will last for a maximum of 24 months, is to study the Recruitment rate. Additionally, this trial will compare Monthly spKt/Vurea and stdKt/Vurea in the first quarter of hemodialysis between two treatment groups as a secondary outcome. Quality of Life- KDQOL-SF36 questionnaire will also be utilized as a metric to measure kidney disease burden, symptoms, and effects while Change in residual kidney function tracks renal urea clearance over time."

Answered by AI

How many people are in this experiment?

"The listings on clinicaltrials.gov show that this study is still recruiting patients. This particular trial was first posted on June 19th, 2019 and was last updated June 22nd, 2020. They are looking for a total of 50 participants across 1 location."

Answered by AI

Are there any similar studies to this one that have already been completed?

"4 clinical trials concerning hemodialysis are currently underway. Out of those 4, 2 have reached Phase 3. Although the majority of these trials take place in Durham, North carolina, 25 total locations across the country are running similar studies."

Answered by AI

Has Hemodialysis been cleared by the FDA?

"Hemodialysis received a score of 3 because, while this is only a Phase 3 trial, there is both some efficacy data and multiple rounds of safety data."

Answered by AI