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Hemodialysis for Kidney Failure (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
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test different treatment plans for patients with severe kidney disease to see which is more effective in maintaining kidney function.

Eligible Conditions
  • Kidney Failure

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patients' Adherence to Study Protocol
Secondary study objectives
24-hour Urine Volume
Change in Residual Kidney Function - Creatinine Clearance
Change in Residual Kidney Function - Urea Clearance
Other study objectives
Long-term change in residual kidney function
Survival

Side effects data

From 2021 Phase 3 trial • 51 Patients • NCT03740048
27%
hospitalization
18%
Hospitalization
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hemodialysis and Pharmacologic Therapy
Conventional Hemodialysis Regimen

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,394 Previous Clinical Trials
2,459,985 Total Patients Enrolled
2 Trials studying Kidney Failure
5,030 Patients Enrolled for Kidney Failure
Mariana Murea, MDPrincipal InvestigatorWake Forest University Health Sciences
4 Previous Clinical Trials
497 Total Patients Enrolled
~8 spots leftby Nov 2025
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