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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 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

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%

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

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