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Rate Atrial fibrillation - 3.0K+ dialysate bath w/ 5 grams Lokelma to crossover for Hyperkalemia (ADAPT Trial)

Phase 4

Waitlist Available

Led By James Tumlin, MD

Research Sponsored by NephroNet, Inc.

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 8-week treatment phase-1 and the 8-week treatment phase-2 dialysate cross-over periods

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new drug to see if it can help control potassium levels in people receiving dialysis. The goal is to reduce the incidence of heart arrhythmias.

Eligible Conditions

Hyperkalemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8-week treatment phase-1 and the 8-week treatment phase-2 dialysate cross-over periods

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8-week treatment phase-1 and the 8-week treatment phase-2 dialysate cross-over periods

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-week treatment phase-1 and the 8-week treatment phase-2 dialysate cross-over periods for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The change in atrial Fibrillation events

Secondary study objectives

Frequency and duration of CSCAs (bradycardia, ventricular tachycardia and/or asystole)

Whether or not K+ outside of the 4.0 to 5.5 mEq/L safety range (Yes/No binary outcome measure).

Other study objectives

Correlation between PBUTs (IS, PCS, and ADMA) and the frequency of atrial fibrillation events.

Correlation between electrolyte levels and clinical events (intradialytic hypotension, muscle cramping, and cardiac events). Correlation between electrolytes falling below threshold levels

Frequencies of AEs, SAEs, and withdrawals due to AEs, with focus on treatment-related events.

+2 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

Group I: Rate Atrial fibrillation - 3.0K+ dialysate bath w/ 5 grams Lokelma to crossoverExperimental Treatment1 Intervention

• Sequence B: experimental 3.0 K+/2.5 Ca++ dialysate with 5 grams Lokelma supplementation (on off-dialysis days) for two (2) months, followed by standard 2.0 K+/2.5 Ca++ dialysate with no Lokelma supplementation for two (2) months. Each two-month treatment period (both 2.0 K+/2.5 Ca++ dialysate and 3.0 K+/2.5 Ca++ dialysate with Lokelma sequences) will be preceded by a two-week run-in period, to allow the patient to adapt to the new dialysate bath. While receiving the higher K+ dialysate, patient will be treated on off-dialysis days (4 days/week) with Lokelma, titrated to maintain K+ between 4.0 and 5.5 mEq/L. Refer to section 7.2 for the initial dose and frequency details.

Group II: Rate Atrial fibrillation - 2.0K+ dialysate bath wo/ Lokelma to crossoverExperimental Treatment1 Intervention

Sequence A: standard 2.0 K+/2.5 Ca++ dialysate with no Lokelma supplementation for two (2) months, followed by a cross-over to experimental 3.0 K+/2.5 Ca++ dialysate with 5 grams powder oral suspension Lokelma supplementation (on off-dialysis days) for two (2) months. Each two-month treatment period (both 2.0 K+/2.5 Ca++ dialysate and 3.0 K+/2.5 Ca++ dialysate with Lokelma sequences) will be preceded by a two-week run-in period, to allow the patient to adapt to the new dialysate bath. While receiving the higher K+ dialysate, patient will be treated on off-dialysis days (4 days/week) with Lokelma, titrated to maintain K+ between 4.0 and 5.5 mEq/L. Refer to section 7.2 for the initial dose and frequency details.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LOKELMA 5 GM Powder for Oral Suspension

2022

Completed Phase 4

~90

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