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

Phase 4

Recruiting

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

ADAPT 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.

ADAPT Trial 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

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

Primary outcome measures

The change in atrial Fibrillation events

Secondary outcome measures

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 outcome measures

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

ADAPT 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.

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Find a Location

Who is running the clinical trial?

NephroNet, Inc.Lead Sponsor

2 Previous Clinical Trials

34 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,259 Previous Clinical Trials

288,593,814 Total Patients Enrolled

32 Trials studying Hyperkalemia

72,726 Patients Enrolled for Hyperkalemia

James Tumlin, MDPrincipal InvestigatorNephroNet, Inc.

2 Previous Clinical Trials

79 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 there any opportunities to participate in this experiment currently available?

"Per clinicaltrials.gov, this trial is still enrolling candidates and was initially posted on April 14th 2022 with its latest update coming October 27th of the same year."

Answered by AI

What are the associated risks of this curative measure?

"As this treatment is already approved, there is a high degree of confidence in its safety; thus it received score 3 on our rating scale."

Answered by AI

Are there any sites in North America executing this trial?

"This trial has 5 potential sites of enrollment, such as Georgia Nephrology DBA Georgia Nephrology Research Institute in Lawrenceville, Nephrology Associates of Northern Illinois and Indiana (NANI) in Fort Wayne, and Clinical Research Consultants in Kansas City."

Answered by AI

How many individuals are currently involved in this research endeavor?

"AstraZeneca has set a target of 88 participants to partake in this trial. The research is being conducted from two separate locations, the Georgia Nephrology Research Institute located in Lawrenceville, GA and NANI situated in Fort Wayne, IN."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Prospective, Randomized, Open-Label, Cross-Over Study of Lokelma to Control Interdialytic Hyperkalemia

2022. "A Prospective, Randomized, Open-Label, Cross-Over Study of Lokelma to Control Interdialytic Hyperkalemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05535920.