Treatment for Hyperkalemia

Mountain Kidney & Hypertension Associates, Asheville, NC
All Sexes
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Study 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.

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 8-week Treatment Phase-1 and the 8-week Treatment Phase-2 dialysate cross-over periods

8-week Treatment Phase-1 and the 8-week Treatment Phase-2 dialysate cross-over periods
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.
Frequency and duration of CSCAs (bradycardia, ventricular tachycardia and/or asystole)
Number of events (measured promptly prior to the termination of dialysis) where a Piccolo POCT measurement of K+ is < 3.5 mEq/L OR Ca++ is < 7.0 mEq/L, OR Mg++ is < 2.0 mg/dl, OR a PO4 level is <3.0 mEq/L
The change in atrial Fibrillation events
Whether or not K+ outside of the 4.0 to 5.5 mEq/L safety range (Yes/No binary outcome measure).

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

0 Treatment Group

88 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · Phase 4

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8-week treatment phase-1 and the 8-week treatment phase-2 dialysate cross-over periods

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,053 Previous Clinical Trials
240,385,146 Total Patients Enrolled
30 Trials studying Hyperkalemia
72,902 Patients Enrolled for Hyperkalemia
NephroNet, Inc.Lead Sponsor
2 Previous Clinical Trials
34 Total Patients Enrolled
James Tumlin, MDPrincipal InvestigatorNephroNet, Inc.
2 Previous Clinical Trials
79 Total Patients Enrolled
Jeremy Whitson, BSStudy DirectorNephroNet, Inc.
1 Previous Clinical Trials
34 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

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

"Per, 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.