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

PHASE4CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

April 14, 2022

Primary Completion Date

April 1, 2024

Study Completion Date

April 1, 2024

Conditions
Hyperkalemia
Interventions
DRUG

LOKELMA 5 GM Powder for Oral Suspension

Patients will use Lokelma supplementation on off-dialysis days (4 days/week) while receiving hemodialysis with 3.0 K+/2.5 Ca++ mEq dialysate bath. The individual starting dose will be 5.0 grams, and may be titrated weekly in 5.0 gram increments up to 15.0 grams to maintain K+ between 4.0 and 5.5 mEq/L.

Trial Locations (5)

28801

Mountain Kidney & Hypertension Associates, Asheville

30046

Georgia Nephrology DBA Georgia Nephrology Research Institute, Lawrenceville

46804

Nephrology Associates of Northern Illinois and Indiana (NANI), Fort Wayne

64111

Clinical Research Consultants, Kansas City

92024

Balboa Research, La Jolla

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

NephroNet, Inc.

OTHER