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

  • STATUS
    Recruiting
  • days left to enroll
    16
  • participants needed
    88
  • sponsor
    NephroNet, Inc.
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Updated on 7 October 2022
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Summary

A Prospective, RanDomized, Multi-Center, Open-Label, Cross-Over Study of Sodium Zirconium Cyclosilicate to Control Interdialytic HyperkalemiA Following Augmentation of Dialysate Potassium: Efficacy to Reduce the Incidence of Post-Dialysis Atrial Fibrillation and Clinically SignificanT Cardiac Arrhythmias - ADAPT Trial

Description

This is a prospective, open-labelled, randomized, 2x2 cross-over design study of 88 patients with end stage renal disease (ESRD) receiving routine out-patient dialysis using a standard 2.0 potassium ion (K+)/2.5 calcium ion (Ca++) dialysate bath. The overall aim of the study is to determine whether converting stable hemodialysis patients from a "standard" 2.0 K+/2.5 Ca+ dialysate (without Lokelma) to a 3.0 K+/2.5 Ca++ mEq dialysate supplemented with the orally administered potassium binder sodium zirconium cyclosilicate (Lokelma) to treat interdialytic hyperkalemia will reduce the incidence and duration of post-dialysis atrial fibrillation.

Details
Condition Hyperkalemia
Treatment LOKELMA 5 GM Powder for Oral Suspension
Clinical Study IdentifierNCT05535920
SponsorNephroNet, Inc.
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Provision of informed consent prior to any study-specific procedures
Female or male aged above 18 years
Patients with ESRD receiving hemodialysis three times per week for a minimum of 3 months
Patients must have two (2) pre-dialysis K+ measurements between 5.1 and 6.5 mEq/L by Piccolo POCT following the long dialytic "weekends" (i.e., on two consecutive Mondays for patients on a Monday-Wednesday-Friday dialysis schedule or on two consecutive Tuesdays for patients on a Tuesday-Thursday-Saturday dialysis schedule) during screening, before insertion of the cardiac loop recorder
Female participants must be 1 year post-menopausal, surgically sterile, or using one highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly.) They should have been stable on their chosen method of birth control for a minimum of 1 month before entering the study and willing to remain on the birth control until 4 weeks after the last dose

Exclusion Criteria

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Exclusion Criteria Related to the Underlying Condition
Patients with a QTc(f) > 550 msec and/or Congenital long QT syndrome
Patients with a Haemoglobin < 9 g/dl
Patients with any medical condition, including active, clinically significant infection or liver disease, that in the opinion of the investigator or Sponsor may pose a safety risk to a subject in this study, which may confound safety or efficacy assessment and jeopardize the quality of the data, or may interfere with study participation
Patient receiving peritoneal or home hemodialysis
Patient receiving hemodialysis via a tunneled inferior vena cava (IVC) catheter and known central stenosis of access extremity
Patient receiving outpatient hemodialysis for < 3 months
Patient receiving outpatient hemodialysis for prolonged Acute Kidney Injury (AKI) and considered by the site Principal Investigator (PI) likely to achieve renal recovery within 6 months Note: Patients receiving out-patient hemodialysis for AKI for longer than 6 months with no demonstrable renal clearance can be screened for study participation
Patient currently receiving a 1.0 K+, 3.0 K+ dialysate bath and unwilling to convert to a 2.0 K+/2.5 Ca++ dialysate bath
Subject unwilling to convert from a 2.0 K+ dialysate bath to a 3.0 K+ dialysate bath
Two or more pre-dialysis K+ of < 5.1 or > 6.5 mEq/L measured by Piccolo POCT after the long dialytic "weekends" during screening Note: If one of the two screening pre-dialysis K+ levels is between 4.6 to 5.0 mEq/L or 6.6 to 7.0 mEq/L, the patient can undergo an additional whole blood Piccolo POCT K+ measurement. Patients who fail the third whole blood Piccolo POCT K+ measurement will be considered ineligible for study participation. Note: Screen failures can be re-screened once to confirm eligibility in the study
Any documented whole blood Piccolo POCT K+ measurement that falls below 4.6 mEq/L or exceeds 7.0 mEq/l during the screening period
Current use of a medication for treatment of hyperkalemia (e.g., Patiromer)
Note: If a medication for treatment of hyperkalemia is stopped prior to or after the consenting process, the subject will undergo a one week washout prior to the first whole blood Piccolo POCT K+ measurement. Exclusion Criteria Related to Other Medical Conditions and Treatments
Anticipated life expectancy of 3 months duration
Development of atrial fibrillation requiring hospitalization, medical therapy, anticoagulation, or cardioversion during study pre-screening or screening period
Patient with a known placement of a dual or single chamber pacemaker
Patient with an automatic implantable cardiac defibrillator (AICD)
Patient with a LINQ implanted cardiac loop recorder with less than 6 months of battery life
Current use of amiodarone or other anti-arrhythmic therapy. Note: Patients on such medications must undergo a two week washout prior to the first whole blood Piccolo POCT K+ measurement
Known history of cardiac arrhythmias due to prolonged QT syndrome
Subject unwilling to receive an implanted LINQ cardiac loop recorder (unless 6 months are remaining in their previously implanted device)
Known active drug abuse
Positive hepatitis C polymerase chain reaction (PCR) test with active viral deoxyribonucleic acid (DNA) shedding or chronic active hepatitis B as evidenced by detectable surface antigen from standard of care routine dialysis labs. Note: Patients with negative PCR DNA testing for either hepatitis B or C will be allowed to participate in the study
Known to have tested positive for human immunodeficiency virus (HIV) from standard of care routine dialysis labs
For women only: currently pregnant (confirmed with positive pregnancy test) or breastfeeding
Patients with known and/or active severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders or diabetic gastroparesis Exclusion Criteria Related to the Investigational Product (IP)
Known hypersensitivity to sodium zirconium cyclosilicate (Lokelmaâ)
Other/General Exclusion Criteria
Previous randomization in the present study. Note: Screen failures can be re-screened once to confirm eligibility in the study
Participation in another interventional (non-observational) clinical study within 4 weeks prior to enrollment in the present study
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