Phase III, multicenter, open-label, randomized clinical trial to evaluate efficacy of Sodium Zirconium Cyclosilicate (Lokelma) compared to standard of care to manage hyperkalemia in patients with chronic kidney disease (CKD) and heart failure history

Instituto de Investigación Sanitaria INCLIVA0 sites78 target enrollmentDecember 17, 2021

ConditionsHyperkalemia in patients with chronic kidney disease (CKD) and heart failure history MedDRA version: 21.1Level: LLTClassification code 10020647Term: HyperkalemiaSystem Organ Class: 100000004861 MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0Level: LLTClassification code 10019285Term: Heart failure, unspecifiedSystem Organ Class: 100000004849 Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

DrugsLokelma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hyperkalemia in patients with chronic kidney disease (CKD) and heart failure history
Sponsor: Instituto de Investigación Sanitaria INCLIVA
Enrollment: 78
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 17, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Instituto de Investigación Sanitaria INCLIVA

Eligibility Criteria

Inclusion Criteria

•1\. Patients must present serum potassium levels of 5\.5\-6\.5 mEq/L at the day of inclusion.
•2\. Provision of patient or legal representative informed consent prior to any study specific procedures.
•3\. Previous history of heart failure (cardiorenal syndrome) established as a HF diagnose which has been present for at least 3 months.
•4\. Individuals receiving background standard of care for HF and treated according to locally recognized guidelines. Specific treatment should include RAASi and/or MRA treatment at first consultation and at least should have been stable for \= 4 weeks at maximum tolerated doses.
•5\. Patients with CKD not on dialysis (Stages 2\-5: estimated glomerular filtration rate (eGFR) between 15\-60 ml/min/1,73m2 or eGFR between 60\-90 ml/min/ 1\.73 m2 with albuminuria/creatinuria (\> 30 mg/g) in the previous three months). The estimated GFR can be reported by the laboratory or calculated by the researcher with serum creatinine, age, and sex (CKD\-EPI equation).
•6\. At least 18 years at the time of signing ICF.
•7\. Negative pregnancy test (urine or serum) for female subjects of childbearing potential.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•1\. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
•2\. Previous enrollment or randomization in the present study.
•3\. HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease.
•4\. Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrollment.
•5\. Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting or valvular repair/replacement within 12 weeks prior to enrollment or planned to undergo any of these operations after randomization).
•6\. Implantation of a Cardiac Resynchronization Therapy (CRT) device or Implantable Cardioverter Defibrillator (ICD) within 12 weeks prior to enrollment or intent to perform atrial fibrillation ablation or to implant a CRT or ICD device.
•7\. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or transplantation or implantation expected after randomization
•8\. Oropharingeal dysfunction that precludes normal swallow.
•9\. Female who is pregnant, breast\-feeding or intends to become pregnant or is of child\-bearing potential and not using a highly effective contraceptive method.
•10\. Patients with amputated limbs or pacemaker devices will be excluded of bioimpedance analysis.