Status:
RECRUITING
Keeping RAASi Treatment With Optimal Potassium Control
Lead Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Phase III, multicenter, randomized, open-label, parallel-group, non-inferiority, phase III clinical trial comparing CSZ (Lokelma) vs. iSRAA discontinuation/reduction and/or ARM (standard treatment).
Detailed Description
Hyperkalemia is a potentially life-threatening condition associated with ventricular arrhythmias and sudden cardiac arrest. It is common in patients with some comorbidities such as chronic kidney dise...
Eligibility Criteria
Inclusion
- Patients must present serum potassium levels of 5.5-6.5 mEq/L at patient selection visit (V0)
- Patients must present serum potassium levels of 5.0-6.5 mEq/L at randomization visit (V1).
- Provision of patient or legal representative informed consent prior to any study specific procedures.
- 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.
- 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).
- 18 years at the time of signing ICF.
- Negative pregnancy test (urine or serum) for female subjects of childbearing potential.
- Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign ICF) and for 3 months after the last dose of SZC. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
Exclusion
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
- Previous enrollment or randomization in the present study.
- HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease.
- Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrollment.
- 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).
- 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.
- Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or transplantation or implantation expected after randomization
- Oropharingeal dysfunction that precludes normal swallow.
- 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.
- Patients with amputated limbs or pacemaker devices will be excluded of bioimpedance analysis.
- Participation in another clinical study with an investigational product during the last 6 months.
- Patients with a known hypersensitivity to SZC or any of the excipients of the product.
- Treated with potassium binding resins such as sodium polystyrene sulfonate (SPS; e.g. Kayexalate®) or calcium polystyrene sulfonate (CPS; e.g. Resonium®) or the cation exchange polymer, patiromer sorbitex calcium (Veltassa®), within 7 days prior to the first dose of study drug.
- Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
- Subjects with a family history of long QT syndrome, presence of cardiac arrhythmias or conduction defects that require immediate treatment, or a QTc (corrected QT interval) of ≥ 550 msec.
- History of QT prolongation associated with other medications that required discontinuation of that medications.
- Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.
Key Trial Info
Start Date :
September 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06578533
Start Date
September 30 2022
End Date
July 30 2026
Last Update
August 29 2024
Active Locations (5)
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1
Hospital General Universitario Dr. Balmis
Alicante, Spain, 03010
2
Hospital Universitario Vall d'Hebrón
Barcelona, Spain, 08035
3
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
4
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010