Status:
TERMINATED
Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease
Lead Sponsor:
AstraZeneca
Conditions:
Hyperkalaemia
Metabolic Acidosis
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
Brief Summary
The main objective of this study is to evaluate the efficacy of SZC as compared to placebo in maintaining normal sK+ in patients with hyperkalemia and metabolic acidosis associated with CKD
Detailed Description
NEUTRALIZE is a prospective, randomized, double-blind, placebo-controlled, parallel, multicenter, Phase IIIb study to investigate the safety and efficacy of SZC in patients with hyperkalemia and low b...
Eligibility Criteria
Inclusion
- Adults aged ≥18 years
- Participants who have CKD stage 3-5, not on dialysis.
- POCT K+ level \>5 mmol/L to ≤5.9 mmol/L and POCT bicarbonate levels between 16-20 mmol/L inclusive prior to the first SZC dose on study Day 1
- Ability to have repeated blood draws or effective venous catheterization.
- Male and/or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent
Exclusion
- Participants with pseudohyperkalemia.
- Dialysis requirement or anticipated by the investigator to require dialysis therapy within 1 month, history of renal transplant, or life expectancy less than 3 months.
- Cardiac arrhythmias requiring immediate treatment.
- Active or suspected diabetic ketoacidosis.
- POCT bicarbonate low enough to need emergency intervention or treatment as judged by the investigator.
- Acute/chronic worsening renal function (eg, ≥30% decline in eGFR) in the 3 months before screening.
- Current acute decompensated HF, hospitalization due to decompensated HF within 4 weeks prior to screening, or myocardial infarction (MI), unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to screening.
- Coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\]) or valvular repair/replacement within 12 weeks prior to screening or planned to undergo any of these operations.
- Symptomatic hypotension.
- Current exacerbation of chronic obstructive pulmonary disease (COPD)/asthma or hospitalization due to exacerbation of COPD/asthma within 4 weeks of screening.
- Severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders
- Active malignancy requiring treatment.
- History of QT prolongation associated with other medications that required discontinuation of that medication.
- Congenital long QT syndrome.
- Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Patients with atrial fibrillation controlled by medication are permitted.
- QTcF (QT interval corrected by the Fridericia method) \>550 msec.
- Active treatment (within 7 days prior to screening) with SZC, sodium bicarbonate, sodium polystyrene sulfonate, lactulose, or patiromer
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2022
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04727528
Start Date
March 22 2021
End Date
September 14 2022
Last Update
October 6 2023
Active Locations (30)
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1
Research Site
Florence, Alabama, United States, 35630
2
Research Site
Chula Vista, California, United States, 91910
3
Research Site
Downey, California, United States, 90242
4
Research Site
El Centro, California, United States, 92243