Phase 3 Chronic Kidney Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People whose blood potassium level was between 5.5 and 6.5 mEq/L at their first screening visit, and between 5.0 and 6.5 mEq/L at the follow-up visit when treatment is assigned.
• People who have given their written agreement (or whose legal representative has done so) to take part before any study procedures begin.
• People already receiving standard treatment for heart failure following recognised local guidelines, including at least one medication from a group called RAASi and/or MRA, at the highest dose they can tolerate, and on a stable dose for at least 4 weeks.
• People with chronic kidney disease (CKD stages 2–5) who are not on dialysis, with kidney function or protein levels in the urine falling within specific ranges measured in the past three months (confirm with trial site for exact values).
• People aged 18 or older at the time of signing the consent form.
• Women who could become pregnant must have a negative pregnancy test (urine or blood) before joining.
• Women who could become pregnant must be using an acceptable form of contraception for the whole study and for 3 months after the last dose of study medication — acceptable methods include a barrier method used together with a spermicide, and may also include the pill, implants, long-acting injections, an intrauterine device (IUD), or tubal ligation; however, the pill alone is not sufficient and must be combined with a barrier method and spermicide.

Who may not be able to join:

• People who were involved in planning or running this study.
• People who have previously been enrolled or randomised into this same study.
• People whose heart failure is caused by specific heart conditions, including restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or uncorrected primary valve disease.
• People who have had a severe worsening of heart failure requiring hospitalisation, a heart attack, unstable chest pain, stroke, or a mini-stroke (TIA) within the 12 weeks before joining.
• People who have had heart bypass surgery, a stent procedure, or heart valve repair or replacement within the 12 weeks before joining, or who have any of these procedures planned after the treatment assignment date.
• People who have had a heart rhythm device (CRT or ICD) implanted within the 12 weeks before joining, or who have a planned procedure to treat atrial fibrillation or implant one of these devices.
• People who have previously had a heart transplant or had a mechanical heart-assist device implanted, or for whom either is expected after the treatment assignment date.
• People who have difficulty swallowing normally.
• Women who are pregnant, breastfeeding, planning to become pregnant, or who could become pregnant and are not using a sufficiently effective method of contraception.
• People with amputated limbs or a pacemaker device will not be included in the body fluid measurement part of the study.
• People who have taken part in another clinical trial involving an experimental treatment within the past 6 months.
• People with a known allergic reaction to the study drug (SZC) or any of its ingredients.
• People who have taken certain other potassium-lowering medications (such as Kayexalate, Resonium, or Veltassa) within 7 days before the first dose of the study drug.
• People whom the trial doctor believes are unlikely to follow the study procedures and requirements.
• People with a family history of a heart rhythm condition called long QT syndrome, or who currently have certain heart rhythm problems requiring immediate treatment, or whose heart trace (ECG) shows a specific measurement (QTc) of 550 milliseconds or more.
• People who previously had to stop another medication because it caused a heart rhythm problem called QT prolongation.
• People with atrial fibrillation that is causing symptoms or is not controlled by treatment, or who have a sustained fast heart rhythm from the lower chambers of the heart (ventricular tachycardia) without symptoms; people with atrial fibrillation that is well controlled by medication may still be eligible (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.