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 who are over 18 years old
• People who have been on stable dialysis three times per week for at least three months due to permanent kidney failure
• People whose blood potassium level (measured before dialysis, after the longest break between sessions) is between 4.0 and 5.5 mEq/L, confirmed across two consecutive weeks, with no signs or symptoms of high potassium
• People who have been on a stable dose of certain blood pressure or heart medications (called RAS inhibitors or MRAs) for at least three months, and are not taking potassium-sparing water tablets (diuretics)
• People who are following a low-potassium diet (either moderately or strictly restricted) as recommended
• People who are consistently sticking to their prescribed diet
• People who are willing and able to provide written consent to participate

Who may not be able to join:

• People whose blood potassium level is too high (above 5.5 mEq/L) before dialysis during the long break between sessions
• People with low magnesium levels in the blood (below 1.7 mg/dL)
• People with high calcium levels in the blood (above 10.5 mg/dL)
• People currently taking potassium-binding medications, such as Kayexalate® or Lokelma®
• People currently taking potassium-sparing water tablets (diuretics)
• People whose blood potassium level before dialysis is below 4.0 mEq/L during the long break between sessions
• People who attend dialysis only once or twice a week
• People who have not been consistently following their prescribed low-potassium diet
• People with a history of bowel blockage, major bowel surgery, serious digestive system problems, or difficulty swallowing
• People with a previous history of heart rhythm problems that may have been related to low potassium levels
• People with a known allergy to the study drug or any of its ingredients
• People who are unable to fully understand the possible risks and benefits of taking part in the study
• People with certain other health conditions that could affect the study, including:
  • Cancer (except certain non-spreading skin cancers)
  • Active autoimmune diseases affecting the whole body
  • Currently taking steroids or other immune-suppressing medications
  • Severe or unstable heart failure that required hospitalisation, medication changes, or extra dialysis sessions in the past three months
  • Very high blood pressure that remains above 180/100 mmHg despite taking at least three blood pressure medications at optimal doses
  • Known HIV-positive status
  • Current drug or alcohol misuse
• People who are pregnant, breastfeeding, planning to become pregnant during the study or within 90 days of the last dose of the study treatment
• People who plan to donate eggs or sperm during the same period
• People of childbearing potential who are not using highly effective contraception methods as defined by 2020 European clinical trial guidelines (confirm with trial site)
• People who were involved in planning or running this trial
• People who have participated in another clinical trial involving an experimental treatment within the last month

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