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 able to understand written information and are willing to sign a written consent form agreeing to take part
• Adults aged 18 or older with a body mass index (a measure of body weight relative to height) between 18 and 35
• People who have been receiving regular dialysis three times a week for at least 12 weeks before the screening visit
• People whose dialysis fluid contains a calcium concentration of at least 1.25 mmol/L
• People who have been diagnosed with a condition called Secondary Hyperparathyroidism (overactive parathyroid glands caused by kidney disease), with a specific hormone level (iPTH) of 400 pg/mL or higher, confirmed by two blood tests taken on separate days within 14 days before joining the trial
• People whose blood calcium level is 8.4 mg/dL or higher, confirmed by two blood tests taken on separate days within 14 days before joining the trial

Who may not be able to join:

• People who had surgery to remove their parathyroid glands within the 6 months before screening, or who are expected to have that surgery, ablation, or radiation treatment during the trial
• People who have had stomach or intestinal bleeding, or a stomach ulcer, within the 6 months before screening
• People who have had severe heart failure (classified as NYHA Class III or IV) within the 3 months before screening, a significant irregular heartbeat within the 6 months before screening, or a history of a specific dangerous heart rhythm called torsades de pointes
• People whose heart electrical activity test (ECG) shows certain abnormalities, such as a prolonged electrical interval (QTcF above 470 ms for males or 480 ms for females) or other significant heart rhythm problems as determined by the trial doctor
• People with severely uncontrolled high blood pressure during screening (systolic pressure above 180 mmHg and/or diastolic pressure above 110 mmHg) that has not responded to appropriate medication, not counting temporary blood pressure changes during dialysis
• People who have had a seizure within the year before screening, or who are currently being treated for a seizure disorder
• People who have taken certain medications used to treat overactive parathyroid glands — specifically oral cinacalcet or ivocalcet within 14 days before screening, or etelcalcetide injections within 4 months before screening
• People who have any other medical condition that the trial doctor considers would make participation unsuitable

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