Phase 2 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 willing to sign a consent form and follow all study requirements
• People who have been receiving hemodialysis (including hemodialysis, hemodiafiltration, or hemoadsorption) three times per week for at least 12 weeks, with no plans to change this during the study
• People whose blood phosphate level falls within the range required by the study
• People whose dialysis is working adequately, based on a specific blood test measurement (SpKt/V ≥1.20) either at screening or within the 12 weeks before signing the consent form
• People taking a medication called etelcalcetide, whose dose has not changed for at least 4 weeks before signing the consent form
• People taking certain other medications (such as some phosphate-lowering products, active vitamin D, cinacalcet, calcitonin, or certain other drugs), whose doses have been stable for at least 14 days before signing the consent form
• People who agree to use highly effective contraception throughout the study and for 90 days after the last dose of the study drug (applies to women who could become pregnant and sexually active males who have not had a sterilisation procedure)

Who may not be able to join:

• People who are pregnant or breastfeeding
• People who are scheduled for a living donor kidney transplant within the next 6 months, plan to switch to peritoneal dialysis or home hemodialysis during the study, or plan to move to a different dialysis centre during the study
• People who have had a non-medication-based procedure on their parathyroid glands within the past 6 months, or who have one planned during the study
• People with certain abnormal levels of calcium or parathyroid hormone in their blood
• People whose organ or bone marrow function does not meet the study's required levels (confirm with trial site)
• People with active hepatitis or significant long-term liver disease
• People who have had significant digestive system problems within the past 4 weeks, a history of stomach removal surgery, or any digestive tract surgery (other than appendix removal or polyp removal) within the past 12 weeks
• People with uncontrolled high blood pressure
• People who were hospitalised for a heart or stroke-related condition within the past 24 weeks
• People with significant abnormalities in heart rhythm or electrical activity, as shown on a heart tracing (ECG) test
• People with a significant active infection or infestation, or who have taken antibiotic, antiviral, or antifungal medication within the past 2 weeks
• People with a history of cancer diagnosed within the past 3 years, with the exception of certain low-risk skin cancers, early-stage cervical cancer, or early-stage prostate cancer
• People who have taken certain medications that affect how the body processes drugs (moderate or strong CYP3A inhibitors) within the past 2 weeks or 5 half-lives of that drug, whichever is longer (topical/skin-applied versions are generally allowed)
• People who have taken part in another clinical trial or used an experimental medical device within the past 30 days
• People whose life expectancy is less than 12 months

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