Phase 3 Chronic Kidney Disease Trial, Recruiting

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

Who might be able to join this trial:

• Children aged from 28 days old up to (but not including) 18 years old.
• Children who weigh at least 7 kg (approximately 15.4 lbs) at the time of screening.
• Children who have been diagnosed with chronic kidney disease (CKD) and a condition called secondary hyperparathyroidism (SHPT), and who are currently receiving dialysis through a machine (hemodialysis).
• Children whose blood tests show a specific hormone related to the parathyroid gland (iPTH) is at a high level (at or above 300 pg/mL), confirmed by two separate tests taken on different days within 2 weeks of joining.
• Children whose blood calcium levels meet certain minimum levels during screening — the exact minimum level required depends on the child's age (confirm with trial site).
• Children whose dialysis fluid (dialysate) has contained a certain minimum level of calcium for at least 4 weeks before screening, continuing throughout the trial.
• Children whose doses of certain related medications (active vitamin D, phosphate binders, or calcium supplements) have not changed by more than 50% in the 2 weeks before screening, and have remained stable.
• Children whose overactive parathyroid glands are not caused by vitamin D deficiency, as assessed by the treating doctor.

Who may not be able to join:

• Children with a history of certain heart rhythm conditions, including a condition called congenital long QT syndrome, certain types of heart block, or other conditions linked to abnormal heart rhythm.
• Children who are expected to have their parathyroid glands surgically removed (parathyroidectomy) at any point during the trial.
• Children who are expected to receive a kidney transplant at any point during the trial.
• Children who have had their parathyroid glands surgically removed within the 6 months before joining the trial.
• Children with a history of most types of cancer within the last 5 years (certain skin cancers or early-stage cancers may be exceptions — confirm with trial site).
• Children currently taking certain medications that can affect heart rhythm (such as some antibiotics or heart medications — the trial site can review specific medications).
• Children who have received a medication called cinacalcet within 30 days before screening.
• Children who have received a medication called etelcalcetide within 6 months before screening.
• Children currently taking herbal medicines, vitamins, or supplements — these will be reviewed by the doctor and the trial sponsor before a decision is made about eligibility.
• Children taking certain non-standard medications not typically used for kidney disease or related conditions — these will be reviewed by the doctor and trial sponsor (paracetamol for pain relief is generally allowed).
• Children who are currently taking part in another clinical trial of an investigational drug or device, or who finished such a trial less than 30 days ago (or within 5 half-lives of the drug, whichever is longer).
• Children whose recent blood tests show significant abnormalities, including certain liver enzyme levels more than twice the upper limit of normal.
• Children whose heart tracing (ECG) shows a measurement called the QTc interval above 500 ms.
• Children whose QTc interval is between 450 and 500 ms, unless a specialist children's heart doctor reviews the case and provides written approval.
• Children who show other significant abnormalities on their heart tracing (ECG) during screening that the doctor considers a safety concern.
• Children who have had a new or worsening seizure disorder in the 60 days before joining the trial.
• Babies aged 28 days to 6 months who were born prematurely at less than 36 weeks of pregnancy.
• Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the treatment period and for 3 months after the last dose.
• Females of childbearing potential who are unwilling to use an acceptable form of contraception during treatment and for 3 months after the last dose.
• Children known to have an allergy or sensitivity to etelcalcetide or any of its ingredients.
• Children who are unlikely to be able to attend all required trial visits or follow all trial procedures.
• Children with any other significant health condition that, in the doctor's opinion, could affect their safety or the trial results.
• Children who have previously taken part in this same trial.

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