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:

• A parent or legal guardian must have given written consent, and the child must have given written agreement to participate, before any trial activities begin.
• Children and teenagers aged 2 years old up to (but not including) 18 years old at the time of joining.
• The child's target dry body weight must be at least 7 kg at the time of initial screening.
• The child must have been diagnosed with chronic kidney disease (CKD) and a parathyroid gland condition called secondary hyperparathyroidism (SHPT), and must have been receiving a type of kidney dialysis (hemodialysis or hemodiafiltration) three or four times per week for at least one month before screening.
• Blood test results from the trial's central laboratory must show that a hormone called iPTH is above 300 pg/mL across two separate tests taken on different days within two weeks of joining.
• A blood calcium level of at least 9.0 mg/dL, measured by the trial's central laboratory during screening.
• The calcium level in the dialysis fluid must have been at least 2.5 mEq/L for at least one month before screening and must stay at that level throughout the trial.
• Children taking active vitamin D medications must have had no more than a 50% change in dose in the two weeks before screening blood tests, must remain on a stable dose through enrollment, and must be expected to stay on a stable dose for the whole trial (with some exceptions allowed by the trial rules).
• Children taking phosphate binder medications must have had no more than a 50% change in dose in the two weeks before screening blood tests, must remain on a stable dose through enrollment, and must be expected to stay on a stable dose for the whole trial (with some exceptions allowed by the trial rules).
• Children taking calcium supplements must have had no more than a 50% change in dose in the two weeks before screening blood tests, must remain on a stable dose through enrollment, and must be expected to stay on a stable dose for the whole trial (with some exceptions allowed by the trial rules).
• The parathyroid condition must not be caused by a vitamin D deficiency, as determined by the treating doctor.

Who may not be able to join:

• Children with a history of certain heart rhythm conditions, including a condition called long QT syndrome (present from birth), second or third degree heart block, dangerous irregular heartbeats, or other conditions known to affect the heart's electrical timing.
• Children who are expected to have their parathyroid glands surgically removed 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 six months before joining.
• Children who currently have cancer or who have had cancer in the past five years, with the exception of certain common skin cancers (non-melanoma skin cancers).
• Children who are taking certain medications known to affect the heart's electrical rhythm — such as ondansetron, albuterol, sotalol, amiodarone, erythromycin, or clarithromycin — though the trial's medical team may allow some of these on a case-by-case basis with additional monitoring.
• Children who have taken a medication called cinacalcet within 30 days before screening through to the time of enrollment.
• Children who have ever previously taken the trial drug etelcalcetide (this applies under certain versions of the trial protocol — confirm with trial site).
• Children who have taken etelcalcetide within the six months before screening (this applies under later versions of the trial protocol — confirm with trial site).
• Any herbal medicines, vitamins, or supplements taken in the 30 days before joining must be reviewed and approved by the principal investigator and the trial sponsor's medical team before the child can participate.
• Any over-the-counter or prescription medications taken in the 14 days (or five half-lives, whichever is longer) before joining that are not standard treatments for kidney disease must be reviewed and approved by the principal investigator and the trial sponsor before the child can participate (paracetamol for pain relief is permitted).
• Children who are currently in another clinical trial, or who finished another clinical trial less than 30 days ago.
• Children whose most recent screening blood tests show certain significant abnormalities, including liver enzyme levels (ALT or AST) greater than 1.5 times the upper normal range.
• Children whose heart's electrical measurement (corrected QT interval) is greater than 500 ms on an electrocardiogram (ECG), using a standard calculation method.
• Children whose corrected QT interval is between 450 ms and 500 ms, unless a children's heart specialist reviews the case and the investigator provides written permission to enroll (confirm with trial site).
• Children who have a significant abnormal ECG result during screening that the investigator believes could affect their safety or the trial's results.
• Children who have had a new seizure or a worsening of an existing seizure condition within the three months before screening.
• Children taking anti-seizure medications must have been on a stable and effective dose for at least three months before screening, and if blood level monitoring is available, must have a therapeutic blood level within one week of joining.
• Girls who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the trial or within three months after the last dose of the trial drug.
• Girls who could potentially become pregnant and are unwilling to use an effective method of contraception during the trial and for three months after the last dose of the trial drug.
• Girls who could potentially become pregnant and who have a positive pregnancy test at screening.
• Children who are known to have a sensitivity or allergy to etelcalcetide or any of its ingredients.
• Children who are unlikely to be able to attend all required trial visits or follow all required trial procedures.
• Children with any other significant health condition or disorder that, in the investigator's opinion, could affect their safety or interfere with the trial.
• Children who have previously participated in this specific trial (confirm with trial site for which protocol version applies).
• Children with anaemia severe enough that the investigator considers it unsafe to have repeated blood draws during the trial.
• Children with a history of unstable chronic heart failure within the one year before screening.

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