Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT06352957
Eligibility Criteria:
Inclusion Criteria:
1. Patient has provided informed consent;
2. Patient is 18 years of age or older of both gender;
3. Patients receiving maintenance HD three times per week (Kt/V \>1.2);
4. Parathyroid hormone concentrations \>500 ng/l at screening, or if parathyroidectomy is planned or expected, Ca \>8.3 mg/dl;
5. Will be considered patients in the exposed group:
1. Patients who have started Etelcalcetide within 1-month before the study enrolment;
2. Patients naïve to intravenous calcimimetics use;
3. Patients who have suspended oral calcimimetics from at least 1-month;
4. Patients who are not responder or not compliant to the treatment with calcitriol;
6. In the unexposed group, patients on treatment with calcitriol or vitamin D analogs and who are age (± 2 years) and sex comparable (matching) to those in the exposed group will be considered;
7. Native vitamin D can be used in both groups and should be administered to target a 25(OH)D level \> 30 ng/ml;
8. Dialysate calcium concentration must be stable for at least 4 weeks prior to screening laboratory assessments;
9. Patient must have severe HPT as defined by two laboratory screening pre-dialysis serum PTH values \> 500 pg/ml, measured on two consecutive lab checks prior to entering the study. PTH levels should be standardized according to the following table (Souberbielle et al. Kidney Int 2010);
10. Total alkaline phosphatase greater than the normal range, or even within the normal range but if greater than the tertile of the reference range for the assay;
11. Patients will be eligible only if they will show at least a moderate Aorta VCs and/or Iliac arteries VCs and at least a mild VF.
Exclusion Criteria:
1. Previous treatment with oral calcimimetics (cinacalcet) must have been suspended for at least 30 days. Recent start of calcimimetics (Etelcalcetide) is acceptable, but patients are excluded if treatment lasts for more than 1 month;
2. Patients has received a bisphosphonate, denosumab or teriparatide during the 12 months prior to screening;
3. The patient underwent parathyroidectomy in the 6 months before the start of the study or if scheduled soon;
4. Scheduled kidney transplant during the study period or anticipated living donor evaluation within three months of recruitment;
5. Patient has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator;
6. Metabolic bone diseases not related to the kidney (i.e., Pagets, Osteogenesis Imprefecta);
7. Severe untreated hyperthyroidism;
8. Malignancy within the last 3 years (except non-melanoma skin cancers or cervical carcinoma in situ);
9. Patient is pregnant or nursing;
10. Patients with Long QT Syndrome;
11. Patient likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the patient and Investigator's knowledge.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06352957
Study Brief:
Protocol Section:
NCT06352957