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:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT06398002
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years.
* Treatment with thrice-weekly maintenance HD for ESKD for \> 3 months.
* Dialysate calcium of 1.25 mmol/L (standard concentration).
* Plasma ionised calcium \< 1.35 mmol/L (average of last 3 months).
* Plasma intact PTH \> 14 ρmol/L.
* Plasma total alkaline phosphatase \>90 U/L
* Negative pregnancy test and use of highly effective and safe contraception.
* Able to give written informed consent.
Exclusion Criteria:
* Treatment with peritoneal dialysis.
* Clinical bone fracture within the last 6 months.
* Treatment with bisphosphonates, denosumab, romosozumab, or teriparatide within the last 3 months.
* Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of the trial.
* Pregnancy or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06398002
Study Brief:
Protocol Section:
NCT06398002