The Effect of Increasing Dialysate Calcium on T50 in Subjects With Secondary Hyperparathyroidism … (NCT06398002) | Clinical Trial Compass
UnknownPhase 2
The Effect of Increasing Dialysate Calcium on T50 in Subjects With Secondary Hyperparathyroidism and ESKD
48 participantsStarted 2024-08-01
Plain-language summary
Patients with end-stage kidney disease (ESKD) have an increased risk of cardiovascular mortality. High parathyroid hormone (PTH) from secondary hyperparathyroidism leads to increased efflux of phosphate and calcium from bone, which exacerbates vascular calcification and increases the risk of bone fractures. The main driving factor for secondary hyperparathyroidism is hypocalcaemia caused by low levels of 1,25-dihydroxy vitamin D and pharmacological supplementation with activated vitamin D and oral calcium-containing phosphate-binders are used to control secondary hyperparathyroidism. The amount of calcium used in this context is controversial, as higher calcium load in blood may theoretically increase vascular calcification. Conversely, by alleviating the efflux of phosphate and calcium from bone due to secondary hyperparathyroidism, increasing the load of calcium might actually prevent vascular calcification.
To study this further, we wish to conduct a randomised double-blinded controlled clinical trial of increasing dialysate Ca from 1.25 mmol/L (standard dialysate concentration) to 1.50 mmol/L in patients with ESKD and secondary hyperparathyroidism on maintenance haemodialysis (HD). The overall effect of increased dialysate calcium will be gauged by its effect on serum calcification propensity (T50) and on markers of bone turnover.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial, which means it's still in earlier stages of testing — can you help me understand what that means for how much is known about the safety of raising dialysate calcium levels in people with secondary hyperparathyroidism and end-stage kidney disease like me?
2The trial is measuring something called T50, which I understand reflects how likely my blood is to form harmful calcium deposits — can you explain what my current T50 level might be and whether this is something worth trying to improve given my specific situation?
3Since the study involves changing the calcium concentration in my dialysis fluid, what risks should I be aware of around heart rhythm or cardiovascular problems, which I know can already be a concern for people on dialysis?
4The recruitment status for this trial is listed as unknown, so can you find out whether it's still actively enrolling patients and whether there's a site near me where I could even participate?
5Before considering this trial, are there standard treatment adjustments — like changing my current medications for secondary hyperparathyroidism — that might address my calcification risk without me needing to join a research study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in serum calcification propensity (T50)