A Phase 2 interventional study of Dialysate calcium 1.50 mmol/L in Secondary Hyperparathyroidism and End-stage Kidney Disease, sponsored by Iain Bressendorff. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-03.
Sponsored by Iain Bressendorff · Phase 2, Interventional, and Treatment
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.
188 studies on the registry are indexed under Hyperparathyroidism, Secondary; 15 are open to participants now.
This study's planned enrollment of 48 is below the median of 62 across 146 interventional studies indexed under Hyperparathyroidism, Secondary.
Browse Hyperparathyroidism, Secondary studies →Iain Bressendorff is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Dialysate calcium 1.50 mmol/L
Other: Dialysate calcium 1.50 mmol/L
Increased dialysate calcium of 1.50 mmol/L (as compared to standard dialysate calcium of 1.25 mmol/L)
Difference in serum calcification propensity (T50)
Between-groups difference in T50 at day 28 adjusted for T50 at day 0
Time frame: 28 days
Difference in bone-specific alkaline phosphatase (bALP)
Between-groups difference in bALP at day 28 adjusted for bALP at day 0
Time frame: 28 days
Difference in procollagen 1 intact N-terminal propeptide (P1NP)
Between-groups difference in P1NP at day 28 adjusted for P1NP at day 0
Time frame: 28 days
Difference in tartrate-resistant acid phosphatase 5b (TRAcP 5b)
Between-groups difference in TRAcP 5b at day 28 adjusted for TRAcP 5b at day 0
Time frame: 28 days
Difference in parathyroid hormone (PTH)
Between-groups difference in PTH at day 28 adjusted for PTH at day 0
Time frame: 28 days
Difference in calciprotein monomers (CPM)
Between-groups difference in CPM at day 28 adjusted for CPM at day 0
Time frame: 28 days
Difference in primary calciprotein particles (CPP-1)
Between-groups difference in CPP-1 at day 28 adjusted for CPP-1 at day 0
Time frame: 28 days
Difference in primary calciprotein particles (CPP-2)
Between-groups difference in CPP-2 at day 28 adjusted for CPP-2 at day 0
Time frame: 28 days
Difference in plasma ionised calcium (iCa)
Between-groups difference in iCa at day 28 adjusted for iCa at day 0
Time frame: 28 days
Difference in plasma phosphate (PO4)
Between-groups difference in PO4 at day 28 adjusted for PO4 at day 0
Time frame: 28 days
Difference in plasma magnesium (Mg)
Between-groups difference in Mg at day 28 adjusted for Mg at day 0
Time frame: 28 days
Difference in all above variables
Within-groups difference in all above variables at day 28 adjusted for values at day 0
Time frame: 28 days
No study locations are listed for this record.
Plan to share: Yes — Upon reasonable request to the investigators
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
Start is estimated for Aug 2024; primary completion for Aug 2025, 12 months later.
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This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Hyperparathyroidism, Secondary →
Iain Bressendorff