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Trial Title:
The Effect of Increasing Dialysate Calcium on T50 in Subjects With Secondary Hyperparathyroidism and ESKD
NCT ID:
NCT06398002
Condition:
Secondary Hyperparathyroidism
End-stage Kidney Disease
Conditions: Official terms:
Neoplasm Metastasis
Kidney Diseases
Kidney Failure, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Dialysis Solutions
Calcium
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomised, double-blind, parallel-group, controlled clinical trial
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Masking description:
Blinding of participants and investigators. Dialysis nurses will be aware of treatment
assignment.
Intervention:
Intervention type:
Other
Intervention name:
Dialysate calcium 1.50 mmol/L
Description:
Increased dialysate calcium of 1.50 mmol/L (as compared to standard dialysate calcium of
1.25 mmol/L)
Arm group label:
Dialysate calcium 1.25 mmol/L (standard)
Arm group label:
Dialysate calcium 1.50 mmol/L (high)
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 1, 2024
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Iain Bressendorff
Agency class:
Other
Source:
Herlev Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06398002
