The Effect of Increasing Dialysate Calcium on T50 in Subjects With Secondary Hyperparathyroidism and ESKD

Secondary Hyperparathyroidism Clinical Trial

— CaT50HD  

Official title:

The Effect of Increasing Dialysate Calcium on Serum Calcification Propensity in Subjects With Secondary Hyperparathyroidism and End-Stage Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06398002
• Other study ID #: CaT50HD
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: April 2024
• Source: Herlev Hospital
• Contact: Iain Bressendorff, MD PhD
• Phone: +4524277139
• Email: iain.oshoej.bressendorff[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?mol/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.

Related Conditions & MeSH terms

• End-stage Kidney Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Kidney Failure, Chronic
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iain Bressendorff

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in serum calcification propensity (T50)	Between-groups difference in T50 at day 28 adjusted for T50 at day 0	28 days
Secondary	Difference in bone-specific alkaline phosphatase (bALP)	Between-groups difference in bALP at day 28 adjusted for bALP at day 0	28 days
Secondary	Difference in procollagen 1 intact N-terminal propeptide (P1NP)	Between-groups difference in P1NP at day 28 adjusted for P1NP at day 0	28 days
Secondary	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	28 days
Secondary	Difference in parathyroid hormone (PTH)	Between-groups difference in PTH at day 28 adjusted for PTH at day 0	28 days
Secondary	Difference in calciprotein monomers (CPM)	Between-groups difference in CPM at day 28 adjusted for CPM at day 0	28 days
Secondary	Difference in primary calciprotein particles (CPP-1)	Between-groups difference in CPP-1 at day 28 adjusted for CPP-1 at day 0	28 days
Secondary	Difference in primary calciprotein particles (CPP-2)	Between-groups difference in CPP-2 at day 28 adjusted for CPP-2 at day 0	28 days
Secondary	Difference in plasma ionised calcium (iCa)	Between-groups difference in iCa at day 28 adjusted for iCa at day 0	28 days
Secondary	Difference in plasma phosphate (PO4)	Between-groups difference in PO4 at day 28 adjusted for PO4 at day 0	28 days
Secondary	Difference in plasma magnesium (Mg)	Between-groups difference in Mg at day 28 adjusted for Mg at day 0	28 days
Secondary	Difference in all above variables	Within-groups difference in all above variables at day 28 adjusted for values at day 0	28 days