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

NCT06398002 | Not Yet Recruiting Phase 2

• 1 other identifier: CaT50HD
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Secondary Hyperparathyroidism; End-stage Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Difference in serum calcification propensity (T50)

  Between-groups difference in T50 at day 28 adjusted for T50 at day 0

  28 days

Secondary Outcomes (11)

• Difference in bone-specific alkaline phosphatase (bALP)

  28 days

• Difference in procollagen 1 intact N-terminal propeptide (P1NP)

  28 days

• Difference in tartrate-resistant acid phosphatase 5b (TRAcP 5b)

  28 days

• Difference in parathyroid hormone (PTH)

  28 days

• Difference in calciprotein monomers (CPM)

  28 days

Study Arms (2)

Dialysate calcium 1.25 mmol/L (standard)

ACTIVE COMPARATOR

Other: Dialysate calcium 1.50 mmol/L

Dialysate calcium 1.50 mmol/L (high)

EXPERIMENTAL

Other: Dialysate calcium 1.50 mmol/L

Interventions

Dialysate calcium 1.50 mmol/L OTHER

Increased dialysate calcium of 1.50 mmol/L (as compared to standard dialysate calcium of 1.25 mmol/L)

Dialysate calcium 1.25 mmol/L (standard); Dialysate calcium 1.50 mmol/L (high)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iain Bressendorff: lead

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Iain Bressendorff, MD PhD

  Herlev and Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iain Bressendorff, MD PhD

CONTACT

+4524277139; iain.oshoej.bressendorff@regionh.dk

Ditte Hansen, MD PhD

CONTACT

+4538682056; ditte.hansen.04@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding of participants and investigators. Dialysis nurses will be aware of treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Model Details: Randomised, double-blind, parallel-group, controlled clinical trial

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP