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

Launched by IAIN BRESSENDORFF · Apr 30, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of increasing calcium levels in the dialysis fluid used for patients with end-stage kidney disease (ESKD) and secondary hyperparathyroidism. Patients with ESKD often have high levels of parathyroid hormone (PTH), which can lead to serious issues like heart problems and weakened bones. The trial aims to see if raising the amount of calcium in the dialysis fluid from the standard level of 1.25 mmol/L to 1.50 mmol/L can help manage these conditions by measuring its impact on bone health and the risk of calcification in blood vessels.

To participate in this study, individuals must be at least 18 years old, have been receiving dialysis treatment three times a week for more than three months, and have specific blood test results indicating low calcium levels and high PTH levels. Participants will be randomly assigned to either receive the higher calcium concentration or stay with the standard level during their dialysis sessions. Throughout the trial, researchers will closely monitor the participants' health and gather information to understand the effects of this increased calcium. It's important to note that certain conditions, like recent bone fractures or specific treatments, may exclude individuals from joining the study.

Gender

ALL

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.