Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398002
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-30
Brief Title:
The Effect of Increasing Dialysate Calcium on T50 in Subjects With Secondary Hyperparathyroidism and ESKD
Sponsor:
Iain Bressendorff
Organization:
Herlev Hospital
Study Overview
Official Title:
The Effect of Increasing Dialysate Calcium on Serum Calcification Propensity in Subjects With Secondary Hyperparathyroidism and End-Stage Kidney Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CaT50HD
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 125-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 125 mmolL standard dialysate concentration to 150 mmolL 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
To study this further we wish to conduct a randomised double-blinded controlled clinical trial of increasing dialysate Ca from 125 mmolL standard dialysate concentration to 150 mmolL 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None