The Effect of Increasing Dialysate Calcium on Serum Calcification Propensity in Subjects With Secondary Hyperparathyroidism and End-Stage Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 主要终点
- Difference in serum calcification propensity (T50)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Blinding of participants and investigators. Dialysis nurses will be aware of treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Difference in serum calcification propensity (T50)
时间窗: 28 days
Between-groups difference in T50 at day 28 adjusted for T50 at day 0
次要结局
- Difference in procollagen 1 intact N-terminal propeptide (P1NP)(28 days)
- Difference in tartrate-resistant acid phosphatase 5b (TRAcP 5b)(28 days)
- Difference in calciprotein monomers (CPM)(28 days)
- Difference in bone-specific alkaline phosphatase (bALP)(28 days)
- Difference in parathyroid hormone (PTH)(28 days)
- Difference in primary calciprotein particles (CPP-1)(28 days)
- Difference in primary calciprotein particles (CPP-2)(28 days)
- Difference in plasma ionised calcium (iCa)(28 days)
- Difference in plasma magnesium (Mg)(28 days)
- Difference in all above variables(28 days)
- Difference in plasma phosphate (PO4)(28 days)
研究者
Iain Bressendorff
MD PhD
Herlev Hospital