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Parathyroidectomy After Kidney Transplantation

RecruitingNAAges 18 Years - anyAllAarhus University Hospital
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In plain words

What the trial is, and whether it could suit you

This study aims to clarify whether surgical treatment of persistent hyperparathyroidism after kidney transplantation offers clinically meaningful benefits compared with a conservative treatment strategy. Kidney transplant recipients (\>6 mo after transplantation) with persistent hyperparathyroidism (elevated PTH and either hypercalcemia or hypophosphatemia) will be randomized in a 1:1 ratio to either subtotal parathyroidectomy or conservative management according to standard clinical practice. The study is conducted as an open-label, randomized controlled pilot trial with a 12-month follow-up period. Outcomes include bone density, physical function, quality of life and symptom burden.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria * Age \> 18 years and legally competent and able to understand spoken and written Danish * Kidney transplantation โ‰ฅ6 months prior (no upper limit of time after transplantation) * Stable kidney graft function, defined as estimated GFR โ‰ฅ 30 ml/min/1.73m3 * On minimum two separate biochemical measurements: PTH \> upper normal limit of assay and * serum ionized calcium โ‰ฅ1.33 mmol/L or * serum total calcium โ‰ฅ2.60 mmol/L or * serum phosphate โ‰ค0.60 mmol/L despite sufficient dietary intake with measurements obtained within * 3 months in patients 6-12 months post-transplant * 6 months in patients \>12 months post-transplant and not attributable to calcium supplementation or treatment with thiazide diuretics or lithium. Exclusion criteria * Inability to provide written, informed consent * Current anti-resorptive therapy (bisphosphonate, denosumab) * Current bone anabolic therapy (teriparatide, romosozumab) * Previous surgical parathyroidectomy * Not considered fit for surgery (including pregnancy) * Ionized calcium โ‰ฅ1.50 mmol/L or albumin-corrected calcium โ‰ฅ3.00 mmol/L despite discontinuation of calcium supplements.
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What it tests

  • Subtotal Parathyroidectomy
  • Conservative Management
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Where

1 site
Departement of Nephrology, Aarhus University hospital
Aarhus, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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